Microbiological Media disposal; To dispose of the used media properly in order to lessen Microbiology Laboratory Contamination as well as environmental pollution.
Scope
This SOP is applicable for the disposal of used Media in the Microbiology Laboratory at XX Pharmaceuticals Ltd.
Definition
N/A
Responsibilities
The roles and responsibilities are as follows:
Laboratory Attendant
Clean & disinfect used media
Executive/ Sr. Executive, Microbiology
Monitor disposal activity accordingly.
Follow the instructions of this procedure appropriately.
Follow the instructions of this procedure properly.
Asst. Manager, Microbiology
Confirm proper disposal of used media.
Confirm that this procedure is kept up to date.
Confirm suitable personnel from the section are trained in this practice.
Confirm that SOP is technically sound and reflects the required practices.
Head of Quality Assurance
Approval of this SOP
Procedure
Instructions
Appropriately wear heat-resistant gloves, eye protection, and laboratory coat during handling autoclaved media.
Avoid autoclaving the sealed containers or completely filled bottles with narrow necks as they may explode.
Don’t expose any used media container or plate outside the Laminar Air Flow cabinet.
Wash and disinfect both hands after handling used media.
Collection of Used Media
Wear suitable garments, gloves, and mask.
Wear safety goggles if hazardous media are subject to being discarded.
Collect all the media to be disposed of in the designated vessel after use.
Close the mouth of the vessel tightly.
Sterilization
Attach the Autoclave Tap with the vessel.
Place the vessel into a sterilizer and sterilize at 1210 C & 15 lbs for 30 minutes.
Check that the color of the autoclave tap is turned black.
Discard Method
After autoclaving, collect the media in a specific container when the temperature comes down to 500 to 550 C and overlay the media with 40% formaldehyde solution.
Keep the media for 30 minutes.
Dispose of the media into the drain which is linked with ETP.
Rinse the vessel properly with hot water.
Wash the vessel with detergent.
Disinfect the whole vessel with 70% Iso Propyl Alcohol and dry the vessel.
Record Maintain:
Maintain Register of Media Disposal Record in Annexure-I.
Laboratory cleaning is the vital part a pharmaceutical factory. Here Microbiology, Quality Control, Product Development Laboratory cleaning procedure has been clearly defined.
Purpose
To ensure proper cleaning and sanitizing of Quality Assurance Department in order to prevent contamination.
Scope
This SOP applies for cleaning and sanitizing of Quality Assurance Department of XX Pharmaceuticals Limited.
Definitions
Disinfectants
The specific substances which are used on the nonliving objects/ surface of the objects to kill the selective microorganism which are present on the objects/ surface of the objects. It’s not essential to kill all type of microorganism especially bacterial spores [non-resistant bacteria].
All type of Disinfectants are less effective than sterilization which kills all type of living organism. Antimicrobial agents like antibiotics are different from Disinfectants which [antibiotics] kill microorganism within the body.
Antiseptics
The specific substances which are used on the living objects/ surface of the objects to kill the selective microorganism which are present on the living objects/ surface of the objects.
Cleaning agents
The specific substances which are found generally in liquid but not limited to, use to remove dust, dirt, stains, bad smells, and clutter on the specific surfaces. The cleaning agents are used in beauty, health, to avoid shame, to absence of offensive odor, prevent spreading of dirt, contaminants to oneself and surroundings. It can kill bacteria and clean it.
Responsibilities:
The roles and responsibility is as follows
Cleaner/Lab. Attendant
Preparation of Cleaning & disinfectants solution, Cleaning & Disinfection
Microbiologist
Monitor of cleaning & disinfection
Asst. Manager, Microbiology/QC/PD
Ensure of Laboratory cleaning, disinfection and application of sound technical information.
Head Quality Assurance
Take initiative to approve of this SOP
Procedure
Instructions
Use gloves to handle the disinfectants, cleaning solution and wastage materials.
Wear gloves, mask, specific Footwear and suitable garments before entrance into Microbiology Testing area.
Disinfect the outer surface of the apparatus before transfer into Microbiology Testing area.
Preparation of Cleaning agents & Sanitizer :
Preparation of 5% Savlon/Dettol Solution:
Dilute 50 ml of Dettol/ Savlon Liquid to 1000 ml with Purified Water.
Preparation of 250 to 300 ppm Chlorine Solution:
Dilute 6 ml of Chlotec (Chlorine solution) Solution to 1000 ml Purified Water.
Preparation of Detergent Solution:
Dissolve 10 g detergent powder in Purified Water & dilute to 1000 ml with same solvent.
