Quality Control

Maintenance of Desiccator

Maintenance of Desiccator; Purpose :

Maintenance of Desiccator; The purpose of this procedure is to describe the maintenance (handling and cleaning) of desiccator.

Scope :

This procedure is applicable for all desiccators in the quality control laboratory of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

Desiccant canister: A container with hygroscopic substance which induces or sustains a state of dryness in its area.

Responsibilities:

Officer/ Executive, QC

[][] To follow the instructions of this procedure correctly.

Sr. Executive, QC

[][] To ensure that SOP is followed correctly.

Manager, Quality Control

[][] To ensure that this procedure is kept up to date.
[][] To ensure appropriate personnel from the section are trained on this procedure.
[][] To confirm that SOP is technically sound and reflects the required working practices.

Manager, Quality Assurance

[][]Approval of the SOP.
[][]To ensure the overall implementation of the SOP.

Procedure:

Precaution(s):

[][]Do not touch hot samples, while transferring them from Oven/Muffle furnace to desiccator.

Operation

[][]Place about 200 g of silica (desiccant) and/or dessicant canister into the bottom of the desiccator.
[][]Set the sample platform (desiccator plate) to the desiccator.
[][]Apply a smear of grease in between lid & desiccator rim to avoid sticking of lid with the dessicator.
[][]Close the lid properly.
[][]Open the lid to retain the sample to be analyzed and close the lid again.
[][]Remove the sample after required period of time.

Cleaning

[][]Rub the desiccator, sample platform (desiccator plate) and lid with a dry, clean cloth.
[][]Laboratory Attendant will collect the silica (desiccant) to activate (in the oven at about 105°C) and then replace it to the desiccator once in a week or even more frequently when blue color of desiccant turns purple/pink.
[][]Fill up the logbook for desiccant change (as per Annexure-I).
[][]Officer/Executive, QC will check the logbook for proper condition of desiccant or the desiccant change.

Annexure:

Annexure-I: Logbook for desiccant change of desiccator.

Maintenance of Desiccator Read More »

Handling of Reference Standard and Preparation & Storage of WS

Quality Control, SOPs

Handling of Reference Standard; Purpose :

Handling of Reference Standard; The purpose of this procedure is to provide the instruction for handling of reference standard, impurity standards and standardization & storage of working standard.

Scope :

This procedure is applicable for the management of reference standard and working standard in the quality control laboratory of general block of XX Pharmaceuticals Ltd.

Definitions/Abbreviation:

Chemical Reference Standard:

Primary chemical reference standard is one that is widely acknowledged to have the appropriate qualities within a specified context, and whose value is accepted without requiring comparison to another chemical standard.

Secondary Reference Standard/Working Standard:

A secondary chemical reference standard is a substance whose characteristics are assigned and/or calibrated by comparison with a primary chemical reference standard. The extent of characterization and testing of a secondary chemical reference standard may be less than for a primary chemical reference standard.

[] CRS : Chemical Reference Standard
[] WS : Working Standard
[] USPRS : United States Pharmacopeia Reference Standard
[] BPCRS : British Pharmacopeia Chemical Reference standard
[] ICRS : International Chemical Reference Standard (WHO)
[] EPCRS: European Pharmacopeia Chemical Reference Standard

Responsibilities:

Officer/Executive, Quality Control

[] Handle reference standard properly according to manufacturer’s certificate of analysis and instruction.
[] To standardize working standard
[] ollow the instructions of this procedure correctly.

Sr. Executive, QC

[] To ensure proper handling & storage of reference standard andworking standard.
[] To keep a track of its use, use before date, current pharmacopoeias reference standard lot number and all the related documents.

Manager, Quality Control

[] To approve WS after verification.
[] To ensure appropriate personnel from the section are trained on this procedure.
[] To confirm that SOP is technically sound and reflects the required working practices.

Head of Quality Assurance

[] To ensure the overall implementation of the SOP.
[] Approval of the SOP.

Procedure:

General Note:

[] Read carefully the label of container before use of CRS.
[] After use sealed properly the CRS.
[] Handle the CRS according to material safety data sheet.
[] Ensure proper storage of CRS and WS.
[] Do not use CRS and WS after expiry.

Handling of Reference Standard:

Use one of the following Reference Standard for analysis of raw materials:
[] Pharmacopoeia Standards
[] Validated Suppliers Standards
[] In-house Reference Standards
[] Ensure that the purity of CRS is equivalent to 99.5% or higher, calculated on the basis of the material in its anhydrous form or free of volatile substances.
[] After receiving of CRS, write down the details in Chemical Reference Standard Details Record (as per Annexure-I).

[]During receiving, check the following points :

[][] Sealing condition (flip off seal for USPRS)
[][] Label on the container
[][] Part No.
[][] Lot No.
[][] Certificate of Analysis with complete information on test method.
[][] Information on optimal storage condition (Temperature and humidity).
[][] Updated material safety data sheet outlining any health hazard associated with the material.

[]Match the lot number of CRS with supplied vial.
[]Preserve all reference standard at 2-80C or according to the label of the container or according to manufacturer’s instruction.
[]Preserve all CRS up to expiry date.

[]Standardization of Working standard:

Determination of Identification:

[][]Use CRS for material identification by IR spectrometry and/or chromatographic methods.
[][]For identification, select a lot of respective raw material, which has been approved recently.
[][]Follow the approved analytical method for identification.
[][]Analyze the physical and chemical test against the reference standard.
[][]Confirm that the result is within specification and prepare the test report in Working Standard Analysis Report (as per Annexure-II).
[][]Use this lot as WS for the next routine analysis.

[]Determination of Assay:

[][]For standardization of WS, select a lot of respective raw material, which has been approved recently.
[][]Standardize this lot against the reference standard.
[][]Perform Water (by KF)/Loss on drying (whichever applicable) in twice as per specification and validated analytical method. The average of two results shall be used to determine the assay value.
[][]If the assay is performed by HPLC inject a blank, five replicate injection of standard solution, one test solution & one end standard. If the assay is performed by UV-Spectrophotometer or Potentiometer, at least analysis two samples. Percent of RSD for peak areas or readings of individual analyses should not be more than 1.0%.
[][]The content should be declared to two digits after decimal point.
[][]Prepare the report in Working Standard Analysis Report as per Annexure-II.
[][]Keep all relevant certificates of analysis, IR spectrum, chromatogram and any data regarding identification, purity and assay.
[][]A history sheet of each Working standards shall be maintained in Working Standard Preparation & Consumption Record (as per Annexure –III).

