In plant training report: the in plant training is the short duration training programme especially 2 to 4 weeks where the students get the practical knowledge about the industry really doing and what is happening in real life. The in plant training is very important for industry based students like Engineering and manufacturing like pharmacist, chemist etc. The training depends on the where you are face it. All industry/company doesn’t provide the same opportunity though they are similar. Rules, regulations, facility may be slightly different from company to company.

This article has been designed to give the basic idea about the pharmaceutical company manufacturing process and supporting department activities in pharmaceutical company. This in plant training report has describe the basic function of the company. This may be helpful to prepare a plant training report- A basic in plant training report consist of the following thing-

About XYZ Pharma Ltd.

The State of the Art manufacturing facilities of XYZ Pharma Ltd., is located in 117 Adams Street, Brooklyn, NY 11201, USA. The total land area of this site is 35 acres.

The manufacturing site is built with strict compliance to WHO cGMP standards and also to meet US FDA and UK MHRA requirements.

Delivering XYZ’s core values through a responsible approach to business by introducing differentiated medicines that make a real contribution to the health sector of USA, XYZ also aims to create enduring value for the society, and deliver a sustained financial performance that will match the best in the industry.

XYZ Pharma Ltd. is also committed to delivering new, medically important and commercially successful products to the market every year. Along with its commitment to competitiveness and high performance, XYZ will continue to be led by its core values to achieve sustainable success.

XYZ Pharmaceuticals Limited is the only company in USA having five separate and dedicated facilities on over 35 acres of land for the manufacture of variety of formulations like Human Insulin, Low molecular weight heparin, Cephalosporin, Penicillin, Ophthalmologic, SVPs, Dialysis Fluids and LVP etc. Besides its regular formulations like solids (Tablets, Caplets, Capsules), liquids (Syrup, Suspension, powder for suspension), creams & ointments.

PPL is committed to the best use of available technology and expertise of the time and thereby ensuring continuous improvements with regards.

XYZ Pharma Limited have introduced a new business division besides human health care is Animal Health Division which is committed to serve the best and becoming a leader in Veterinary Medicine sector in this country .

XYZ Agrovet the world-class healthcare solution provider, is one of the leading and fastest growing Agrovet company of USA, which is engaged in the manufacturing , sales & Marketing of a wide range of therapeutic drugs in the country through own distribution network.

Agrovet Division has launched its journey to helping millions of lives for the better through providing access to safe, effective and affordable veterinary medicines and related services to the people who need them. We have a leading portfolio of medicines that prevent, treat and cure diseases across a broad range of therapeutic areas, and an industry-leading pipeline of promising new products in areas such as infusions, Hormone and vaccines.

We know that we can best ensure the quality and innovative medicines in Veterinary medicine sector in USA . XYZ Agrovet Division offers information and support to help better understand the medicines to Veterinary doctors may prescribe as well as the farmer can be benefited with profitable Dairy, Poultry or fish farming.

Mission: Is to achieve business excellence through quality by understanding, accepting, meeting and exceeding customer expectations. XYZ follows International Standards on Quality Management System to ensure consistent quality of products and services to achieve customer satisfaction.

Vision:XYZ built on the foundation of providing the highest quality products aims to be among the top echelon of animal healthcare companies across the world servicing the needs of every animal sector.

The huge production capacity of XYZ Pharma Ltd. is now being utilized for its own product portfolio and contract manufacturing of specialty products for fourteen leading pharmaceutical companies of USA.

Following Pharmaceutical companies manufacture their specialty product in the state of the art manufacturing facilities of XYZ …………

Objectives Our Internship

To enrich the practical knowledge of the students, the university insists the students to offer the in-plant training. Such in-plant training will provide an industrial exposure to the students as well as to develop their career in the high tech industrial requirements. Reputed companies are providing in-plant training to the students.

This In plant training report is generally a practical work or a project work. Students are deputed to various industrial / research organizations based on various subjects of interest allotted by their respective institutions. This practical training helps students to understand industrial and outside environment. In other words, this acts as a bridge between academic institutions and industries for various job opportunities and building future professional careers of students after completion of their degree.

Among the professions of pharmacists like community pharmacy, institutional pharmacy, whole sale pharmacy, industrial pharmacy, government service, organizational management in our country industrial pharmacy offers great opportunity to the pharmacists.

So an industrial pharmacist should have proper knowledge about drugs and also about medical progress, commerce marketing and technology. To be a pharmacist beside academic knowledge, practical knowledge is essential.

This is why after appearing the Bachelor of Pharmacy examination in-plant training was arranged by the department in renowned Pharma industries. This training has increased our academic knowledge what we learnt in the last four years. We have completed our training in XYZ Pharma Limited a fast growing Pharma company in USA.

Description about the different area of pharmaceutical company-

In plant training report of Warehouse

Warehouse is an important part of any Pharma. Warehouse in pharmaceutical manufacturing plant or pharmaceutical factory is the place where raw & packaging material or spare parts of machineries are stored after import up- to go to production and from which the raw & packaging materials are delivered to the dispensing unit as per requirement for the smooth production and last of all, from where finished products go to distribution department from production unit for distribution to the market. Warehousing is normally the largest operation in the plant in terms of area and special attention should be focused on maintaining cleanliness, freedom from infestation & orderliness. Warehouse should be maintained within acceptable temperature & humidity limit.

Main Function of Warehouse

• Receiving in-voice and purchase order from material management
• Receiving materials
• Cleaning of received materials
• Weighing of received materials and compare with purchase order
• Dispensing of materials according to DOS for production
• Receiving of finished goods from production
• Inventory of tool manufacture also maintains by warehouse
• Documentation

AREAS OF WAREHOUSE

Quarantine Area

After receiving, raw materials and packaging materials are kept for QC approval in a yellow marked area

• Materials come through a covered van and unloaded and cleaned to make it dust free.
• Then these materials are checked individually and information like name, manufacturer, manufacturing date, expiry date, quantity and etc. are recorded in the checklist.
• They are weighed and crosschecked whether they contain the same material and quantity as mentioned in the container or not.
• If it is found to be up to standard then MMR (material receiving report) is prepared and materials are kept in the quarantine area for QC (Quality Assurance Department) approval

Released Area

QC approved raw materials and packaging is generally stored in the central place of warehouse with great safety and with controlled temperature and humidity.

1. MMR is sent to the Quality Control Department; officer comes for sampling after receiving the MMR and sampled sticker are sealed. [If the receiving material is an active ingredient then 100% sampling is necessary but if it is, an excipients then (n+1) is done.
2. If the sample is found to be standard by the Quality Assurance department then released sticker is sealed and stored in the central place of the warehouse with great safety.

Dispensing Area

One dispensing officer always responsible for dispensing the materials to the production and packaging materials to the packaging areas, following things must be checked by the dispensing officer

1. Only released (green tag) materials are brought to the dispensing area.
2. The dispensing area is completely free from materials of other products.
3. Correct quantity and approved qualities of materials are being dispensed as per requisition.
4. Materials that expired first are being dispensed first i.e. to follow FIFO.
5. Documentation of dispensing

Finished Product Area

1. Finished products are also stored here for delivery.
2. Warehouse deliver the finished products as per asked by the planning department.