Cleaning and Sanitizing Microbiology Laboratory
Cleaning and Sanitization of Grade D Area.
(Media Destruction Room, Media Preparation Room, Washing area, Media Store Room, Microbiology Office, D Corridor, D Dress Off)
Floor Cleaning & Disinfection:
Enter into the specific area for cleaning.
Remove the dust particles, papers or any others dirt or dirty materials from the floor with the help of properly cleaned Vacuum Cleaner.
Sink the properly cleaned mop into the specific bucket contains detergent solution.
Clean the selective area at twice with the help of mop properly.
Wash the mop with tap water initially and finally with Purified water.
Wipe again the selective surfaces with cleaned wetted mop.
Wash the mop to clean it properly with purified water.
Sink the mop into the specific bucket containing Dettol/Savlon solution or Chlorine solution
Wipe all the selective area with Dettol/Savlon properly.
Rinse the mop properly with Purified Water.
Wipe all the selective surfaces with the cleaned mop.
Use tap water to clean the mop initially and finally clean with purified water
Use 70% IPA to sink the mop then dry it.
Keep the mop at closed condition in the designated place for the next time use after proper dry.
Use properly wetted sponges with potable water to wipe down the walls, glasses, doors, doorknobs, tables, switches etc.
Use to wipe all surfaces with Purified water.
Wash all used cleaning tools with potable water and finally with purified water.
Dry it and keep at designated place for the next use.
Clean twice a week.
Use detergent once in a week.
Cleaning and Sanitizing Quality Control Laboratory:
Floor, Wall and Others Area:
Empty the dust bins, clean them & keep them at specific place.
Clean all tables & reagent racks with the help of dry mopping.
Brush the floor of twice daily and then mop with wet mop using liquid soap.
Disinfect with prescribed disinfectant solution (2% Savlon & 1% Dettol by weekly rotation). Drain 2% Savlon & 1% Dettol solution through the sink after cleaning & then clean the sink with detergent.
Clean doors, windows & glass pans with glass cleaning agent. Sponge may be used for the purpose.
In case of spillage occur, stop the activity. Clean the spillage and resume the activity.
Clean all the instruments with a cotton duster.
Once in a week clean all the fixtures and all the racks in chemical stores with dry mopping.
Clean the walls, celling, with vacuum cleaner or with moist duster.
After cleaning the area, check the cleanliness of the area and maintain the cleaning record Savlon and Dettol solution in alternative week.
Cleaning and Sanitizing Record:
Note down cleaning & Sanitization record in Annexure-I, Laboratory Cleaning & Sanitizing Record.
[Microbiological Analysis of water; this article describes the basic procedure of Microbiological Analysis of water as per different guidelines]
Purpose
Microbiological Analysis of water; To confirm that different type of Water used for different drug processing, cleaning and drinking purpose meets the required Pharmacopoeia & In-house specifications.
Scope
This SOP applies for sampling and analysis of all types of water used in this plant.
Definition/Abbreviation
None
Responsibilities
The roles and responsibility is as follows
Lab Attendant
Sample collection of different types of water.
Executive / Sr. Executive, Microbiology
Verify, Monitoring of Sample collection, analysis of Water, and test preparation of report accordingly.
Asst. Manager/Manager, Microbiology
Confirm sampling, analysis, documentation, and application of appropriate technical information.
Review of this SOP that the whole procedure is technically informative and in execution condition.
Head of Quality Assurance
Take initiate to the approval of SOP
Procedure
Instructions
Disinfect the outer surface of the sampling point with the help of 70% IPA.
Wear sterilized latex-free gloves and an appropriate mask. Never forget to wear a beard mask where required.
Never open the sample container before & after the collection of a specific sample.
Sample Collection
Select the sampling point as per the schedule of the Water Test accordingly.
Before sampling sterilized the sampling containers for microbiology test at 1210C for 15 minutes and label it accordingly.
Wear appropriate Laboratory garments, gloves, and mask as required.
Disinfect the outer surface of the sampling points with the help of 70% IPA.
Discharge water for at least 2 minutes for the user points during the collection of sample and 1 minute for a storage tank in the water treatment plant.
Collect water from each point at least 200 ml into the sterilized container for microbiology test.
Collect the sample as soon as possible.
Close the container after sampling and don’t expose the container for microbiology test.
Sample Preservation
Samples shall be analyzed as soon as possible after being collected. If it is not possible to test the sample within about 3 hours of collection.
The sample may be preserved at refrigerated temperatures (2-80C) for maximum 12 hours to maintain the microbial attributes until analysis.