[]Labeling & Storage of Working Standard:

[][]After analysis kept sample in properly sealed clean and dry amber coloured glass vials/bottles.
[][]Prepare four vials/bottles of each working standard containing about 5 g.
[][]Prepare six vials/bottles of each working standard containing about 4 g in case of moisture sensitive materials.
[][]Affix the label on the WS Vials/bottles as per Annexure IV.
[][]On the opening of the vials/bottles, mention the date of opening on label.
[][]In order to maintain the integrity of the working standard, the dispensed vials/bottles have to be kept at the conditions indicated on the vials/bottles label. If the storage condition is 2ºC to 8ºC, store the dispensed vials/bottles in refrigerator with controlled temperature monitoring system and if the storage condition is recommended as room temperature, store the vials/bottles in a desiccator

[]Validity/Shelf Life and Consumption of Working Standard:

[][]Before preparation of working standard ensures that the manufacturer’s shelf life of respective material is valid up to more than one year.
[][]Use the working standard within one year from the date of standardization.
[][]Use the working standard of moisture sensitive material within two months from the date of opening.
[][]Use the working standard of non moisture sensitive materials within three months from the date of opening.
[][]Before use, keep refrigerated vials in a desiccator to reach at room temperature. After use seal the vial/bottle properly and store as per recommended storage condition.

[]Reference numbering system of Working standard:

[][]Assign working standard reference number in following way:
[][]Put first two letters of working standard i.e. WS.
[][]Put a hyphen (-) after the abbreviation, then a serial number of four digits i.e. 0001, again put a slash and then two digits of month i.e. 01 for January.
[][]Again put a slash (/) and then last two digits of the year i.e. XX for year 20XX.
[][]For example, First working standard prepare on January 20XX will get the Lab. Control No. WS-0001/01/XX

Discard Procedure of CRS & WS:

[][]At the time of issuing a new vial/bottle, the old/used vial/bottle shall be destroyed in following manner:
[][]Empty the contents in waste beaker containing previously prepared 0.4% sodium hypochlorite solution. Shake the dispersion of sample in container with the help of a glass rod and leave it for at least 12 hours. Then neutralize the liquid (pH 6-9) by acid/alkali and dilute the liquid 10 to 20% by fresh water and drain out slowly into designated place and clean the drain with adequate water flushing.
[][]Deface the label of the vial/bottle.
[][]Discard the vial/bottle into the specific container as broken glassware. Record the destruction details in Chemical Reference Details Record (as per Annexure-I) for CRS, and Working Standard Preparation & Consumption Record for WS (as per Annexure-III).

Annexure:

Annexure-I: Chemical Reference Standard Details Record
Annexure-II: Working Standard Analysis Report
Annexure-III: Working Standard Preparation & Consumption Record
Annexure-IV: Label of Working Standard

Handling of Reference Standard and Preparation & Storage of WS Read More »

Calibration of Glassware with Handling & Washing

Quality Control, SOPs

Calibration of Glassware: Purpose

Calibration of Glassware; The purpose of this SOP is to ensure that all glass wares are properly handled, thoroughly cleaned and calibrated accurately before use.

Scope:

This procedure is applicable for glassware handling, washing and calibration used in the different analysis of quality control laboratory and microbiology laboratory of general block of XX Pharmaceuticals Ltd.

Definitions/Abbreviation:

[] ASTM: American Society for Testing and Materials
[] SOP : Standard Operating Procedure

Responsibilities:

[] Officer/Executive/Sr. Executive, Quality Control
[] To ensure that this procedure is followed.
[] To maintain the records properly as per SOP.

Manager, Quality Control

[] To ensure that this procedure is kept up to date.
[] To confirm that the SOP is technically sound and reflects the required working practices.
[] To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
[] Schedule calibration of the instrument at the defined intervals.

Head of Quality Assurance

[] Approval of the SOP.
[] To ensure the overall implementation of the SOP.

Procedure:

Precaution(s):

[] Handle with care during cleaning of Glassware.
[] Before discard of glassware, observe the label on glassware and handle with care as the type of chemical.
[] Wear gloves, mask and protective clothing during glassware handling and cleaning.
[] Do not use laboratory glassware for drinking purpose.
[] Do not handle the hot glassware without heat resistant gloves.
[] Do not put the hot glassware on cold or wet surface or cold glassware on hot surface.
[] Avoid to heat glassware that is etched, cracked, chipped, nicked or scratched.
[] Do not heat directly thin glassware with flaming.
[] Never place the glassware from the freezer into warm water baths.

Handling Procedure:

[] Hold the beakers, bottles, flask the side and bottoms rather than by the tops.
[] Avoid over tighten the clumps.
[] Use always coated clumps to avoid breakage while the clumping glassware.
[] Cool the glassware slowly to prevent breakage.
[] Dispose the broken glass into specific waste bucket.
[] Keep all cleaned glassware at designated place.

Washing Procedure:

[] Transfer all used glassware to washing area.
[] Discard the solution from glassware into a designated container/place.
[] Rinse initially all glassware with sufficient potable water for removal the residual content of solution.
[] For pipette, pass sufficient potable water through the pipette by force at two or three times.
[] Wipe to remove the label with detergent powder or suitable solution.
[] Allow to soak the glassware with diluted detergent for 10-15 minutes to remove any contaminants.
[] Rinse the glassware with sufficient potable water until detergent is removed.
[] Finally rinse with purified water for two or three times for removal any contaminating substances that may be present in the potable water.
[] Discard the rinsing solution.
[] Place cleaned glassware into Glassware drying rack for removal of residual water from glassware.
[] Dry the glassware for QC analysis and sterilize the glassware at 200°C for 1 hour for use in Microbiological analysis.

Calibration Procedure:

Burette Calibration:

[] Take a burette and inspect to ensure smooth tap operation.
[] Observe the tip of the burette, ensure no cracks or chips.
[] Observe markings on burette which is legible.
[] Rinse the burette at several times with purified water.
[] Fill the glassware up to the mark.
[] Dispense into a pre-tarred 100 ml beaker.
[] Record final volume.
[] Record mass of water.
[] Repeat the same procedure for another two times.
[] Calculate the volume delivered from the equation below using recoded weight and density of water at the temperature of calibration. Take Tabulated Density of water at the temperature of calibration from the Annexure-II.
Volume of Burette= Weight/Tabulated Density of water at the temperature of calibration
[] Record calculated volumes, determine mean and compare the volume with that read from the burette and then determine the error as per Annexure – I.

Limit of error of the calculated volume should be as per following table (as per ASTM E-287)

Nominal Volume, mL	25	50
Limit of error, mL	0.03	0.03
Limit of error, %	0.12	0.10

Calibration of Pipette:

[] Take purified water into a beaker.
[] Record the temperature of the water used.
[] Weigh and tare another 100 ml beaker.
[] Dispense water as per pipette volume into tarred beaker.
[] Record the weight of purified water.
[] Repeat the same procedure for another two times.
[] Calculate the volume delivered from the equation below using recoded weight and density of water at the temperature of calibration. Take Tabulated Density of water at the temperature of calibration from the Annexure-II.
Volume of Pipette= Weight/Tabulated Density of water at the temperature of calibration
[] Record calculated volumes, determine mean and compare the volume with the nominal volume and then determine the error as per Annexure – I.