Rejected Area

1. If the materials fail to pass QC test, QA give rejected tag (red tag) on each and individual container or box.
2. Rejected materials are placed in the rejected area until further decision for final disposition is made (official letter is sent to respective department).

Packaging Products Area

Imported packaging products are stored in a separate room beside the raw material storing room in the warehouse with great care.

Special Area

This is a special room or area for stored light & heat sensitive materials like colors, flavors, vitamins poisonous materials, flammable materials etc. in maintaining temperature in between 20-25ºC.

QC Sampling Room

In this separated and lab- based room, when a new material arrives in the warehouse QC officer comes here for sampling test.

Change Room for Warehouse Officers & Workers

When any officer or worker works in the warehouse, before entering in the warehouse, he or she change his/her cloths here & wears apron, shoe cover and head cover.

The main functions of Warehouse:

• Material Receiving
• Storing
• Dispensing

Materials Receiving System:

• Upon receiving the shipment’s labeling should be carefully checked to make sure that they belong to the same batch. Only materials from the same batch receive the same Good receiving Note (GRN) number. The GRN is the identification number for that raw material.
• The shipment should be inspected visually for damage.
• The materials are than carefully labeled ‘Quarantine’ with the GRN number.
• Rejected materials should be clearly separated from the ‘released’ materials.
• Rejected packaging materials containing the company’s logo are destroyed. For raw materials that are the rejected the vendor is contacted immediately.

Storage:

Raw materials and finished products are stored according to their chemical or physical properties. Some raw materials and finished products are kept at normal room condition.

In order to prevent mix-up of printed containers and labeling materials, each printed packaging material is stored properly identified with the specific GRN number and code number and at the time issues the identity is checked very carefully.

Dispensing:

Dispensing means the materials are supplied to the production areas by weighing according to the proper document and release it from the RM store.

Close attention is paid to dangers of cross-contamination. Dispensing of raw materials is done in the presence of authorized personnel from production and QA.

The remaining stock is recorded to make reconciliation of the stock possible at any time. Dispensing is done under laminar air flow to minimize dust generation and microbial contamination.

Sampling:

As the process of taking a small portion from a lot for test and analysis to show the quality of the whole lot. The purpose of sampling and subsequent testing is to provide an effective check on the quality of the product or substances being processed.

Materials sampling plan:

The materials sampling plan done on the basis of FIFO system i.e. first in first out. For active ingredients every container and for excipients √n+2 containers are sampled (where n = total number of containers).

For raw materials stores:

• Receives raw material according to the invoice/challan.
• Takes GRIR from the Q.A department.
• Updates the present status of raw materials.
• Stores all raw materials according to the instruction.
• Supplies raw materials according to the FIFO to the production floor.
• Adjust present stock after dispensing the raw material.
• Find out raw material that requires re-test.
• Find out under safety stock.

For packaging materials store:

• Receives packaging materials according to the invoice/challan.
• Takes GRIR from the Q.A. department
• Inputs the batch number.
• Store all the packaging materials according to the storage guide.
• Updates the present status of packaging materials.
• Dispense packaging materials according to the requisition from production area.
• Adjust present stock after dispensing the packaging materials.
• Find out under safety stock.

For finished products store:

• Receives finished product according to the delivery token of production area.
• Preserves the packaged product report of QA department.
• Prepares transfer note.
• Prepares VAT challan.
• Dispense FP according to FRFO basis.
• Updates the current stock of finished goods.
• Find out under safety stock.
• Maintain the proper storage condition of finished product.

Room Condition/Critical Parameter:

Temperature:  

Around 25⁰C (For finished products)

Around 20^oC (For raw materials)

Relative humidity: 

Around 60% (For finished products)                               

Around 50% (For raw materials)                              

Machineries used in warehouse:

Forklift

Sugar Crushing Machine

Trolley

 

In plant training report Solid and Liquid Production Facility

Production

The production unit of XYZ Pharma Limited is highly maintained to minimize the risk of serious medical hazard due to cross-contamination, dedicated and self contained facilities are available for the production of Pharma products.

There are adequate working and in-process storage space to permit the orderly and logical positioning of the equipment’s and materials to minimize the risk of confusion between different pharmaceutical products and their components. To avoid cross-contamination and to minimize the risk of omission or wrong application of any of the manufacturing or control steps.

Pipe works, light fittings, ventilation points and other services are designed, and sited to avoid the creation of recesses that difficult to clean.

The area is effectively ventilated, with air control facilities appropriate to the products handled, to the operations undertaken and to the external environment. These areas are regularly monitored during both production and non-production period to ensure compliance with their design specification.

Premises for the packaging (Both primary and secondary) are specifically designed and laid out to avoid mix-ups or cross contamination.

Production equipment’s are thoroughly cleaned on schedule basis they are cleaned as back to back cleaning and complete cleaning.

Function of production

• Commercial batch production
• Readjustment of instruments and facilities according to the instruction of QA department
• Small – scale experimental production of newly developed product according to the instruction of PD department.
• Supervision of raw materials and packaging and final products in connection to QC department
• Supervision of packaging process
• Calibration and maintenance of the production unit’s machinery.

Objectives

• Fulfill the market demand
• High productivity
• Reproducibility
• Quality production

Units of Production Department

Compression

Coating

Dispensing

Granulation

Encapsulation

Room Available In Production Area

Blending Room

Change Room

Clean equipment Storeroom

Compression Room

Coating Room

Dispensing Room

Encapsulation Room

Granulation Room

IPQC Room

Liquid Dispensing Room

Milling Room

Office Room

Sieving Room

Washing Bay

Selection of Production Area

Solid dosage forms are some of the least expensive, most popular and convenient methods for drug delivery.

The Solid & Liquid Department of XYZ Pharma Ltd. consists of following units:

• Tablet
• Capsule
• Powder for suspension
• Syrup
• Suspension
• Bolus
• Sachet          

Tablet

Tablets are the solid preparations each containing a single dose of one or more active ingredients and obtained by compressing uniform volume of particles.                    

According to British Pharmacopoeia, “Tablets are solid dosage forms circular in shape with either flat or convex faces and prepared by the compression or compaction of suitably prepared medicament by means the tablet machine”.

Tablets are intended for oral administration. Some are swallowed whole, some after being chewed; some are dissolved or dispersed in water before being administered and some are retained in the mouth where the active ingredient is liberated.