Test Schedule:
Perform the test as per the following schedule
Microbiological tests are as follows:
Potable/Pretreated Water
Perform the test as per Analytical Method
Drinking water
Perform the test as per QC Analytical Method
Purified Water
Perform the test as per QC Analytical Method
Water for Injection
Perform the test as per QC Analytical Method
Report preparation:
Report of Potable/ Pretreated/ Drinking water Test Result in Annexure-I,
Report of Purified Water Test Result in Annexure-II &
Report of Water for Injection in Annexure-IV.
Distribution of Water Test Result
After completion of the analysis, inform the status of water test to a specific department.
If any test result exceeds alert level or is out of specification, immediately inform to concerned department Head and engineering department also for corrective measurement.
After taking corrective action, Engineering Department shall inform to Microbiology Section for further sample collection.
Microbiology Section shall collect the sample from that area to carry out the analysis.
After completion of the test, inform about the test result to concerned department after approval of Head Quality Assurance
Microbial Examination of Non-Sterile Raw Materials and Products Purpose
Microbial Examination of Non-Sterile Raw Materials and Products, To confirm that the bacterial & fungal count in the non sterile products & raw materials are within the In-house / Pharmacopoeia specification & free from certain microorganisms indicated in Pharmacopeia.
Scope
This SOP is applicable for microbiological test of Non-sterile Products such such as Oral Liquid, Semi-solid, Solid preparations and Raw Materials in Microbiology Section.
Definitions
Microbial Examination: Microbial examination is designed to determine the microbial contamination in non-sterile products intended for Oral liquid, Topical Preparations or other non-sterile applications & Raw Materials.
CSDA: Casein Soyabean Digest Agar
CSDM: Casein Soyabean Digest Medium
SDA : Sabouraud Dextrose Agar
SDB : Sabouraud Dextrose Broth
TAMC : Total Aerobic Microbial Count
TYMC: Total Yeast & Mould Count
Responsibilities
The roles and responsibility is as follows:
Laboratory Attendant
Preparation Room for Microbiological Test
Microbiologist
Perform the test and incubation and in time proper documentation
Asst. Manager/Manager, Microbiology
Confirm test, incubation, report checking, document preservation and application of precise technical information.
Head of Quality Assurance
Take initiative regarding approval of this SOP
Procedure
Personal Precautions
During enter into the test area, wear sterile gloves, Lab coat and eye protection (if necessary).
To prevent unauthorized contamination, make sure that all personal ornaments, cell phone are left before entrance into the test room. The use of all type of Cell phone in the test area is strictly prohibited.
Don’t move forcefully into the test area. Move always gently.
General Requirements for the test
Glass Apparatus:
Pipette 2 ml, 10 ml
Sterilized 90 mm Glass Petridish
Screw capped Conical Flask 100 ml
Screw Capped Test Tube
Volumetric Flask 500 ml
Volumetric Flask 1000 ml
Media and Reagents:
Casein Soyabean Digest Agar(CSDA)
Casein Soyabean Digest Broth(CSDB)
Cetrimide Agar
Mac-Conkey Broth
MacConkey Agar
Mannitol Salt Agar
Meat peptone
Neutralized Peptone
Rapport Vasiliadis Salmonella Broth
Sabouraud Dextrose Agar
Xylose Lysine Deoxycholate(XLD) Agar
All of these media can be purchased from commercial available manufacturer.
Others Requirements
70% IPA or ethanol
0.45 µm Membrane Filter
Filtration Unit(sterilized filter disk and filtering funnel)
Forceps
Glass spreader
Scissors
Surgical Gloves
Surgical Cotton
Types of Test for Microbiological Examination
Enumeration Method (TAMC &TYMC)
This test quantify enumeration of mesophilic bacteria & fungi which may grow under aerobic
Condition.
Test Conditions
Wear latex free gloves, Head gear, mask and beard cover [if required], before enter into Test Room
Use 70% IPA or ethanol to disinfectant the hands, the outer surface of test sample, LAF workstation with before start test.
Perform the test under LAF to avoid contamination.
Monitor the test area microbiologically with the help of Microbial Air Sampler at each working day.
Culture Media Preparation
Prepare the different culture media as per specific requirements.
Weigh the exact amount stated in the manufacturer label into right flask.
Bring to boil completely to dissolve the media properly.
Sterilize at 1210C for 15 minutes or as directed by the Manufacturer label.
Store the prepared culture media in air tight flask properly at controlled environment.
Store the prepared agar media at 2-80C.
Preserve the dehydrated culture media up to expiry date.
Never use the expired culture media.
Use the agar media when the temperature reduce near at 450C & cool in case of the broth media.