Limit of error of the calculated volume should be as per following table (as per ASTM E-969)-

Nominal Volume, mL	1	2	3	4	5	10	15	20	25
Limit of error, mL	0.006	0.006	0.01	0.01	0.01	0.02	0.03	0.03	0.03
Limit of error, %	0.60	0.30	0.33	0.25	0.20	0.20	0.20	0.15	0.12

Calibration of Volumetric Flask:

[] Observe the volumetric flask, ensure no cracks or chips.
[] Observe markings on volumetric flask, ensure they are legible.
[] Rinse volumetric flask at several times with purified water.
[] Rinse with acetone and air dry.
[] Tare volumetric flask on balance.
[] Add purified water and fill to mark.
[] Record weight of water.
[] Record the temperature of the water used.
[] Repeat the same procedure for another two times
[] Calculate the volume delivered from the equation below using recoded weight and density of water at the temperature of calibration. Take Tabulated Density of water at the temperature of calibration from the Annexure-II.

[] [] Volume of Volumetric Flask= Weight/ Tabulated Density of water at the temperature of calibration

Record calculated volumes, determine mean and compare the volume with the nominal volume and then determine the error as per Annexure – I.

Limit of error of the calculated volume should be as per following table (as per ASTM E-288)

Nominal Volume, mL	5	10	25	50	100	200	250	500	1000	2000
Limit of error, mL	0.02	0.02	0.03	0.05	0.08	0.10	0.12	0.15	0.30	0.50
Limit of error, %	0.40	0.20	0.12	0.10	0.08	0.05	0.05	0.03	0.03	0.025

Download All Annexure

Annexure I : Glassware Calibration Record
Annexure II : Density of Water

Calibration of Glassware with Handling & Washing Read More »

Packaging Material Sampling and Release Procedure

Quality Control, SOPs

Packaging Material Sampling and Release, Purpose :

The purpose of this SOP is to describe the procedure for sampling and releasing of packaging materials for pharmaceutical products.

Packaging Material Sampling and Release, Scope :

This procedure is applicable for all packaging materials received at the warehouse of XX Pharmaceuticals Limited.

Definitions/Abbreviation:

[] SOP: Standard Operating Procedure
[] QC: Quality Control
[] GRN: Goods Received Note
[] COA: Certificate of Analysis
[] ERP: Enterprise Resource Planning
[] Sampling: It is a process of collecting the materials so that the collection shall represent the whole lot.
[] Sampling plan: Description of the number of units and/or quantity of material that should be collected.
[] Consignment: A supply of a material of particular batch intended to be used in different department.
[] Lot: A defined quantity of material made by a specified process cycle having uniform quality.

Responsibilities:

The roles and responsibility is as follows:

Officer/Executive/ Sr. Executive, Quality Control

[] To ensure that the procedure is correctly followed.
[] To maintain the records properly as per SOP.
[] To ensure that this procedure is kept up to date.
[] To confirm that the SOP reflects the required working practices.
[] To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.

Executive/ Sr. Executive, Warehouse

[] To ensure availability of containers to be sampled in quarantine area.

Executive, Production

[] To arrange machine trial when required and share the report to QC with the concern of Manager,

Production.

Head of Quality Assurance

[] To ensure the overall implementation of the SOP.
[] Approval of the SOP.

Procedure:

General Precaution(s):

[] Take sample for microbial testing first followed by other sampling.
[] Sampling should be carried out by trained personnel.

Sampling: Packaging Material Sampling and Release

[] Receive the GRN with Manufacture’s COA from the warehouse and enter the details (GRN no., lab. control no., name of material, code no., invoice/challan no., manufacturer lot no., local batch no., manufactured by, supplied by, pack size, no. of pack, total quantity and received by & date) in the ‘Packaging Material Log Register’ (as per Annexure-I) maintained in QC department for packaging material.
[] Ensure that material is received from Approved Vendor.
[] If the material is not from approved vendor or if the Manufacture’s COA for primary packaging material is not received, inform Supply Chain Management Department.
[] QC Officer/Executive or QC sampler will select the no. of container/packs to be sampled as per sampling plan and sample quantity according to ‘Sampling quantity for Packaging Material’ (as per Annexure-II) and take required no. of “SAMPLED” label.
[] For example, when the total no. of container of inner carton (secondary packaging material) is 25, then no. of container to be sampled will be Ö 25 + 1 = 5 + 1 = 6.
[] If the batch size is 3100 pcs, then 32 pcs of inner cartons will be taken from 6 different containers.

Sampling plan:

[] The n plan

The “n plan” is based on the formula n = 1 + ÖN, where N is the number of sampling units in the consignment. The value of n is obtained by simple rounding. A minimum number of containers needs to be sampled, e.g. if N is less than or equal to 4, then every container is sampled. According to this plan, samples are taken from n sampling units (containers/pack) selected at random.

Sampling plan for primary packaging material

[] In case of primary packaging material, select no. of reels/pack/ container for sampling as per “n plan”.

Collect approximately 1 feet sample of foil/film from each of selected reels of films/foils.

[] In case of bottle/cap/dropper/stopper, take randomly 10 samples from selected containers.
[] In case of Container/Jerry can/Cap for Jerry can; check physical appearance of at least 3 samples from each selected container/pack (selected as per “n plan”) and then take randomly two containers for laboratory test from selected container/pack.

Sampling plan for secondary packaging material

[] For secondary packaging material, select container/pack for sampling as per “n plan”.
[] Samples can be withdrawn from any part of the container (usually from the top layer).
[] Collect sample proportionally from the selected container/pack following ‘Sampling quantity for Packaging Material’ (as per Annexure-II).
[] In case of Shipper carton and Master carton, check physical appearance and text of at least 3 shipper cartons from each selected pack and then take randomly 3 shipper cartons for laboratory test from selected pack.
[] Inform Warehouse before going for sampling to arrange the packaging material containers.
[] Take ‘Sampled’ label, sampling tools, packaging material sampling report, sampling basket and GRN before sampling.
[] Check the physical condition and cleanliness of packaging material containers/packs before opening for sampling.
[] If any container/pack found in damaged condition, intimate warehouse in-charge.
[] Damaged containers/packs whose integrity is doubtful should be sampled and tested separately.
Inform warehouse in-charge to take initiatives for repacking of damaged container/pack if necessary.