Essential qualities of good tablets:

1. They should be accurate and uniform in weight.
2. The drugs should be uniformly distributed throughout the tablet.
3. The size and shape should be reasonable for easy administration.
4. The tablet should not be too hard that they may not disintegrate in the stomach.
5. They should be chemically and physically stable during storage.
6. They should not break during transportation or crumble in the hand of the patient.
7. There should not be any manufacturing defects like cracking, chipping or discoloration.
8. After disintegration they should be readily dissolved.
9. They should be easy and economical in production
10. They should attractive in appearance

Types of Tablet According To BP

• Conventional/Uncoated tablet
• Coated tablet
• Effervescent tablet
• Soluble tablet
• Gastro-resistant tablet
• Modified-release tablet
• Tablet for using in the mouth

Methods of tablet preparation:

• Wet granulation
• Dry granulation
• Direct compression

Granulation:

Granulation is the process in which primary powder particles are made to adhere to form larger multi-particulate entities called granules. Pharmaceutical granules typically have a size range between 0.2 and 4.0 mm depending on their subsequent use.

Reasons for granulation:

• To improve the flow properties of the powder mix.
• To improve the compaction characteristics of the powder mix by adding a solution binder.
• To improve mixing homogeneity.
• To decrease dusting.
• To increase the bulk density of the powder mix & thus ensure that the required volume of can be filled in to the die.

Classification of Granulation

Two types of granulation process are performed in this unit

Wet Granulation

In this method water media is used for granulation. This is the most XYZ way to form tablet granules. The steps of tablet wet granulation are:

DRY GRANULATION

This method is used for powders, which require granulation and sensitive to moisture and water.

Critical parameters of granulation

1. In CMG-

• Mixing time &
• Agitator & side cutter starting

2. In FBD-

• Inlet temperature
• Exhaust temperature
• LOD

Blending

Blending is the process of mixing lubricants, glidants and colorants with the granules prior to compression (in case of granules containing the active Ingredients) or mixing of active ingredient/s along with lubricants, glidants and colorant with the placebo granules (in case of granules without the moisture sensitive active ingredients) prior to compression. So, the process is often-called lubrication or remixing.

Blending procedure

For granules containing active ingredient/s the following procedure is used in the blending units of XYZ Pharmaceutical Limited;

• Remove the blender cleaned label & update the logbook with product detail.
• Display a product identification label at the display board.
• Verify that the instruments to be used are within their calibration period Matcon IBC blender process timer. Blend Speed Indicator.
• Check that the lid is securely fitted to the IBC.
• Blend the IBC for 20 minutes at 15 rpm
• Include the blender printout in the batch wallet.
• Verify that the balances used for the IBC weighing are within their calibration period.
• Weigh the IBC to determine the granules yield.
• The weight of granules should be between 309.054 kg to 312.176 kg (99-100%).
• Notify Executive if the yield is outside the limits. Executive to investigate and provide a reason.  

BLENDING CRITICAL PARAMETERS:

• Blending time
• RPM (Rotation Per Minute)

Sieving

The sizing (size reduction, milling, crushing, grinding, pulverization) is an impotent step (unit operation) involved in the tablet manufacturing.

In manufacturing of compressed tablet, the mixing or blending of several solid ingredients of Pharma is easier and more uniform if the ingredients are approximately of same size. This provides a reater uniformity of dose. A fine particle size is essential in case of lubricant mixing with granules for its proper function. 

Sieving process

• Record temperature and relative humidity of the area before sieving.
• Remove the equipment-Cleaned label. Update the log book with product details and display a product identification label at the room entrance.
• Check that the raw materials are correctly labeled and sealed and have been weighted.
• Transfer the following raw material into 1000 L IBC
• Sieve the following raw materials through the Russell Finex Sieve fitted with 630 μm pore size screen into a labeled polybags.

COMPRESSION

After granulation, the granules are compressed to form tablets of definite Shape, size, hardness, weight & thickness. Compression unit of solid Department of XYZ Pharma has 2 compression machines. 

Compression can be defined as the technique of applying force or pressure to the granules or powders (in case of direct compression) to produce tablets of desired shape and size with the help of tablet press machine.  

Two types of compressions are seen in the tablet press units of the factory; they are-

1. Compression of previously made granules
2. Direct Compression

Direct Compression This is another method of tablet manufacturing. The materials are directly compressed to form tablets. The steps of direct compression are:

Processing problems in tablets:

Capping and Lamination:

Capping is term used to describe the partial or complete separation of the top or bottom crowns of the tablet.

Lamination is the separation of a tablet into two or more distinct layers.

These problems can be overcome by:

1. Reducing the percentage of fine in the granulation.
2. Maintaining desired moisture level in the granulation.
3. Adjusting the speed and compression force.
4. Replacement of defective punches and dies.

Picking and Sticking:

The term picking signifies the removal of material from the surface of the tablet and its adherence to the punch face.

Sticking refers to the adherence of tablet material to the die wall. This result in difficulty in the ejection of tablet which may causes further chipping of tablet edges.

These problems can be overcome by:

1. Proper designing of punches.
2. Chrome plating punch surface. 
3. Adequate drying of granules.
4. Using antiadherent like talc, magnesium stearate and colloidal silica.

Mottling:

It refers to the unequal distribution of color on the surface of tablet. It is due to difference in the color of drug and excipients, improper distribution of colorants or migration of dye to the surface of granulation during drying.

This problem can be overcome by:

1. Using a dye that can mask of all ingredients.
2. Using the alternate solvent system for the granulation.
3. Reducing the drying temperature of the granules.
4. Using dyes and lakes of very fine particle size.

Weight variation:

This problem is encountered when the tablets do not have a uniform weight. This problem is associated with poor flow of the granules, segregation of the different of the granulation or incorrect lubrication of granulation.

This problem can be overcome by:

1. Using granules of uniform particle size distribution.
2. Decreasing the fine.
3. Using proper concentration of lubricants, glidants etc.

Hardness variation:

This problem is encountered when the tablets vary significantly in their hardness. Hardness depends on the weight of the materials being compressed and the space between the upper and lower punches during the compression. If the weight of the materials or the distance between the punches varies, the hardness will also vary.

Double impression:

This problem is generally evident in cases where the lower punches have a monogram or other engravings on them. On some machines, the lower punch is free to drop and travel for a short distance before ascending to eject the tablet out of the die. During the free travel period, the punch may rotate and make a new lighter impression on the bottom of the tablet. This problem can be overcome by controlling the undesirable movement of the punches.

Tablet Coating

Tablet coating can be defined as the extra layer of the outer surface of the tablet, which mask the unwanted taste of the tablet and makes it palatable to the patient.

Tablet coating is the application of a coating material to the exterior of a tablet with the intension of conferring benefits and properties to the dosage form over the uncoated variety. 

Function of Coating

Integrate another drug or formula adjuvant in the coating to escape chemical incompatibilities.

Cover the taste, odor or color of the drug.

Deliver physical and chemical protection of the drug.

Regulate the release of drug from the tablet.

Provide safeguard to the drug from the gastric environment of the stomach with an acid resistant enteric coating.

Recover the pharmaceutical elegances by use of special colors and contrasting printing.