Stock Buffer Solution
Place 34 g of Potassium Dihydrogen Phosphate[KH2PO4] in a 1000 ml volumetric flask
Dissolve in 500 ml of purified water, adjust to pH [7.2 ± 0.2] & dilute to 1000ml with purified water.
Dispense 90 ml into each screw capped flask
Sterilize at 1210C for 15 minutes.
Store the prepared buffer at 2-80C for a validated period.
Glassware Cleaning & Sterilization
Initially clean all glassware by 1% detergent & then rinse with sufficient tap water.
Finally Rinse with sufficient Purified Water to remove the residual content of detergent.
Sterilize glassware at 2000C for 1 hour.
Testing of Products
Sample Size
Collect 10 g or 10 ml of the products to be taken. 10 containers of the products from a batch.
Collect the amount is not less than the amount present in 10 dosage units or 10 g or 10 ml of the respective product, if amount per dosage unit is less than or equal to 1 mg.
Take 1% of the batch size when batch size is less than 1000 ml or 1000 gm.
Take 2 units or 1 units if the batch size is less than 100.
Types of Method
Membrane Filtration
Most Probable Number Method
Pour Plate Method
Surface spread Method
Membrane Filtration Method
Prepare sample as per Method Suitability.
Filter the sample through 0.45 µm & transfer the filter to the surface of CSDA for bacterial count and SDA[Sabouraud Dextrose Agar] for fungal count.
Incubate CSDA[Casein Soyabean Digest Agar] at [30-35]0C for 3-5 days & at [20-25]0C for 5-7 days.
After incubation, calculate the number of the cfu per gm or ml of the product.
Negative Control
Use diluents in place of test preparations. There must be no sign of growth in negative control. If found any sign of growth in negative control, the test must be invalid and repeat the whole test accordingly.
Pour Plate Method
Prepare the sample as per the Method Suitability
Pour 1 ml of prepared sample into the four 90 mm petridish, Add 15-20 ml CSDA[Casein Soyabean Digest Agar] into two plate & SDA into the others two plate.
Allow to solidify & invert all plates.
Incubate CSDA at [30-35]0C for 3-5 days and at [20-25]0C for 5-7 days.
After incubation, calculate the number of the cfu per gm or ml of the product.
Negative Control
Use diluents in place of test preparations. There must be no sign of growth in negative control. If found any sign of growth in negative control, the test must be invalid and repeat the whole test accordingly.
Surface spread Method
Prepare the sample as per Method Suitability.
Spread not less than 0.1 ml of sample on the surface of two CSDA[Casein Soyabean Digest Agar] and two SDA[Sabouraud Dextrose Agar] Plate.
Dry all plates at Laminar Air Flow.
Incubate the CSDA at [20-25]0C for 5-7 days and at [30-35]0C for 3-5 days.
After incubation, calculate the number of the cfu per gm or ml of the product.
Negative Control
Use diluents in place of test preparations. There must be no sign of growth in negative control. If found any sign of growth in negative control, the test must be invalid and repeat the whole test accordingly.
Interpretation of the results
Count as Total Yeast/ Mould Count (TYMC) on SDA plate and Total Aerobic Microbial Count(TAMC) in CSDA plate and The acceptable criterion for microbiological quality is prescribed as :
101 cfu : maximum acceptable count =20
102 cfu : maximum acceptable count =200
103 cfu : maximum acceptable count =2000
Declaration
The Material/product is passed when the observed count is less than specified count of that Material/product.
The Material/product is failed if the observed count is greater than specified count of that Material/product.
In that case, repeat the test, if the count is greater than specified count, the product is failed.
Test for Specified Microorganisms
Suitability of Test Method
Cary out the test in presence of the product. Add each test strain distinctly not more than 100 cfu at the time of product mixing with the culture media.The test will be suitable if found growth of the specific microorganism. The test will not suitable if no growth found the specific microorganism. In thatcase, add any neutralizer or increase the dilution for removal any inhibition of product.
Testing of Products
Test for E. coli
Add 10 g or 10 ml of test sample to the 90 ml of Casein Soyabean Digest Medium. Incubate at [30-35]0C for 18-24 hours.
Shake the container then transfer 1 ml of CSDM to the 100 ml of MacConkey Broth. Incubate at [42-44]0C for 24 hours.
Sub-culture on MacConkey Agar plate from MacConkey broth. Incubate at [30-35]0C for 18-72 hours.
The product complies with the test for E. coli if no red colonies are present with precipitated zone and the biochemical tests found negative[-ve].
Test for Salmonella
Add 10 g or 10 ml of test sample to the 90 ml of Casein Soyabean Digest Medium. Incubate at [30-35]0C for 18-24 hours.