Sampling of packaging materials

[] Check the details given on the GRN with the manufacturers label and ensure that the “Quarantine” label affixed properly by the warehouse personnel on all packaging material containers/packs of a consignment.

[] Check the physical condition of outer pack/container/damage condition.
[] Microbiology personnel will collect sample first in sampling booth for microbial analysis (when applicable).
[] Check the physical condition such as appearance (in case of Shipper carton/Master carton, Container/Jerry can/Cap for Jerry can), winding (in case of foil/film) etc. of the packaging material for any gross abnormalities. Measure internal core diameter, total reel diameter (in case of foil/film) of three reels. [] Record all necessary information in ‘Packaging Materials Sampling Report’ (as per Annexure-IV).
[] Select number of containers/bags/packs and collect sample according to sampling plan. Repair the sampling point properly, close the container/pack and affix the ‘SAMPLED’ label in cascading manner (overlapping upto half of the status bar of the previous label) over the “QUARANTINE” label without hiding any information of the previous label. Affix ‘UNDER TEST’ label on all other containers of the consignment in the same way.

[] Enter the information about the material sampled i.e. date, GRN No., lab. control no., name of material, code no., invoice no./challan no., manufacturer lot no., manufactured by, sampled quantity, sampled by and remarks (if any) into the ‘Sampling Register for Packaging Material’ (as per
Annexure-III).
[] Record sampling details in ‘Packaging Materials Sampling Report’ (as per Annexure-IV).
[] If any discrepancy found, immediately inform the warehouse in-charge to take action accordingly.
[] Transfer the collected samples to QC laboratory.

Release:

[] On receipt of the packaging material sample from warehouse, QC will keep them into “Under test sample (packaging material)” labeled rack in sample receiving room or any other designated place with proper labeling.
[] Enter the sampled by (initial) in the ‘Packaging Material Log Register’ (as per Annexure-I).
[] In-charge/Sr. Executive, QC will issue the packaging material work sheet with initial and date on every page to the analyst and enter the worksheet issued by (initial and date) in the ‘Packaging Material Log Register’ (as per Annexure-I).
[] Carry out the physical appearance test very carefully.
[] Test all parameters according to the packaging material specification and the packaging material test method and record the analytical raw data and calculations, and attach the printout of weight(s) in the analyst logbook.
[] Fill up the respective Packaging material work sheet (as per Annexure-V) and attach printout of required raw data.
[] Accordingly prepare the ‘Certificate of Analysis for Packaging Material’ (as per Annexure-VI).
[] Use bracket like [ ] to indicate that the result is taken from manufacturer’s certificate of analysis (COA).
[] Keep a remarks on ‘Certificate’, if any minor observation (variation in dimension, colour etc.) is found for a batch of packaging material.
[] Compile a batch report with COA, test report (packaging material work sheet), packaging materials sampling report (prepared as per Annexure-IV), QC copy of GRN.
[] Keep one retention sample with the bunch if feasible.
[] If it is not possible to keep retention sample with the bunch, keep them into another box/pack with proper labeling.
[] Submit the batch report with respective packaging material specification to Executive/Sr. Executive, Quality Control for checking.
[] Check and verify the test result against Packaging Material Specification. Inform production department for machine trial or practical trial for a particular material, if required.
[] Executive, Production is responsible for machine trial and reporting.
[] On completion of checking/verification, enter the detail in the ERP.
[] Submit GRN, testing report and COA to In-charge/Sr. Executive, QC for checking and approval. Give part release to fulfill the production demand, if required.
[] In-charge, QC/Sr. Executive, QC will check report and approve finally for passed/rejected status of the packaging material.
[] Officer/Executive, QC will prepare status label (Passed/Rejected) after approval of GRN. The expiry and retest should be not applicable for all secondary packaging materials, glass bottle, ampoule, plastic container/cap/dropper/stopper/syringe, polyethylene bag, aluminium cap, sealing foil and alu-lid foil. In case of PVC, PVdC film and Alu-bottom foil; the expiry and/retest should be as per manufacturer’s recommendation. If not mentioned by manufacturer, then the expiry period for PVC, PVdC film and Alu-bottom foil should be five years.

[] Officer/Executive/Sr. Executive, QC will check and sign on the passed label.
[] Only the rejected label will be signed by In-charge/Sr. Executive, QC.
[] After release of consignment entry information regarding a passed/rejected GRN in “Packaging material log register” (as per Annexure-I).
[] After approval send copy of GRN to warehouse/Store.
[] QC Executive or QC sampler will affix status label (Passed/Rejected) in cascading manner (overlapping upto ³/₄ th of the status bar of the previous label) over the “SAMPLED” or “UNDER TEST” label without hiding any information of the previous label.
[] Enclose mail or any other relevant document and approved GRN, with the respective batch document.
[] Keep a copy of GRN with batch document and file it up.

List of Annexes: Packaging Material Sampling and Release Procedure

[] Annexure-I     : Packaging Material Log Register
[] Annexure-II    : Sampling quantity for Packaging Material
[] Annexure-III   : Sampling Register for Packaging Material
[] Annexure-IV   : Packaging Materials Sampling Report
[] Annexure-V    : Packaging Material Work Sheet
[] Annexure-VI   : Certificate of Analysis for Packaging Material

Packaging Material Sampling and Release Procedure Read More »

Storage Conditions of Raw Materials and Packaging Materials

Quality Control, SOPs

Storage Conditions of Raw Materials and Packaging Materials, Purpose:

The purpose of this procedure is to describe the instruction of storage conditions of raw materials and packaging materials.

Storage Conditions of Raw Materials and Packaging Materials, Scope:

This SOP is applicable for storage conditions of raw materials and packaging materials to Quarantine Area, Ambient Store, AC Store, Finished Goods Store, Capsule Shell Store and Central Warehouse of XX Pharmaceuticals Ltd.

Definitions/Abbreviation:

[] Ambient Store: Storage area with normal environment condition.
[] MSDS: Material Safety Data Sheet.

Responsibilities:

The roles and responsibility is as follows:

Executive, Warehouse

[] Maintain storage conditions of all raw and packaging materials as per Manufacturer’s instruction or according to specification.
[] Record the temperature and humidity of the material storage room.
[] Follow the instructions of this procedure correctly.

Executive, Quality Compliance

[] Verify the storage conditions of raw and packaging materials.

General Manager, Plant

[] Ensure that all raw and packaging materials are stored properly.
[] Ensure appropriate personnel from the section are trained on this procedure and evaluate the effectiveness of training.
[] Confirm that SOP is technically sound and reflects the required working practices.

Head of Quality Assurance

[] Approval of SOP.
[] To ensure the overall implementation of the SOP.

Procedure:

Precaution(s):

[] Precautions must be taken to prevent unauthorized entry in the storage areas.
[] All stores must be secured with lock and key.