Main types of tablet coating:

Sugar coating

Film coating

Sugar coating:

A compressed tablet may be coated with suitable color and/unicolor sugar. This coating layer is very much water-soluble and readily dissolve after swallowing. 

Sugar coating process involves four separate operations:

Sealing

Sub coating

smoothing

Polishing and finishing

Film coating:

This is the most popular coating form nowadays. More than 95% coating demonstrate film coating except enteric coating.

Following materials used for film coating:

Film formers:

These are mainly polymers and the base of a coating formula. These can be-

Non enteric:

Methylhydroxy Ethylcellulose, Hydroxypropyl Methylcellulose, Ethyl cellulose, Na-CMC Povidone (PVP)-30 etc.

Enteric:

Hydroxypropyl Methylcellulose Phthalate, Polyvinyl acetate Cellulose acetate Phthalate, Phthalate etc.

Solvents:

Ethanol, Isopropanol, Methanol, Methylene chloride etc.

Plasticizers:

Glycerin, Propylene glycol, Polyethylene glycol etc.

Opaquant-extenders:

Aluminium silicate, Magnesium oxide, Titanium dioxide, etc.

Colorants:

FD&C and D&C colorants.

Miscellaneous coating solution components:

Flavors, Sweeteners, Preservatives etc.

Defects of coated tablet

Cracking

Core erosion

Edge chipping/erosion                                               

Logo bridging

Logo in filling

Picking/sticking Tablet to tablet color variation

Critical parameters of coating

• Atomization pressure
• Steam pressure
• Spray pattern
• Gun to bed distance
• Spray rate
• Pan depression
• Program parameter
• Height of core sample after pre-jag drying cycle.

In plant training report of In-Process Quality Control:

During the compression of tablets, in-process tests are routinely run to monitor the process, including tests for-

• Appearance
• Thickness
• Hardness
• Friability
• Weight variation
• Disintegration
• Dissolution
• Moisture content

Capsule preparation

The word capsule is consequent from the Latin word capsules denote a small box. In Pharmacy, the term Capsule is use to define an edible package made from gelatin, which is filled with medicines to produce a unit dose mainly for oral use.

As per U.S.P. ‘Capsules are solid dosage forms in which the drug is enclosed in either a hard or soft soluble container or shell of a suitable form of gelatin.’

As per B.P., ‘Capsules are solid preparation contain hard or soft shells of various shapes and capacities, usually comprising a single dose of active ingredient.’

So the complete definition is, ‘Capsule may be well-defined as solid dosage forms with the shells of hard or soft gelatin or any other suitable material, if various shapes & capacities, containing a single dose of active ingredient. They are suggested for oral administration.

The active is filled in the empty the hard gelatin capsule shell in the form of

Powder

Pellets

There are 8 different sizes of empty hard gelatin capsule shells are available –

Capsule shell size 000

Capsule shell size 00

Capsule shell size 0

Capsule shell size 1

Capsule shell size 2

             

Encapsulation Process by Automatic Capsule Filling Machine:

For encapsulation of pellets the following procedure is done with the help of Automatic Capsule Filling Machinein the capsule filling units of XYZ Pharma Ltd.

Encapsulation

Capsules are solid dosage form in which the drug substance is enclosed in either a hard / soft gelatin soluble container or shell of a suitable form of gelatin.

Capsule encapsulation flow:

There are two types capsule filling:

1. Pellet filling process
2. Powder filling process

Encapsulation process by manual capsule filling machine:

For encapsulation of powder the following procedure is done with the help of Manual Capsule Filling Machinery hand in the capsule filling units of the industry.

Packaging

Packaging protects the products for sale, storage, distribution and use. Packaging denote evaluation, design and production of different packages. It is the convenient system for warehousing, transport, sale, logistics and consumer level use.

Packaging and package labeling have numerous purposes:

• Accessibility
• Barrier protection
• Containment or agglomeration
• Information transmission
• Marketing
• Physical protection
• Safe keeping

Packaging types:

Primary packaging:

The single unit of the package which generally direct contact with the products and protect the products from surrounding environment in undesirable conditions.

Secondary packaging:

This is the outer layer of primary packaging which supports the primary packaging and makes the product elegance outfit to the end user.

Tertiary or Master packaging:

This type of packaging mainly help during transporting of various types of light weight or heavy weight products. Also help to storage of the products for a longer period of time.

Blistering materials:

It is three types:

• ALU-ALU types
• ALU-PVC type
• ALU-PVDC type

Room condition/Critical parameter:

Temperature:  

Below 25⁰ C

Relative humidity:  

Below 60%(Manufacturing Area)                      

Below 50%(Packaging Area)

Pressure:  Positive pressure in corridor and negative pressure in room and pressure difference [12~15] Pa

IPC For packaging:

• Leak test
• Coding
• Appearance
• Stoppages/Adjustments

BMR, BPR & its activity & regulations:

BMR includes the following records:

• Batch no.
• Batch size
• Batch Quantity
• Date of requisition
• Date of commenced
• Date of completion
• Change over checklist
• Manufacturing procedure
• Name of product
• It must be checked by QA officer
• Product name
• Product line clearance

BPR means Batch Packaging Record. In this documentation the following guideline is given about packaging of a batch product:

BPR contains following records:

• Batch No.
• Batch size
• Batch Quantity
• Bulk product received
• Carton over printing record
• Change over checklist for packaging line
• Date of requisition
• Date of commenced
• Date of completion
• Name of packaging materials
• Over printing inspection
• Product name
• Product order number
• Packaging line clearance
• Printing line clearance
• Specification
• It must be checked by QA officer

Packaging Line Clearance:

It denote clearance of every packaging materials of previous batch of same or different product before packaging started.

• Previous product must be removed
• Previous packaging materials must be removed
• Check by QA officer

Machine operation & cleaning:

• Most of the machines are PLC (Programmable Logic Control) controlled.
• Some machines are manually controlled.
• Operated by skilled operator.
• Some machines have CIP (Clean in process) system such as coating machine.
• Some movable parts such as dies, punches and disc are discharged to clean in cleaning room.

Following materials are used for the cleaning

• Compressed air for plastic bottle
• Sodium bicarbonate for coating machine
• Sodium lauryl sulphate 4% (SLS) for all machine
• 70% IPA (Iso-propyl alcohol)
• Tape water

Prevention & Maintenance system:

• Cleaning room with every production floor.
• Epoxy paint in the production floor facilitate easy clean & dust free.
• Gown, musk, hand gloves are used to prevent contamination.
• HVAC system maintains “Clean Corridor Concept” (Corridor with positive pressure).
• Regular training for operators.
• Sandwich wall (45 mm diameter) maintains pressure; prevent passage of air, dust, no sedimentation & ease to clean.
• SOP for all important activities.
• Skilled operators.

Shop floor planning:

The overall arrangement of production floor during production which involve-

• Manpower scheduling
• Machine scheduling
• Packing material scheduling
• Product scheduling

And this planning occurs by the three phase in a month. This is very much useful for the appropriate utilization of existing resource. And it also prevent system lose in the production area.