Shake the container; transfer 0.1 ml of CSDM to 10 ml of RVS [Rappaport Vassiliadis Salmonella] Broth. Incubate at [30-35]0C hours for 18-24 hours.
Sub-culture on XLD [Xylose Lysine Deoxycholate] Agar plate from RVS [Rappaport Vassiliadis Salmonella] Broth . Incubate at [30-35]0C for 18-48 hours.
The product complies with the test for Salmonella if no red colonies are present with or without black centres and the biochemical tests are negative[-ve].
Test for Pseudomonas aeruginosa
Add 10 g or 10 ml of test sample to the 90 ml of Casein Soyabean Digest Medium. Incubate at [30-35]0C for 18-24 hours.
Sub-culture on Cetrimide Agar plate from CSDM [Casein Soyabean Digest Medium]. Incubate at [30-35]0C for 18-72 hours.
The product complies with the test for Ps. aeruginosa if no bluish green colonies are present and the biochemical tests are negative[-ve].
Test for C. albicans
Add 10 g or 10 ml of test sample to 90 ml of SDB [Soubaurad Dextrose Broth]. Incubate at [30-35]0C for 3-5 days.
Sub-culture on SDA[Soubaurad Dextrose Agar] plate from [Soubaurad Dextrose Broth]. Incubate at 30-350C for 24-48 hours.
The product complies with the test for C. albicans if no white colonies are present and the biochemical tests are negative[-ve].
Test Report Preparation
Report the result in Microbial Count Report of Non-sterile RM, Annexure-I.
Report the result in Microbial Count Report of Non-sterile Products, Annexure-II.
This is all about the Microbial Examination of Non-Sterile Raw Materials and Products and based on this information you can generate a SOP for Microbial Examination of Non-Sterile Raw Materials and Products.
Culture Media, To make the culture media for the development of microorganisms in the microbiological test of raw materials, In-process sample & finished products.
Culture Media Scope
This designated SOP is applicable for the preparation of Culture Media in Microbiology Laboratory at XX Pharmaceuticals Limited.
Definitions/Abbreviation:
Culture Media: The Culture media is a liquid or gel designed to support growth of microorganisms or cells or small plants. There are different type of media for growing different type of cells.
There are two major types of growth media: those used for cell culture, which use specific cell types derived from plants or animals, and microbiological culture, which are used for growing microorganisms, such as bacteria or yeast.
Responsibilities:
The roles and responsibilities are as follows:
Officer/Sr. Officer, Microbiology
To follow the instructions of the described procedure accordingly.
Asst. Manager/Manager, Microbiology
Ensure that the procedure is kept up to date.
Ensure right personnel from the section are trained on this specific procedure.
Ensure the media preparation, sterilization, requisition, maintain accurate storage & proper documentation.
To Confirm that this SOP is technically sound and reflects the required working practices as current practices.
Head of Quality Assurance
Approval of SOP
To ensure the overall implementation of the SOP
Procedure
Instructions
Dehydrated media are hygroscopic & are sensitive to light, heat and moisture. They are adversely affected by extreme changes in temperature e.g. hot/ cold cycling temperatures which may occur between day and night laboratory temperatures in winter season.
Condition of Media Preparation:
Take clean & dry flask as per required volume.
Wear appropriate Laboratory garments, gloves and mask.
Wear safety goggles during selection of hazardous media.
Storage Condition of Dehydrated Media:
Mention receipt date on the label when enter into laboratory.
Store as per directions on the label; typically below 250C in a dry area, away from direct sunlight, autoclaves, drying ovens or other heat sources, Where indicated store at (2-8)0C.
Check expiry date on the specific label, some media have suggestively shorter shelf life than others.
Use/maintain stock in lot/batch number order. Maintain FIFO [First In First Out], FEFO [First Expiry First Out].
Do not open a new bottle until the previous bottle has been emptied. Ensure date with label on the supplied container when it first opened.
After intended use, ensure the container is tightly closed and store it into the designated storage area.
Collect/procure/order the medium in an appropriate size of container and in a quantity which harmonies to normal use requirements.
A medium in a large container which has been opened many times will deteriorate on storage. Discard the medium if the powder is not free flowing, if the colour has changed or if it appears abnormal in any way.
Temperature of media storage room/facility/area/location should be monitored through min./max. thermometer and limit shall be followed as per the media storage requirements.
List of media having designated storage condition and specific pH limit shall be prepared as per Annexure-II and shall be displayed near media storage facilities.
pH Check:
Check pH of the specific medium before sterilization with calibrated pH meter. If required adjust the pH with the help of 1N or 0.1N NaOH and 1N or 0.1N HCl solutions.