Storage Conditions:

Maintain Storage conditions as below:
[] Quarantine Area :Below 25°C
[] Ambient Store:Below 40°C
[] AC Store:Below 25°C

Finished Goods Store:Below 30°C

Capsule Shell Store:Temperature Below 25°C & Relative Humidity Below 60%
Central Warehouse:Below 25°C

Storage of the materials:

[] Carry out the emergency plan if temperature goes above 25°C for AC store.
[] Record the temperature and humidity for the time when temperature goes above 25°C.
[] Inform QA department immediately providing all recorded data and existing product status.
[] Check the recorded data and evaluate the sensitive material, which might temperature sensitive.
[] Send the advice to Quality Control Department for retesting of that sensitive material before use in production.
[] Carry out tests as described in the respective test method.
[] Analyze the impurity of the substance, if required.
[] Affix “REJECTED” label on the existing label of the container when retesting result does not comply with specification.
[] Prepare a list for storage condition of raw materials and packaging materials as per Annexure-VII; then take approval from Head of Quality Assurance.

[] Update the list for storage condition of raw materials and packaging materials three months to yearly or when required.

Recording of storage conditions:

[] Sr. Executive/Executive, Quality Compliance will issue the ‘Temperature & Relative Humidity Record Sheet of Warehouse’ as per Annexure-I to Annexure-VI
[] Executive, Warehouse by maintaining proper record.
[] Record the temperature and humidity of Quarantine Area, Ambient Store, AC Store, Finished Goods Store, Capsule Shell Store and Central Warehouse thrice in a day in ‘Temperature & Relative Humidity Record Sheet of Warehouse’ prepared as per Annexure-I to Annexure-VI.
[] Maintain the storage condition as per QA approved Storage Condition of Raw materials and Packaging materials.

List of Annexes

1.0 Annexure-I: Temperature Record Sheet of Quarantine Area.
2.0 Annexure-II: Temperature Record Sheet of Ambient Store.
3.0 Annexure-III: Temperature Record Sheet of AC Store.
4.0 Annexure-IV: Temperature Record Sheet of Finished Goods Store.
5.0 Annexure-V: Temperature & Relative Humidity Record Sheet of Capsule Shell Store.
6.0 Annexure-VI: Temperature Record Sheet of Warehouse Central Warehouse.
7.0 Annexure-VII: Format of Storage Condition of Raw materials and Packaging materials.

Storage Conditions of Raw Materials and Packaging Materials Read More »

Manufacturing Trend Analysis Standard Operating Procedure

Quality Control, SOPs

Manufacturing Trend Analysis, Purpose:

Manufacturing Trend Analysis, the purpose of this SOP is to define a procedure for trending of manufacturing data and to ensure that management reviews the trends and takes appropriate action.

Manufacturing Trend Analysis, Scope:

This procedure is applicable for all products manufactured at general block and are analyzed in Quality Control and Microbiology Laboratory of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.
[][]QC: Quality Control.

Responsibilities:

[][]The roles and responsibility is as follows:
[][]Executive/Executive, QC & Microbiology
[][]To ensure that the instructions of this procedure are correctly followed.
[][]To maintain the records properly as per SOP.

Manager, Quality Control

[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
[][]To ensure effective assessment of trend analysis of Product.
[][]Take correction action to prevent reoccurrence.

Head of Quality Assurance

[][]Approval of the SOP.
[][]Review all trend analysis to take appropriate action.
[][]To ensure the overall implementation of the SOP.

Procedure:

[][]Manager, Quality control will issue the ‘Finished Product Trend Card’ (Annexure-I) by making entry in the ‘Trend Card Issue Register’ (Annexure-II)
[][]QC Executive will make entry in ‘Finished Product Trend Card’ and MS Excel format at the time of report submission.

Trend the following key parameters by QC Executive taken from IPC data:

Tablet:

[][]Disintegration Test
[][]Average weight

Capsule:

[][]Disintegration Test
[][]Filled weight

Powder for suspension:

[][]Filled weight
[][]Trend the following key parameters by QC Executive taken from analytical data:

Tablet:

[][]Assay (Active content)
[][]Dissolution Test (if applicable)

Capsule:

[][]Assay(Active content)
[][]Moisture content
[][]Dissolution Test (if applicable)

Powder for suspension:

[][]Assay (Active content)
[][]Moisture content
[][]Dissolution Test (if applicable)
[][]Quality Control Manager will review the trend at the time of report approval.
[][]If there are any atypical findings that indicate potential quality or performance issues, then follow the below instruction:
[][]Carry out an immediate laboratory investigation as per procedure for out of specifications. But this action will not prevent from releasing the batch to commercial.
[][]If the laboratory investigation indicates that there is no laboratory error, then it must be reported to AGM, Quality Assurance to conduct an investigation and take action to bring the situation in control.
[][]Preserve all the data securely for Periodic Product Review.

List of Annexure:

Annexure-I: Finished Product Trend Card
Annexure-II: Trend Card Issue Register

Manufacturing Trend Analysis Standard Operating Procedure Read More »

Raw Material Sampling and Release Standard Procedure

Quality Control, SOPs

Raw Material Sampling and Release, Purpose:

Raw Material Sampling and Release, the purpose of this procedure is to describe the process for sampling and release of the raw materials (actives and excipients).

Raw Material Sampling and Release, Scope:

This procedure is applicable for all raw materials (APIs and Excipients) received in XX Pharmaceuticals Limited.

Definitions/Abbreviation:

[][]QC: Quality Control
[][]API: Active Pharmaceuticals Ingredients
[][]GRN: Goods Received Note
[][]CoA: Certificate of Analysis
[][]AQL: Acceptance Quality Limit
[][]BOPP: Bi-axially Oriented Polypropylene
[][]Mfg. Date: Manufacturing Date
[][]Exp. Date: Expiry Date
[][]ERP: Enterprise Resource Planning
[][]SS: Stainless Steel

Responsibilities:

The roles and responsibility is as follows:

Officer/Executive, QC and Officer/Executive, Microbiology

[][]To ensure that the instructions of this procedure are correctly followed.
[][]To maintain the records properly as per SOP

Executive, Warehouse

[][]To ensure availability of containers to be sampled from quarantine area to the sampling booth and their
replacement after sampling.
[][]To ensure cleanliness of sampling booth and containers to be sampled.

Manager, Quality Control

[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.

Head of Quality Assurance

[][]Approval of the SOP.

Procedure:

General Precaution(s):

[][]Take sample for microbial testing first followed by other sampling.
[][]Use clean and dry sampling device for sampling.
[][]Use sampling device after moping with freshly prepared 70% IPA for collecting the sample for microbiological limit test.
[][]Material of only one consignment shall be sampled at a time.
[][]Use different sampling devices for sampling of different materials.
[][]For sampling of volatile and hazardous chemicals and solvents, follow instructions as given in their handling procedures.
[][]All solid as well as liquid raw materials except solvents are to be sampled in sampling booth.