Machineries used in solid & liquid area:

• Bin Lifting Device
• Blister Machine
• Bottle Washing Machine
• Cap Sealing Machine
• Cosmic Bin Blender
• Cream Manufacturing Vessel
• Cream Transfer Vessel
• Encapsulation Machine
• Fluid Bed Equipment
• Fluid Bed Dryer
• Film Coating Machine
• Homogenizer
• Liquid Filling Machine
• Manufacturing Vessel
• Sartorius
• Steam Jacket Vessel
• Storage Vessel
• Sugar Coating Machine
• Super Mixer Granulator
• Tablet Compression Machine
• Transfer Vessel
• Tube Filling Machine

Machineries used in In Process Control:

• Disintegration Tester
• Friability Tester
• Hardness Tester
• Moisture Analyzer
• Tapped Density Tester
• Weighing Balance

In plant training report Cephalosporin

Now a days, Cephalosporins are most prescribed drugs of antibiotics especially in Cefixime Trihydrate and Ceftriaxone sodium. The Cephalosporins are very commonly structurally similar to Penicillin and having beta-lactam ring structure which interfere the synthesis of bacterial cell wall hence work as bactericidal.

Cephalosporins are indicated for the treatment of infections and prophylaxis and treatment of infections caused by susceptible bacteria. The 1^st generation cephalosporins are active against Gram-positive bacteria and succeeding generations have increased activity against Gram-negative and Gram-positive bacteria.

Cephalosporin’s can be divided into five generations:

1^st   generation cephalosporins:

Cefadroxil

Cephalexin

Cephaloridine

Cephalothin

Cephapirin

Cefazolin

Cephradine

2^nd  generation cephalosporins:

Cefaclor

Cefoxitin

Cefprozil

Cefuroxime

3^rd  generation cephalosporins:

Cefdinir

Cefixime

Cefpodoxime

Ceftibuten

Ceftriaxone

Cefotaxime

4^th  generation cephalosporins:

Cefepime

Cefluprenam

Cefozopran

Cefpirome

Cefquinome

5^th  generation cephalosporins:

Ceftobiprole

Ceftaroline

Room condition/Critical parameter:

Temperature:  

Below 25⁰ C.

Relative humidity:  

Below 60% (Manufacturing area)                          

Below 50% (Packaging area)

Pressure:

Positive pressure in corridor and negative pressure in room and pressure difference 12~15 Pa.

Machineries used in cephalosporin area:

• Blister machine
• Bottle washing machine
• Dry mixing
• Leak tester
• Encapsulation machine
• Film coating machine
• Macofar micro 9 line Filling & Sealing Machine
• Tablet compression
• Powder loader
• Powder for suspension machine
• Sealing & labeling machine

Condition for different portion is given bellow:

Tablet

Humidity: Bellow 50%

Temperature: Bellow 25°C

Capsule

Humidity: Bellow 50%

Temperature: Bellow 25°C

Dry syrup

Humidity: Bellow 45%

Temperature: Bellow 25°C

Vial

Humidity: Bellow 40%

Temperature: Bellow 25°C

In plant training report of Sterile Department

The whole area of sterile section of The XYZ pharmaceuticals Ltd is covered with HEPA filter and laminar airflow. There are air lock systems with air shower and pass boxes to pass the raw materials, ampoules, vials, finished products and other sterile substances to the filling and sealing area.

They take all protective measure of aseptic techniques to prevent particulate and microbial contamination.In The XYZ  pharmaceuticals Ltd. has two divisions of sterile section, one is injectable product division and another is ophthalmic product division

In plant training report of INJECTABLE DIVISION

Injectables are sterile and pyrogens free products that planned to be administered in the body with the help syringe and needles through various routes such as intravenous (IV), intrathecal (IT),  intramuscular (IM), intraperitoneal (IP) etc. The XYZ pharmaceuticals Ltd. produces Injectables in vials and ampoules meant for administration in the body through IV or IM routes.

As the products straight go to circulation, they must be free from any microbial contamination, toxic components and should have and remarkably high level of purity. So, The XYZ pharmaceuticals Ltd. has distinct section for injectables, which comprise of several sub units.

In The XYZ pharmaceuticals Ltd. produce three types of injectable products, they are-

• Aseptic products
• Terminally sterilized products
• Powder for injection

Sterilization:

Sterilization is the progression of killing or removing bacteria and all forms of living microorganisms and their spores from preparations.

Methods of sterilization:

Moist heat sterilization:

It is used to sterilize ampoules, glass bottles, vials, rubber closures and different parts of equipment.

It is also cast-off to sterilize dressings, gowns etc.

Dry heat sterilization:

It is used to sterilize glass bottles, ampoules vials, and closures.

It is also used to sterilize different parts of equipment.

Radiation sterilization:

By using gamma radiation a great number of pharmaceuticals including minerals, vitamins, antibiotics and peptides are sterilized. It is mainly used for the sterilization of surgical gowns, plastic containers, syringes, petridishes, hood and mask etc.

Ultraviolet light is usually used for the reduction of air born contamination in the aseptic room and the area of working surface.

Gaseous sterilization:

Ethylene oxide is cast-off in the terminal sterilization of medical device including tubing, dressing, intravenous infusion sets, syringe and needles etc.

Formaldehyde is mostly used for the fumigation of empty air flow cabinets and rooms to eliminate microbial contamination from solid surface.

Filtration sterilization:

It is perfect for the sterilization of thermolabile substances.

For both sterilization and amplification.

The method is beneficial for sterilization of great quantities of solutions.

Lyophilization:

Lyophilization (well known as Freeze-drying) is a dehydration procedure characteristically used to preserve a fresh material or make the material more suitable for transport. Freeze-drying works by freezing the material and then dipping the surrounding pressure to permit the frozen water in the material to sublime straight from the solid phase to the gas phase.

Environment monitoring:

Environmental monitoring is one of the most important tasks in the sterile department. It is a regular check of view to take timely corrective measures for maintaining a favorable manufacturing environment.

Gowning System:

In the manufacture of sterile drugs Gowning System is most important.

The gown must be sterilized and made of material, which will not shed particles.

Everyone entering a clean or a sterile area must change gear garments and wear special garments, which includes head, musk and footwear.

The number of people must be as low as possible and restricted to authorized people.

Room condition/Critical parameter:

Filling containers under aseptic conditions is the most critical step in the production cycle.  The most effective ones are claimed to retain 99.997% of the particles. Laminar Air flow cabinet is used under HEPA filters and air velocity is 0.45 ms-1. Filling area is class-A zone whereas the background is class-B zone.

Temperature:   

Below 250 C.

Relative humidity:  

Below 60% (For liquid vial).                           

Below 35% (For powder for suspension).

Pressure: 

Negative pressure in corridor and Positive pressure in room and pressure difference 12-15 Pa.

Aseptic Room Preparation:

The purpose of the aseptic technique is to prevent microorganisms from the environment.