Culture Media Preparation:
Select the media as per specific requirements.
Read the instructions on the label very carefully before preparation of the specific media.
Weigh the media according to the instructions of the manufacturer of the supplied media.
Close the media container tightly just after weighing in order to avoid the moisture acquisition.
Reconstitute the media with purified water and boil it appropriately until entirely dissolve.
Distribute the reconstituted media into clean and dry flask as per requirements.
Cap the flask using cotton plug or screw cap appropriately.
Transfer the media flask into the detest room for use if instructed on the label as “DO NOT AUTOCLAVE” the media.
Sterilization:
Place all prepared media into the autoclave.
Sterilize the media at 1210C for 15 minutes.
Wait until completion of cycle, and collect sterilized media from the autoclave when the chamber temperature reduce at 600C.
Storage of Sterilized culture Media:
After completion of autoclaving activities, transfer all flasks containing the broth media to the test room for use.
Store the agar media at the warming condition (500C) into autoclave until use.
Do not keep the prepared media for more than two weeks [14 days].
Keep the prepared agar plate at (2-8)0C into the refrigerator for not more than two weeks.
Handling of Sterilized culture Media:
Ensure the aseptic condition during handle of sterilized media.
Do not de-cap or expose the sterilized media outside Laminar Air Flow or Bio-Safety Cabinet.
Record Keeping:
Keep in practice to Maintain Register for Media Preparation Record, Annexure-I and Annexure-II to keep record for list of media with storage condition and pH limit.
Maintenance of ETP: This SOP [Maintenance of ETP] will make as per SOP for SOP of the respective company/Organization. Font/line spacing/Margin/Page set up/Header/Footer etc. will change as per requirement of SOP for SOP.
1.0 Purpose:
The purpose of this SOP is to define the standard procedure of preventive maintenance of Effluent Treatment Plant [ETP] of XX Pharmaceuticals Ltd.
2.0 Scope:
This Standard Operating Procedure applies to the Effluent Treatment Plant [ETP] of XX Pharmaceuticals Ltd.
3.0 Definitions/Abbreviation:
ACF: Activated Carbon Filter
ETP: Effluent Treatment Plant
MGF: Multi Grade Filter
PAC: Poly Aluminum Chloride
PPE: Personal Protective Equipment
SOP: Standard Operating Procedure
4.0 Responsibilities:
Engineering Department [Validation]:
Preparing the SOP & revise it when required
Engineering Department [Maintenance]:
To provide essential support for maintenance of the system.
To ensure that the operators are accountable to carry out the maintenance.
Operators
To perform the maintenance activities according to the SOP.
Head of Engineering
To confirm that the maintenance of ETP are done correctly.
Head of Quality Assurance
To ensure overall implementation of this SOP.
5.0 Revision Details
Sl. No./Version No./Effective Date/Change History to be add here
6.0 Annexure:
Annexure has been mentioned in bottom of the document with download link
Annexure-I: Maintenance log sheet of ETP
7.0 Procedure:
7.1 Precautions: All maintenance activities must be done safely in accordance with the necessities of the Plant Safety Declaration and the safety notices from place to place the plant. Specific consideration must be paid to the following:
Handle the chemicals by wearing PPE.
Ensure that the pumps are switched off before initiating any kind of maintenance.
7.2 System Description:
The capacity of ETP is 5000 Liter/hour. The effluents from the production department come into the neutralization and equalization tanks via bar screen chambers. In this bar screen chamber the floating material/solid material is being filtered. A dosing of lime is being delivered in the neutralization tank if pH correction is needed.
The effluents are aerated in this tanks with air which is delivered by the blowers. After being neutralized in the neutralization tank the effluents goes into the equalization tank & then the effluent is relocated to the flocculation tank through effluent transfer pumping system.
A dosing of PAC [Poly Aluminum Chloride] is delivered in the flocculation tank to flocculate all the effluents. Poly electrolyte dosing [PED] is delivered in the transferring pipe of effluents from flocculation tank to the lamella.
After lamella the effluent is passed to the aeration tank. In aeration tank the effluents are aerated with air. A dosing of NaOH[Sodium Hydroxide] is provided if it is required.
There is a buffer tank after the aeration tank where 1kg of urea will be delivered after every Two months of operation. There is a line under the buffer tank to transfer the sludge to underground sludge tank & then to sludge pit by sludge transfer pumping system.
Clear water from the Buffer Tank is stored in the clear water tank. There are two pumps to transfer the clear water to final storage tank through MGF [Multi Grade Filter] & ACF [Activated Carbon Filter]. One pump is used at a time.