Sampling: Raw Material Sampling and Release

[][]Receive the GRN for raw material from the warehouse then compare with Manufacture’s CoA and enter the details (GRN Received Date, GRN No., Lab. Control No., Name of material, Code No., Invoice/Challan No., Manufacturer Lot No., Manufactured by, Supplied by, Mfg. Date, Exp. Date, Qty. received, Received by & date) in the Raw Material Register (as per Annexure-I) maintained in QC department.
[][]If the Manufacture’s CoA is not received, inform to Supply Chain Department.
[][]Ensure that material is received from Approved Vendor.
[][]If the material is not from Approved Vendor, then the material is not to be sampled.
[][]Assign the work of sampling of the material to the QC Executive.
[][]Share the copy of GRN and Manufacturer CoA with Microbiology Laboratory, when required.
[][]Inform Warehouse to ensure cleanliness of sampling area and fill-up the Cleaning Checklist before Sampling of Raw Materials (Annexure-VIII) and then start-up of sampling booth.
[][]Assigned QC Executive will take required no. of “SAMPLED” label as per labeling SOP.
[][]Assigned QC Executive will prepare and checked ‘SAMPLING IN PROGRESS’ label (as per Annexure-II); prepare required containers/poly bags for sampling according to sampling plan for the material to be sampled.

Sampling plan

[][]In case of all active raw materials, carry out sampling from all containers in each of supplied batch for performing identification test individually for all the containers.
[][]In case of all excipient, carry out sampling from different containers in each of supplied batch according to formula √n + 1 e.g. for 10 containers sample from √10 + 1 = 4.16 ≈ 5 containers.

Sampling container

[][]Select the sample container according to the nature of the material to be sampled.
[][]Use clean fresh poly bags for solid materials.
[][]Use clean dry glass bottle with screw cap for liquid, dry amber glass bottle with screw cap for light sensitive liquid and transparent stoppered flask for solvents.
[][]Use sterilized screw capped conical flask (autoclaved at 121°C for 15 minutes) for sampling of raw material for microbial test.
[][]Sample all light sensitive solid materials in black polyethylene bag.
[][]Sample all the moisture sensitive materials in air tight container.

Sampling note: Raw Material Sampling and Release

Solid

If the material is in paper bag, take the sample by cutting a small ‘V’ on the bag and in case of Drum open the lid & inner polyethylene then push the Sampling thieve and take sample into a labeled poly-bag. Then place a clean poly-bag over the tear area and properly seal the poly-bag with adhesive tape. In case of Drum, tie the inner-polyethylene with rubber band/cable tie, finally twist the lid properly.

Liquid

Deep the liquid sampling device vertically into the sample drum and collect the sample or pipette after gently stirring the liquid and transfer the liquid sample to a labeled, cleaned container. Solvent in distorted metal drum must be sampled in addition to the rule of Ön + 1. Sample all flammable solvents in solvent dispensing room.

Sampling device

Use stainless steel sampling devices specially designed for solid and liquid material.

[][]For solid materials received in drums/container use specially designed S.S. sampling device by which material can be sampled from different level (thief sampler).
[][]For liquid and solvents received in drum, use specially designed S.S. drum sampler.
[][]For liquid material received in small container use specially designed small SS liquid sampler.
[][]For solid material received in bags use specially designed SS solid sampler/SS spoon.
[][]For microbiology analysis, use screw capped conical flask/glass bottle and SS spoon (autoclaved at 121°C for 15 minutes).
[][]Clean and maintain the sampling device (tools) as per SOP for cleaning and storage of sampling tools after completion of sampling.

Damaged containers or torn bags

[][]Check the physical condition and cleanliness of raw material containers before opening for sampling.
[][]If any container found in damaged condition, intimate warehouse in-charge.
[][]Damaged containers whose integrity is doubtful should be sampled and tested separately.
[][]Inform warehouse in-charge to take initiatives for repacking of damaged container or torn bags if necessary.

Gowning procedure

[][]Wear fresh gown before entering into sampling booth.
[][]Wear sterile gloves, mask before sampling for microbiology analysis.
[][]Cover the hands with gloves and wear a cap and mask to cover hair and nose respectively.
[][]Cover the footwear with shoe cover.
[][]Use separate apron, nose mask, hand gloves, cap & shoe covers for sampling of different material.
[][]Mop the hands with 70% IPA and air dry before proceeding for sampling and particularly when samples are to be drawn for Microbiological testing.

Sampling procedure

[][]Check the Cleaning Checklist before Sampling of Raw Material (as per Annexure-VIII).
[][]Inform Warehouse before going for sampling to arrange the raw material containers which are to be sampled in sampling booth area and ensure the cleanliness of these containers externally, before bringing the container to be sampled to the sampling area.
[][]Enter the Warehouse (Raw Material) with sampling basket, sampling utensils, sampled label, poly-bags, GRN and ‘Sampling in progress’ label.
[][]Check the details given on the GRN with the suppliers label and ensure that the “Quarantine” label affixed by the warehouse personnel on all raw material containers of a consignment.
[][]Select number of containers/ bags as per sampling plan and inform Warehouse personnel to send the raw material containers to the material entry airlock.
[][]Check that ‘CLEANED’ label is affixed to the sampling booth and then affix the ‘Sampling in-progress’ label outside of the sampling booth. Enter the sampling booth.

Operate the sampling booth

[][]Receive the desired container(s) within material entry airlock. Check that the containers are free from dirt & dust externally. Do not sample the container/bag whose packing integrity has been lost (material has been exposed to environment).
[][]Take the raw material inside the sampling booth. Sample in a manner so that laminar airflow can be in operation without any interruption.
[][]Enter the information about the material sampled into the ‘Sampling Register’ i.e. Date, GRN No., Lab. Control No., Name of material, Code No., Manufacturer Lot no., Manufactured by, Sampling start time (as per Annexure-IV).
[][]Wear disposable hand gloves just before start of sampling.
[][]Open the container for sampling one by one.
[][]Check the physical condition of the raw material for any gross abnormalities like dis-colourisation, lumps, foreign matter and physical heterogeneity. Record information in Raw Materials Sampling Report (as per Annexure-V).
[][]Collect the sample aseptically into sterile screw capped conical flask by sterilized sampling device for microbiology analysis.
[][]Assign the sampled Container No. as 1/25, 2/25, 13/25, 25/25 etc. with Reference to drum number of container sampled.
[][]Draw the sample from different levels of the container. (i.e. From Top, Middle & Bottom). The weight of the total sampled quantity should be according to List of Raw Material Sampling Quantity (prepared as per Annexure-III).
[][]For excipient, prepare composite sample by taking equal quantity of material from the sampled drum. Mix thoroughly in big polythene bag for retained sample and testing sample. For identification test take individual small quantity of sample from each sampled container.
[][]For active raw material, prepare composite sample during sampling for assay for every 10 containers of the consignment by taking equal quantity of material from individual sampled container. Mix thoroughly in plastic bag to make sample for assay test. For complete analysis (except identification and assay) and retention sample make composite sample by taking equal quantity from all bags or container during sampling. For identification test take individual small quantity of sample from each container.
[][]Take the individual sample from each sampled container for microbiological analysis in sterile container, if specified.