To design of an aseptic room the following factors must be borne in mind:

Site

Size

Windows

Doors

Surfacing materials

Services

Corridors

The aseptic procedure comprises the following steps:

Sterilization of equipment’s

Sterilization of containers

Sterilization of gown.

Filling of the solution in the containers under aseptic conditions

Double door air lock system.

Pass box for materials.

Filling containers under aseptic conditions is the most critical step in the production cycle. This technique is filtration sterilization. HEPA (High Efficiency Particulate Air) filter is used. The most effective ones are claimed to retain 99.997% of the particles. Laminar Air flow cabinet is used under HEPA filter. Filling area is class-A zone whereas the background is class-B zone. The processing rooms must be supplied and flushed with air under controlled positive pressure.

Machineries used in SVP & ophthalmic area:

Weighing Balance

Manufacturing Vessel

FD Manufacturing Vessel

Autoclave

Eye drop Filling, Sealing &

Plugging Machine

PH Meter

Integrity Test Machine

Capping Machine

Ampoule Leveling Machine

Insulin:

This act as hormone central regulate carbohydrate and metabolism in the body. Insulin relating cell as muscle, liver and fat tissue take glucose from the blood and store it to the muscle and liver as glycogen form.

Insulin inhibit the release of glucagon by stopping the use of fat as an energy source. When body face metabolic syndrome and metabolic disorder diabetes mellitus release excess amount of glucose from the blood that is harmful for body tends to toxic condition.

Room condition/Critical parameter:

Temperature:   Below 250 C.

Relative humidity:   Below 60% (Manufacturing area).

Pressure:  Positive pressure in corridor and negative pressure in room and pressure difference 12-15 Pa.

Machineries used in insulin area:

Chutian Vial Filling & Plugging Machine

Dryer

Electrolab Vial Filling Machine

Insulin Cartage Filling & Stoppering Machine

Insulin Cartage Washing Machine

Manufacturing Vessel

Prefilled Syringe Machine

Rotary Vial Washing Machine

Rotary Ampoule Filling Machine

Dialysis

The dialysis process remove the excess water from the blood and this process primarily use in the people who are facing kidney impairment. This process also use in the people with severe kidney dysfunction.

There are two primary types of dialysis:

Hemodialysis:

Generally, the Hemodialysis process remove water and wastes by circulating the blood outside body via an external filter. This system is known as dialyzer contains a semipermeable membrane.

Peritoneal dialysis:

In peritoneal dialysis process, remove water and wastes by circulating the blood inside body by using peritoneal membrane. The peritoneum is a natural semipermeable membrane.

There are three type of Dialate preparation in XYZ pharmaceuticals ltd.

Dialysis Solution A:      Acidic product, pH(1.8-2.8)

Dialysis Solution B:      Basic product, pH (7-9)

Dialysis Solution AC:   Acetate product, pH(7.2-7.4)

Room condition/Critical parameter:

Temperature: Below 250C               

Relative humidity: Below 60%

Machineries used in dialysis area:

Manufacturing Vessel

Transfer Pumper

Pressure Vessel

Filling Machine

In plant training report Infusion Unit

As the infusion introduced to the systemic circulation of the patient so highest quality and purity strictly maintained in every steps of the manufacturing process.In XYZ Pharmaceuticals the quality & purity of infusions products are maintained strictly. They mainly produce dextrose saline.

The infusion preparation involves Two main operations-

• Preparation of WFI
• Preparation of solution

The whole area of sterile section of The XYZ pharmaceuticals Ltd is covered with HEPA filter and laminar airflow. There are air lock systems with air shower and pass boxes to pass the raw materials, ampoules, vials, finished products and other sterile substances to the filling and sealing area. They take all protective measure of aseptic techniques to prevent particulate and microbial contamination.

In The XYZ pharmaceuticals Ltd. has two divisions of sterile section, one is injectable product division and another is ophthalmic product division.

Injectables are sterile and pyrogens free products that intended to be administered in the body with the help syringe and needles through various routes such as intravenous (IV), intramuscular (IM), intrathecal (IT), intraperitoneal (IP) etc.

The XYZ pharmaceuticals Ltd. produces Injectables in vials and ampoules meant for administration in the body through IV or IM routes. As the products directly go to circulation, they must be free from any microbial contamination, toxic components and should possess and exceptionally high level of purity. So, The XYZ pharmaceuticals Ltd. has separate section for injectables, which consist of several sub units.

In The XYZ pharmaceuticals Ltd. produce three types of injectable products, they are-

• Aseptic products
• Terminally sterilized products
• Powder for injection

LVP stands for large volume parenteral liquid. XYZ Pharmaceuticals Ltd. produces a variety of infusion products

Cholera saline

Ciprofloxacin 0.2% w/v

Dextrose 5% w/v

Dextrose 10% w/v

Dextrose 5%w/v and Sodium Chloride 0.9% w/v

Hartmann’s solution

Levofloxacin 0.5% w/v

Metronidazole 0.5% w/v

Sodium Chloride 0.9% w/v

Amino Acid

The amino acids consider the building block of the proteins and act as intermediates in metabolism. There are almost twenty amino acids found in the protein convey the wide range of chemical variety. The amino acids are consider the critical to the life as its form protein in the body and have the central role in the biochemistry.

The amino acids are also use in food technology, food supplement, nutritional supplements and fertilizer. Fatty emulsion Normal saline [0.9% Sodium Chloride], Dextrose solution and is used to provide nutritional supplements.

Room condition/Critical parameter:

Temperature:  

Below 25⁰ C.

Relative humidity:  

Below 60% (Manufacturing area).                              

Below 50% (Packaging area).

Pressure: 

Positive pressure in corridor and negative pressure in room and pressure difference 12-15 Pa.

Machineries used in LVP & amino acid area:

Automatic Filling & Sealing Machine

Cartage Filter

Desktop Filling Machine

Filter Integrity Tester

Homogenizer

Manufacturing Vessel

Sealing Machine

Superheated Water Spray Autoclave

Cleaning and Maintenance:

The manufacturing vessel is fitted with a mobile auto cleaning in place (CIP) and sterilization in place (SIP) unit from Pharmalab. CIP is done with (80-90)°C WFI.  When filling starts the first 8 to 10 bags are rejected to make sure the cleaning WFI is fully expelled from the system.

In plant training report Quality Assurance

Quality Assurance refers to a program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

Quality Assurance Activities

Change Control Request

Customer complain handling

Corrective action, preventive action (CAPA)

Internal audit i.e. self-inspection

In process Quality Control[IPQC]

Out of specification

Quality incident report

Regulatory activities

Training of GMP and SOP

Vendor Audit

Validation

List of documents for audit:

Annual product review

Cleaning validation

Customer Complaint

Change control Management

Documents and trend analysis of water system

Documents and trend analysis of environment monitoring

Deviation Handling

Hold time study documents

Internal quality audit/Self Inspection

Out of specification

Product recall

Process validation documents

Qualification documents of water system

Qualification documents of HVAC system

Qualification documents of relevant process machine

Quality manual

Quality incident report

Real time stability

Site master file

Safety, Health & Environment policy

SOP list & SOP files

TSE/BSE related document

Training related document

Validation master file

Vendor audit schedule

Vendor list

Validation

Its establish the documentary evidence where a process, procedure and activity carried out and in production stage, it can be maintain compliance in all stages.