7.3 Maintenance Procedure:
7.3.1 Maintenance of ETP will be performed according to the following check list:
Type of maintenance: Daily
Maintenance activities:
Clean the screen bar daily.
Clean the surrounding environment of ETP.
Type of maintenance: Weekly
Maintenance activities:
Clean the control panel.
Check the electrical control panel and electrical connection.
Type of maintenance: After 2 months
Maintenance activities:
Clean the dosing tank.
Type of maintenance: After 3 months
Maintenance activities:
Change the oil of blower/compressor.
Type of maintenance: Yearly
Maintenance activities:
Clean all the tanks
Change the gear oil
Clean the clear water tank
7.3.2 Fill up the log sheet (Annexure-I) after performing preventive maintenance of ETP.
Breakdown Maintenance: This SOP [Breakdown Maintenance] will make as per SOP for SOP of the respective company/Organization. Font/line spacing/Margin/Page set up/Header/Footer etc. will change as per requirement of SOP for SOP.
1.Purpose
The purpose of this SOP is to define the procedures involved in conducting and handling breakdown maintenance activities of the equipments/machines of XX Pharmaceuticals Limited.
2.Scope
This Standard Operating Procedure applies to all equipments/ machines of GMP all area of XX Pharmaceuticals Ltd.
3.Definitions / Abbreviation:
BM: Breakdown Maintenance
SOP: Standard Operating Procedure
QA: Quality Assurance
4. Responsibilities
The responsibilities are as follows:
Initiating Department:
To inform Quality Assurance, Head of Plant Operations and Engineering Department for the breakdown maintenance of linked equipments, machines or utility rest area.
To fill up the breakdown maintenance memo and backup the carbonated copy.
To put the status label “UNDER MAINTENANCE” on the machine.
To check related machines, equipments or utility services along with Quality Assurance personnel after completion of BM Activities.
Engineering Department/Maintenance Department
To receive the BM Memo and arrange for be present the breakdown maintenance.
To assess the cause of breakdown and resolve the problems.
To oversee the BM job and update necessary record.
To fill up the BM History form for each machine after completion of Breakdown Maintenance.
To preserve the BM related documents.
Technician
To execute the breakdown maintenance by following the appropriate safety precautions
Quality Assurance
To evaluate and select disposition or further operation of products/batches under bearing
To inform Validation Department [Engineering End] to perform requalification or recalibration of the machine/equipment if it is required.
To certify that actionable and recommendation are closed.
Validation Department (at Engineering End)
To perform requalification or recalibration of the equipment/machine if it is necessary.
To issue the Breakdown Maintenance Memo for the individual sections.
Head of Engineering
To monitor actions of engineering personnel who perform the Breakdown Maintenance activities and to provide technical provision and assistance with documentation supplies.
To assessment the history files of equipment’s maintenance annually and at the time of incidence of major failures and to identify the repeated component of failures or other events.
To confirm that the equipment maintenance history files are secured in the Engineering Department.
Head of Quality Assurance
To confirm overall implementation of this SOP
5.Revision Details
Sl. No./ Version No./ Effective Date/ Change History to be add here
6. Procedure
Precautions: All maintenance work must be accomplished safely in agreement with the requirements of the Plant Safety Declaration and the safety notices around the plant. Specific consideration must be paid to the following-
Personal Protective Equipment [PPE] and clothing appropriate to the job must be worn.
Equipment must be electrically inaccessible and locked out where potential.
“Under Maintenance” status label must be attached on the machine during BM activities.
“Shifting in Progress for Maintenance Work” status label must be attached on the machine at the time of shifting for maintenance activities.
6.1 Concerned Department
6.1.1 In case of equipment, machine or utility breakdown, the related departmental personnel will label it with ‘UNDER MAINTENANCE’ status label.
6.1.2 The BM Memo will be a pre-printed, bi-layer, self-carbonated paper which will be filled up by the related departmental personnel and the original copy will be sent to the Engineering Department to evaluate and be present at the problem. The carbonated copy will be store by the relevant department.
6.1.3 The pre-printed serial no. of each page of “BM Memo” will be considered as the “BM Memo” number.
6.2Quality Assurance Department
6.2.1 Quality Assurance personnel would estimate the breakdown to assess the influence on product quality, safety, efficacy matters and take decision whether the product would be disposed.
6.2.2 Quality Assurance will inform the Validation Team [at Engineering End] after completion of breakdown maintenance to execute the requalification or recalibration of that machine if it is necessary.