Reseal the container properly after sampling as follows: Raw Material Sampling and Release

[][]Fibre/Plastic container pack: Shrink the inside poly bag by twisting it sufficiently. Bent it & tie it using cable tie. Place the lid of container & close it tightly & seal it.
[][]Woven and Paper Bag: Close the sampling point and seal it properly using BOPP tape.
[][]Liquid RM container: Place the lid of container & keep it tightly closed.
[][]Affix yellow colour duly filled & signed ‘SAMPLED’ label on each containers from which the samples are collected and ‘UNDER TEST’ label on all containers of a consignment.
[][]After completion of sampling switch off the sampling booth.
[][]Record sampling details in Raw Materials Sampling Report (as per Annexure-V).
[][]Enter the Sampling end time, Sampled quantity, Sampled by and Remarks (if any) into the ‘Raw Material Sampling Register’ (as per Annexure-IV).
[][]Place the used sampling device in container labeled as ‘TO BE CLEANED’ containing a poly bag.
[][]Shift sampled container outside the sampling booth.
[][]Inform warehouse personnel to transfer it to quarantine area.
[][]Leave sampling booth and affix ‘TO BE CLEANED’ label outside the sampling booth. Inform warehouse personnel for cleaning.
[][]Warehouse personnel will clean the sampling booth, enter the sampling booth cleaned by in ‘Raw Material Sampling Register’ (as per Annexure-IV) and then affix ‘CLEANED’ label outside the sampling booth.
[][]If any discrepancy found, immediately inform the warehouse in-charge.
[][]Keep the collected samples in the sample receiving room of QC Laboratory in dedicated rack for Raw Material or in refrigerator, if specified.
[][]Keep the retention sample in retention sample room or in refrigerator, if specified.
[][]Enter the sampled by (initial) and date in the ‘Raw Material Log Register’ (as per Annexure-I).

Release:

[][]Enter the sampled by (initial) and date in the ‘Raw Material Log Register’ (as per Annexure-I).
Issue the Raw Material Analytical Work Sheet (as per Annexure-VI) (for commercial raw material) with initial and date on every sheet to the analyst and enter the worksheet issued by (initial and date) in the ‘Raw Material Log Register’ (as per Annexure-I).
[][]Carry out the physical appearance and identification test separately for active raw material from each container.
[][]Microbiology will perform microbial limit test from all sampled container and bacterial endotoxins test from composite sample.
[][]Perform identification test of excipient from all sampled containers.
[][]For active raw materials, prepare sub-composite sample from each 10 container and then prepare composite sample from all the sub-composite samples. Perform the test of sub-composite sample if composite sample shows out of specification result to identify easily which container(s) is in problem. Retain all the sub-composite samples until release of the material.
[][]For active raw materials perform rest of the test as per the specification from the composite sample prepared from all containers. Carry out assay test from the composite sample and take result.
[][]For excipient perform the complete test as per specification from the composite sample prepared from the sampled containers.
[][]Check the appearance of capsule shell according to Sampling Plan for Normal Inspection of Capsule Shell (as per Annexure-IX).
[][]Test all parameters according to the Raw Material Specification and analyze the batch exactly as written in the method of analysis.
[][]Record all analytical raw data and calculations, and attach the printout of weight(s) in the analyst logbook.
[][]Fill up the Raw Material Analytical Work Sheet (as per Annexure-VI) and attach printout of required raw data.
[][]Weigh the sample ± 5.0% of specified quantity for assay test and ±10.0% of specified quantity for all other tests.
[][]Use bracket like [ ] to indicate that the result is taken from manufacturer’s/supplier’s certificate of analysis (CoA) (if available).
[][]Entry all data in previously created certificate of analysis for raw materials in ERP (as per Annexure-VII).
[][]Verify the test report with specification followed by Approval/Rejection in ERP.
[][]Follow SOP for handling of out of specification if the test result does not comply with the specification.
[][]After approval/rejection print out the COA and two copies of GRN under the heading of

Approved/Rejected quantity.
Date of Release/Rejected.
Approved/Rejected status.

[][]Submit all report to QC Manager for approval.
[][]Submit one copy of GRN with the initial with date of In-Charge, QC or his/her designee to store.
[][]Compile a bunch with CoA (as per Annexure-VII), filled Raw Material Analytical Work Sheet (as per Annexure-VI) and raw data, Raw Materials Sampling Report (as per Annexure-V), QC copy of GRN after approval.
[][]Fill up the Trend Card with necessary data.
[][]Prepare the required number of green “PASSED” label for passed.
[][]In case of Rejection, prepare the required no. of red “REJECTED” label.
[][]Fill up the Raw Material Rejection Form (as per Annexure-X) for rejection of raw material.
[][]Paste “PASSED”/“REJECTED” label in cascading manner (overlapping upto ³/₄ th of the status bar of the previous label) over the “UNDER TEST” label without hiding any information of the previous label.

List of Annexes: Raw Material Sampling and Release

Raw Material Sampling and Release Standard Procedure Read More »

Sampling Tools Cleaning and Storage SOP

Quality Control, SOPs

Sampling Tools Cleaning and Storage; Purpose:

Sampling Tools Cleaning and Storage; The purpose of this procedure is to describe the instruction of cleaning and storage of sampling tools.

Sampling Tools Scope:

This SOP is applicable to sampling tools used for Quality Control Laboratory and Microbiology Laboratory at XX Pharmaceuticals Ltd.

Definitions/Abbreviation:

[][]SOP: Standard Operating Procedure: A written authorized procedure, which gives instructions for performing operations.
[][]QC: Quality Control.

Responsibilities:

[][]The roles and responsibility is as follows:
[][]Laboratory Attendant, QC & Microbiology
[][]To prepare of cleaning solution.
[][]To clean and store all sampling tools by following SOP.
[][]Executive, QC & Microbiology
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.

Manager, Quality Control

[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]Arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.
[][]Schedule calibration of the instrument at the defined intervals.

Head of Quality Assurance

[][]Approval of the SOP.
[][]To ensure overall implementation of this SOP.