Cleaning Validation

Process Validation

Analytical Method Validation

Computer System Validation

Qualification includes the following steps:

Design Qualification (DQ):

Demonstrate the operational and functional specification of a program, instrument or equipment and every single details that specified the supplier as per URS [User Requirements Specification].

Installation Qualification (IQ):

Demonstrate that the equipment or a specific process meets the specifications, installed properly and all documents, components present to continue the Installation process.

Operational Qualification (OQ):

Demonstrates that the specific installed equipment’s or process operate correctly without any significant error.

Performance Qualification (PQ):

Demonstrates that the specific installed equipment’s or process operate correctly over a period and continue the process smoothly.

In-Process Quality Control

In-process Quality Control depends on the following parameters:

For tablet

Appearance

Average weight

Blend uniformity

Disintegration

Dosages uniformity

Friability

Hardness

Loss on drying (LOD)

Thickness

Variation

Weight

For Capsule

Appearance

Average weight

Close length

Disintegration Time

Empty Capsule shell weight

Locking

Uniformity of weight

For Liquid

Appearance

Assay

Odor

pH

Viscosity

Weight per ml

In plant training report of Quality Control Department

The activities of the Quality control is the part of the pharmaceutical company to run the smooth operation. Drug must be tested through QC department before any type of marketing activities. A better medicinal formulation must be develop and their testing method must be validated for the evaluation of the testing method.

The head of the quality control generally has the following responsibilities:

Analyst Validation

Approve or reject of raw materials

Approve packaging materials

Approve sampling and sampling procedure

Evaluate batch records

Ensure necessary testing activities

Release intermediate, bulk and finished

Routine calibration of the equipment’s

Quality control areas:

QC Laboratory must be dedicated from the production facility of the respective industry. A well equipped laboratory must be available before starting commercial production. Adequate space must be ensure for reference stands, sample, solvents, reagents, machine etc.

Good Laboratory Practice:

GLP principles include:

Equipment’s, reagents and materials

Facilities

Performance of study

Organization and personnel

Quality assurance program

Reporting of results

Standard operating procedures

Storage of records and reports

Test systems

Test & Reference items

Sampling:

This is to be perform by QC department to ensure that the raw materials, packaging materials and any other parameters just sampled and tested properly. For the Active Pharmaceutical Ingredients [API], the sample withdrawn from each container. For the excipients, sampling is performed by the formula: √n+2, where n is the number of container.

In XYZ Pharma Ltd, Quality Control department composed of two departments. There are-

Analytical lab

Microbiological lab

Analytical lab

Products are tested in three steps:

Raw material quality control

In process quality control

Finished product quality control

Raw material quality control:

Materials must be tested as they are used in parenteral preparations and any other preparation. It must be ensure that all physiochemical parameters meets its desired specifications.

The following tests are performed:

Assay of the drug

Density of powder

Flow properties of powder

Glass test on container

Identify test on rubber closure

Particles count in vehicle

Pyrogen test for WFI

Quality Control Parameter

Raw materials specification depends upon the following parameters:

Appearance

Absorptivity

Assay (HPLC)

Bulk density

Odor

Identification

Loss on drying

Heavy metals

Melting point

pH

Residue on ignition

Specific gravity

Solubility

Sterility/Pyrogen Test

Viscosity

Turbidity

Water content

FINISHED PRODUCT

Finished product specification depends on the following parameters

FOR TABLET

Dosage uniformity

Loss on drying (LOD)

Disintegration

Dissolution

Average weight

Hardness

Friability

FOR CAPSULE

Average weight

Assay

Dosage uniformity

Disintegration Time

Dissolution

Loss on drying (LOD)

FOR LIQUID

Appearance  

Assay

Odor

pH

Viscosity

Weight per ml

PACKAGING MATERIALS

Check parameters of packaging materials

Aluminum foil

%of aluminium

Thickness

Width

Cartons

Breath

Color

Code No.

Dosage

DAR No.

GSM

Length

MRP

Text

Type of paper

Catch covers

Same test as done for cartons Contains no MRP.

Labels

Breadth

Chromolex papers

GSM

Length

Type of paper used:

Inserts

Breadth

Length

Offset paper are used for inserts

Text

Type of paper used:

Corrugated board/Master carton/Shipper

Type: 3 Ply or 5 Ply

Liner should be of definite grammage

Master gum should be used

Text

Machineries used in quality control department:

[Analytical Section]

Atomic Absorption Spectrometer

Centrifuge Machine

Dissolution Tester

Drying Oven

Furness Atomizer

FTIR

Flame Photometer

Fume Cupboard

HPLC

Karl Fischer Titrate

Liquid Particle Counting Machine

Muffle Furnace

Polarimeter

pH  Meter

Refrigerator

Shaking Water Bath

Shaker

Tap Density Tester

UV Spectrophotometer

Ultrasonic Bath

In plant training report of MICROBIOLOGICAL LAB

The role of Microbiology section in Quality Control Department at XYZ Pharmaceuticals Ltd. is increasing daily to include a wide variety of quality and safety issue.

Microbiology section is one of the vital sections of any pharmaceuticals to confirm quality product. The Microbiology section of Quality Control Department in XYZ Pharmaceuticals Ltd. is well decorated and separated that assesses microbial load and particulate matter of raw material as well as finished product mainly sterile product. 

Activities performed by Microbiology section are:

Floor/Environment Monitoring:

Air Particle Count

Personnel Hygiene

Settle Plate Count

Swab Test

Microbiology Lab Work:

Bioburden Test

BET/LAL Test

Microbial Assay

Microbial Limit Test

Sterility Test

Water Treatment

Following techniques generally employed for monitoring:

Airborne particle count (non-microbiological):

This is done by using particle counter.

Settle plate technique:

The Petridishes are exposed in production area contains microbiological growth media in agar incubated for 5 days at 30°C.

Surface swabs technique:

The Sterilized swabs of cotton buds readily moistened in a liquid culture media then the specific area of a surface then swabbed and sampled from that surface and incubated. Mainly applied in solid surface, personnel, equipment, garments etc.

Air sampling:

Done for microbial growth in air.

LABORATORY TEST:

Sterility test:

It is done for raw materials and product materials. 14 days are require to perform  sterility test.

Two types:

Direct method. Filtration method (mostly used).

Limit test/Contamination test:

This test is done for checking raw materials. Three types:

Filtration.

Pour plate

Spread plate.

Endotoxin test/LAL test:

The in-vitro test for determination of pyrogen with help of the lysate of amoebocytes of limulus polyphemus.