6.2.3 Quality Assurance may hold the production batches if any harmful impact occurs till further study.
6.3 Engineering Department
7.3.1 Engineering personnel will receive the “BM Memo” and evaluate the reason and resolve the problems.
6.3.2 Before initiating the maintenance activities, detach unwanted services [‘LOTO Procedure’ to be followed] from the safety point of view.
The breakdown maintenance activities will be carried out according to the equipment handbook (if required) under the supervision of maintenance supervisor/Line In-charge.
6.3.3 A tag “Shifting In Progress For Maintenance” will be put on the machine during shifting to the workshop for maintenance Activities.
6.3.4 After completion of BM activities, relink the utility services and take the usage trial in presence of relevant departmental personnel and Quality Assurance personnel. After successful trial, engineering department will deliver the machine to the relevant department.
6.3.5 Engineering department shall assess the need for requalification or recalibration in discussion with Quality Assurance and document the identical in the memo. Quality Assurance in turn shall inform to production and validation team[at Engineering End] for recalibration or requalification.
6.3.6 Preventive maintenance calendar can be changed based on the rate of breakdown of a specific machine.
6.3.7 Engineering department will maintain the data record of the breakdown activities with trend analysis.
6.3.8 After finishing the breakdown maintenance activities engineering/maintenance person will fill up the “Breakdown Maintenance History Form” of that “Machine/Equipment/System” and store all breakdown related documents in Engineering Department.
6.3.9 If the Area is out of any possible harm and found okay, routine operation will be started after Quality Assurance Inspection with adequate cleaning.
6.3.10 Photocopy of all approved forms will be used. Computer generated copies of all related form can be used with proper note, mentioning in the footer-
‘’This is the computer generated form and similar in that of original form”
Selection and recruitment of Manpower: This SOP [Selection and recruitment of Manpower] will make as per SOP for SOP of the respective company/Organization. Font/line spacing/Margin/Page set up/Header/Footer etc. will change as per requirement of SOP for SOP.
1.Purpose
The purpose of this SOP is to lay down the right selection and recruitment of the Manpower as per Approved Requisition From the department through a systemic process.
2.Scope
This SOP is applicable for the all employees of the XX Pharmaceuticals Limited.
3.Definitions / Abbreviation
Selection
Sorting of Curriculum Vitaes (CVs) as per company policy then arrange Written / Oral Examination for the preliminary selected Candidate and finally prepare Merit List based on their interview[Both Written / Oral]. Sending this Merit List to the Managing Director for his valuable comments.
Recruitment
After final review by the Honorable Managing Director, discuss the facility matters with the above Listed Candidates in presence HRD Manager, Hiring Manager & Respective Department Representative [SME, Subject Matter Expert]. When both party end closer to a conclusion, Appointment Letter will be issued with Employment Agreement.
4.Responsibilities:
The roles and responsibilities are as follows:
Executive / Sr. Executive, HR & Admin:
To share the necessary format.
Head of Plant Operation:
To share the necessary format.
To brief the importance of this activity.
To implement this correctly
Head of Quality Assurance:
To approve the SOP
5.Revision Details:
Version No.00
Effective date: 22/05/20XX
Change History: New SOP
6.Annexure
Annexure I- Manpower Requisition Form
Annexure II-Evaluation Sheet for Interviewing Person.
7.Procedure
7.1 Raise the Prerequisite of Manpower by checking its need with proper explanation from the Department Head and needs to be referred to the Head of the HR & Administration as hard copy.
7.2 After receiving, the Head of HR & Administration will forward that prerequisite with a note to the Honorable Managing Director.
7.3 Arrange a circular on the basis of the need duly approved by the Managing Director for the online and offline National/International Media based on company requirement.
7.4 After circulating the prerequisite, collect CVs of multiple applicants on receiving file them accordingly and store them in a proper location.
7.5 After the due date of circular, sorted out all of them and get ready summary list for the commendable candidates, then submitted to the Managing Director for the permission of interview.
7.6 Arrange a formal Interview in the presence of the concern Head of the Department/Designee, related person from cross functional department and the Head of Human Resource/Designee.
7.7 After the completion of interview session, get ready the summary list of the appropriate and overall acceptable candidates with marking (Scale: 0~5). To sum up, submit it to the Managing Director for review and final comments for the next necessary actions.
7.8 Then, Head of HR & Administration/Designee will go for contacting the selected candidate to discuss & finalize the facility issues.
7.9 In conclusion, Head of HR & Administration will take subsequent actions for joining the required personnel on due date.
8.Associate documents
Mention the linked document here
9.References
Mention reference here
This all about the SOP for “Selection and recruitment of Manpower”. This is the basic process and may be change based on company policy [but not limited to].