Procedure:

Precaution(s):
[][]Wear hand gloves, mask and protective clothing before cleaning of sampling tools.
[][]Be sure that the sampling tools are cleaned just after use.
[][]After cleaning of tools, be sure that the tools are free from any residual content of detergent or sample.
[][]During handling, sterilized gloves should be worn after sterilization of microbiology sampling tools.
Cleaning of Sampling Tools:

For scoop/spoon:

[][]Clean the sampling devices with potable water following by 0.5% soap or detergent solution.
[][]Finally rinse with purified water to remove the adhering material.
[][]Check the cleanliness physically and clean again if necessary.
[][]Dry in hot air oven for use in QC sampling.
[][]Sterilize at 2000C for 1 hour or autoclave at 1210C for 15 minutes for the sampling of Microbiology analysis.

For pipette (glass) and Glass Rods:

[][]Pass the running potable water through the pipette to remove the adhering material.
[][]Sink the pipette into 0.5% soap or detergent solution.
[][]Rinse with potable water to remove detergent.
[][]Finally rinse with purified water.
[][]Confirm that the tools are cleaned properly, clean again if it is necessary.
[][]Dry in hot air oven for use in QC sampling.
[][]Sterilize at 2000C for 1 hour or autoclave at 1210C for 15 minutes for the sampling of Microbiology.

Storage of Sampling Tools:

[][]After dry, remove the cleaned tools from the oven and wrap the dry tools individually with cleaned polybag.
[][]Ensure that there is no exposure of sampling tools after wrapping the cleaned dried tools with polybag.
[][]Finally keep it at closed condition.
[][]Affix the tag “CLEANED” label duly signed with date on the sampling tools.
[][]Use the tools within 7 days sampling of Chemical test and within 24 hours for sampling of microbiology test.

Sampling Tools Cleaning and Storage SOP Read More »

Sampling Booth Start-up, Operation and Cleaning

Quality Control, SOPs

Sampling booth Purpose:

The purpose of this SOP is to describe the operation and cleaning procedure of Sampling Booth in order to comply with cGMP standard.

Sampling booth Scope :
The scope of the procedure is applicable to the Sampling Booth installed at the Warehouse of general block of XX Pharmaceuticals Limited.

Definitions/Abbreviation:

[][]SOP: Standard Operating Procedure
[][]QC: Quality Control

Responsibilities:

The Roles and Responsibilities are as follows:

Officer/Executive/Sr. Executive, Quality Control

[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.

Executive, Warehouse

[][]To ensure that this procedure is followed.
[][]To check & ensure cleaning of sampling booth.

Manager, Quality Control

[][]To confirm that the SOP is technically sound and reflect the required working practice.
[][]To arrange the training on the SOP to all concerned personnel and to ensure the implementation of the SOP after training.

Head of Quality Assurance

[][]To approve the Document
[][]To ensure the overall implementation of the SOP.

Procedure

Precautions:
[][]The working person must follow safety procedures of works.
[][]For any trouble, disturbance switch OFF the Sampling Booth.
[][]Don’t sampling solvent and flammable liquid inside the sampling booth

Operation

[][]Check the Sampling Booth first physically.
[][]Check electric connection and mechanical set up.
[][]Machine switch on.
[][]Light on and blower on.
[][]Open the door.
[][]After completion desired work clean the Laminar Unit properly.
[][]Close the door and switch off main switch.
[][]Switch ON Sampling Booth.
[][]Switch ON Light.
[][]Switch ON the Laminar Air Flow.
[][]Increase or decrease air flow by pressing up/down button.
[][]Operate the Sampling Booth for 30 minutes before starting sampling.
[][]Record the machine operation start time & end time and other parameters on the Equipment Log Book’

Cleaning

[][]Remove dust from the Sampling Booth with a vacuum cleaner and then clean with lint free cloth.
[][]Clean the booth with wet mop.
[][]Wipe the water with lint free cloth.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning status in the ‘Equipment Log Book’.

Download Here:

[][]Annexure I: Equipment Log Book

Sampling Booth Start-up, Operation and Cleaning Read More »

Assigning of laboratory control number for different items

Quality Control, SOPs

Assigning of laboratory control number; Purpose

The tenacity of this SOP is to define the procedure of assigning Laboratory control number (Lab. Control No.) of all type raw material, packaging material, water, intermediate, bulk and finished product that are analyzed in Quality Control and Microbiology Laboratory.

Assigning of laboratory control number; Scope

This procedure is applicable for all type of raw materials, packaging materials, water, intermediate, bulk and finished products of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[] GRN: Goods Received Note

[] Lab. Control No.: A system of alpha-numerical number which represents request for analysis of materials/ water/ products received from respective department.

[] QC: Quality Control.

[] SAF: Sampling Advice Form

Responsibilities

The roles and responsibility is as follows:

[] Sr. Executive/Executive, Quality Control & Microbiology

[] To confirm that this procedure is followed.

[] To maintain the records properly as per SOP.

Assistant Manager, Quality Control

[] To confirm that this procedure is kept up to date.

[] To check that the SOP reflects the required working practices.

[] Organize training on the SOP to all concerned personnel.

[] To confirm implementation of the SOP after training.

Head of Quality Assurance

[] To ensure the overall implementation of the SOP.

[] Take initiative to Approval of the SOP.

Procedure:

[] All newly delivered samples & the accompanying documents (e.g. test request) must be assigned a separate registration number.

[] Assign Laboratory control number (Lab. Control No.) in following way:

Put first two or three letters according to the abbreviations mentioned below –

BBW Boiler Blowdown Water
BFW Boiler Feed Water
CTW Cooling Tower Water
DW Drinking Water
EM Environment Monitoring
ET Endotoxin Test
ETP Effluent Treatment Water
FP Bulk Product (Semi-Finished)
GMB General Microbiology
PM Packaging Material
PMS Packaging Material of Source Approval
PSC Purified Steam Condensate
PTW Potable Water
PW Purified Water
RM Raw Material
RMS Raw Material of Source Approval
SHC Sodium Hypochlorite
ST Sterility Test
STB Stability Sample
WFI Water for Injection
WW Wash Water

Write down a hyphen (-) after the abbreviation, then serial number consist of three digits i.e. 001, then a slash and put two digits of month i.e. 08 for month August.

Again write down a slash (/) then last two digits of the year i.e. XX for year 20XX. For example, first raw material received on August 20XX will get the Lab. Control No.: RM-001/08/XX.

GMB will be included before abbreviation of each test in case of microbiology lab control no./lab reference no. and put slash (/) after that.

Record Lab. Control No. in Register against each GRN / SAF.

Record the same in respective documents and status label also.

Assigning of laboratory control number for different items Read More »