Machineries used in quality control department:

[Microbiology Section]

Analytical Balance

Compound Microscope

Centrifuge

Cooled Incubator

Dry Heat Sterilizer

Flocculation Water Bath

Incubator

Laminar Air Flow

Top Loading Autoclave

Water Bath

In plant training report of Product Development

The product development department of the pharmaceutical company play a vital role in the in terms of the development of the cost effective drugs and support the same throughout their life cycle.

This involves:

Pharmaceutical formulation:

Proceed to develop molecules into a specific dosage format as Tablet, Capsule, and Injectable etc.

Process development:

After development a successful formulation, a specific, precise, smooth process to be develop to reproduced the same in commercial scale.

Pharmaceutical analysis:

An analytical method to be develop to analysis the physiochemical properties of the molecule including physical properties, chemical structure, stability and presence of various impurities.

Pharmaceutical maintenance:

Changes or improvements require in the commercial scale i.e. analytical methods, manufacturing processes and formulation as when required.

The section also performs the following duties:

Develop specifications for all starting materials, excipients and finished products

Develop proper batch documentation system

Develop the old and new products

Identity problems and takes positive action

Validates the product formulation

XYZ Pharma Ltd. has a very well equipped and separate product development facility to carryout formulation development work and to conduct storage stability studies following ICH guidelines which is also the one of its kind in USA.Product development department prepares the manufacturing instruction, coating instruction (if necessary), packaging instruction, product specification and testing procedure file of the new product. PD develops the formulation on the basis of trial and error method.

Consists of two parts:

Formulation 

Analytical

Stability Study:

There are two methods by which stability is tested:

Real-time stability study

Accelerated stability study

Machineries used in product development department:

ANALYTICAL SECTION

Disintegration Tester

Dissolution Tester

Drying Oven

Friability Tester

Fume Cup Board

Hardness Tester

HPLC

Hot Plate Stirrer

Karl Fischer Titrate

Moisture Analyzer

pH Meter

Shaker

Ultrasonic bath

Water Purifier

Water Bath

FORMULATION SECTION

Digital High speed Mixer

Double Cone Blender

Film & Sugar Coating Machine

Fluid Bed Dryer

High Speed Mixer

Oscillating Granulator

Tablet Compression

In plant training report of ENGINEERING

Engineering Department of XYZ Pharma Ltd. plays a major role in maintaining all other departments & supplies energy to these departments.

The major utilities that serve the Engineering department are as follows:

Air compressor

Building Management System

Boiler plant

CSB (Central Service Building)

ETP (Effluent Treatment Plant)

Generator

HVAC system

Pump house

Purified water plant

Soft water plant

Pre-treatment plant

In plant training report of Power Plant:

The power plant is the major area of a pharmaceutical company. Different type of power plant use in pharma company which convert energy into electrical energy.

HVAC:

HVAC [Heating, Ventilation, and Air Conditioning] can be defined as automotive environment controlling system. This system, mainly designed based on mechanical engineering where heat transfer, fluid mechanics and thermodynamics play vital role.

This system is mainly design for medium to high industry environment and provide comfort level of Temperature and Humidity and Fresh Air the major.

Effluent Treatment Plant:

The tenacity of an Effluent Treatment Plant (ETP) is to reduce Biological Oxygen Demand (BOD) & Chemical Oxygen Demand (COD) of pharmaceutical idle chemicals, powders and waste materials which may cause severe destructive effect on environment as well as human health.

Effluent management in XYZ Pharma Ltd. is carried out through bio-spiral technology as aerobic treatment process. The capability of the plant is 30 m3/day. The quality of output is dischargeable into the public sewer or re-useable for gardening & land scarping.

Machineries used in engineering department:

Boiler

Diesel Power Generation

Gas Power Generation

In plant training report of Administration

XYZ Factory Administration Department is a supporting department that smoothing manufacturing activities.

The overall tasks of the factory administration are as follows:

Housekeeping:

Keeping the whole administration unit as well as the premise clean and attractive looking.

Canteen management:

The company has a yearly contact with a caterer who supplies meals as well as snacks. The raw food that is brought in every day is checked by supervisors to ensure desired quality.

Safety and security:

The Company has its own security personnel. For safety there are fire extinguishers and water hoses at specific location as well as emergency exits for safe evacuation.

Vehicle management:

The vehicles work on a fixed pickup and drop schedule. They are routinely maintained at fixed workshops.

Protocol:

The administration looks over the visas, accommodation and transportation of international bodies that want to visit the plant.

Waste management:

Thus, waste management is carried out to ensure that the wastes are properly separated, recycled and disposed to maintain a pollution free environment according to regulatory requirements.

Factory rules:

An employee should be careful, courteous, dignified in style and approach and maintain a decent relationship with his/her supervisor, other employees and be professional in dealing with colleagues.

An employee must be on time in attendance and discharging his/her duties.

An employee must not be inattentive without authorized leave.

Employee will refrain from smoking in the non-smoking area within the office and factory premise.

Employee should be truthful and be loyal to the organization.

Employee shall not have a direct or indirect economic interest that conflict with his/her duties and responsibilities.

Employee should be specific in cleanliness and tidiness.

Employee will refrain from willful con-compliance and insubordination, violent behavior during working hours.

Employee will catchphrase from using any XYZ properly such as vehicles, telephone, photocopies, office equipment etc. for unauthorized personal purpose.

Marketing

The process where the company generally generate their policy to specific product or group of products to the specific area of a country or whole country or the globe.

Conclusion of In plant training report

Although the Two weeks’ time of our training in XYZ Pharma Limited flew very quickly, with the co-operation of the authority and all the personnel, we have learnt a great and gathered a lot of experience which will be helpful for our future practical purposes. In every section, the respective authority cordially received us. They initiated our curiosity and interest regarding the relevant subjects. We are pleased with the behavior of every person involved in the factory. Thus, we have completed our training with great satisfaction and hope that the feeling is mutual.

The plant layout of the XYZ Pharma Limited plant at Bhaluka, Mymensingh in a word, excellent. It was, no doubt, a very well planned layout that provides an optimum use of space and ease of operation and thus contributes highly towards optimum productivity.

The plant is very well organized and the internal environment is very supportive to the employee, which is very nice since a congenial atmosphere increases the productivity of a company. The canteen is also very nice and the food menu was found to be very good, although there is always room for improvement in this regard.

One of the impressive things about XYZ Pharma Limited is its wide range of products and its quality. I was also very impressed with the maintenance of GMP and the extensive documentation of all the works kept in the in the company, complying with the ISO 9001 requirements.

Another most impressive things about XYZ Pharma Limited is that they are trying to commence such kind of product which are valuable and they are marketing it in lower price. For example the anti-cancer drug Enliven. I would like to end with a note of thanks, again, to Almighty Allah, and to everyone involved, for successful completion of this training and I hope that XYZ Pharma Limited will continue its co-operation to allow In-plant Training in future.