This document details the Good Laboratory Procedures(GLP) in Pharmaceuticals. The analysis shall be carried out according to the documented procedures/specifications. Analysts shall not change documented methods.
2.0Â Â RESPONSIBILITY
|
S. No |
Designation |
Responsibility |
|
01 |
Executive – Corporate Quality Assurance |
Preparation of SOP for Good laboratory practices  |
|
02 |
Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst |
To follow the SOP accordingly |
|
03 |
Manager – Quality Control |
Implementation of the SOP. |
|
04 |
Manager – Quality Assurance |
Implementation of the SOP |
|
05 |
Manager – Corporate Quality Assurance |
To ensure implementation of SOP. |
PROCEDURE
2.1Â Â laboratory
discipline
2.1.1Â All the
employees shall follow the dress code within the laboratory.2.1.2Â Analysis shall be carried out according to the documented procedures/specifications. Analysts shall not change documented methods unless the changes are duly authorized.
2.1.3Â Record all the observations and calculations on the test protocol. An extra calculation sheet can be attached wherever possible. COA (Certificate of Analysis) shall be generated with the use of computers in a similar manner.
2.1.4Â Â Wrong entries shall be corrected as per SOP Good Documentation Practices.
2.1.5 Every analysis shall carry the date on which it is carried out. Spectra, chromatograms, and other test records shall be attached to the Analytical Report and filed.
2.1.6Â All reagent bottles/chemicals shall be properly labeled and stored in the identified areas or shelves.
2.1.7Â Labels shall indicate the date on which the reagents were opened/prepared or standardized.
2.1.8Â Â Spoiled and disfigured labels shall be replaced.
2.1.9Â Labels that are not current shall be peeled off or covered with the next label (cross the previous label), whenever a solution is changed or freshly standardized and kept in respective shelves.
2.1.10Â Â Laboratory shall be maintained in a clean and orderly manner at all times.
2.1.11Â Â Care shall be taken
that instruments shall be switched off if they are not in use (except IR).
2.2Â Â LABORATORY
SAFETY
2.2.1Â Â Follow the
SOPÂ Laboratory Safety, in order to ensure personal safety.
2.3Â Â CLEANING
OF LABORATORY GLASSWARE
2.3.1Â Follow the
SOPÂ Cleaning of Glassware, in order to ensure the right analysis results.
2.4Â Â VOLUMETRIC
SOLUTION AND REAGENT
2.4.1Â Â Preparation of Volumetric solutions shall be done as per SOP Preparation and Standardization
of Volumetric solutions.2.4.2Â Â Â Prepare the volumetric solution according to the individual test procedure.
2.4.3Â Â Store these in bottles with labels indicating the name of the solution, its strength, date of preparation the person who has prepared it, etc, as per SOP Labeling Policy.
2.4.4Â Standardize these solutions after preparation on the predetermined schedule whenever required.
2.4.5  Record the calculations, weights, weight slips, and normality’s on the specified formats.
2.4.6Â Â before using check visually that the contents of the bottle are clear.
2.4.7Â Â Volumetric
solutions shall not differ from the prescribed strength by more than 5 percent.
Where the strength falls below 5 percent the solution shall be replaced.
2.5Â Â ANALYTICAL REFERENCE NUMBER
2.5.1Â All samples analyzed in the laboratory shall have a unique analytical reference number as per SOP Report No.
2.5.2Â Â Analytical Reference Numbers are assigned in registers or by software for samples of raw material, intermediates, packaging materials, and finished products.
2.5.3  Record the details of sample in the specified register having details like Sr. No., Date of receipt, Batch Number, MRN No., (Wherever Applicable), AR No. (Analytical Reference Number), Analyzed by, Status (Approved / Rejected) with date, etc.
2.6Â Â Analytical Reference Substances and Working Standards
2.6.1Â Â Reference Substances or Reference Standards are authentic samples of highly purified chemicals supplied by the official Pharmacopoeia Commissions. These are used as a basis of comparison for determining the purity of the test specimen.
2.6.2Â As these are available only in small quantities, Working Standards are prepared to act as substitutes. These are prepared from in-house manufacture material and standardized against authentic Reference Substances or authentic working standards.2.6.3Â Â Reference Standard:
2.6.3.1Â after receiving the Reference Substance, enter the details of the substance in the log meant for the purpose.
2.6.3.2Â Store it in an air-conditioned room/refrigerator/mentioned on the label and use it as directed on the label.
2.6.3.3Â Whenever official standards get changed by Pharmacopoeia Commissions, replace the old Reference Substances with the current Reference Standards.
2.6.3.4Â Each Reference Substances shall have a code number with prefix RS.
2.6.4Â Â Â Â Â Working Standards
2.6.4.1 Choose and standardize the purest possible material matching with the Reference Substance in purity and in other standards. Working Standard shall have high purity and least possible related impuritiesÂ
2.6.4.2Â After standardization against the Reference Substance or existing Working Standard, enter the details like date of standardization, purity standards, and date till which it is valid in the log, working standard protocol, and label.
2.6.5Â Â Â Â Â Store in an air-conditioned room/refrigerator after labeling appropriately, as per SOPÂ Labeling Policy.
2.7Â Â Sampling
2.7.1Â Â sampling of raw material, packing material, bulk, intermediate, and finished goods shall be carried out as per the written procedures.
2.8   General Procedure for Analysis (For production)
2.8.1     Intimations shall be sent by the respective department to Quality Control when any analysis is required.
2.8.2Â Â Â Â Â When a consignment of raw materials is received by Stores, intimation is sent to Quality Control Department on an MRN (Material Receipt Note).
2.8.3Â Â Â Â Â After receiving the MRN make entries in the relevant register assigning an A.R. Number to each batch.
2.8.4Â Â Â Â Â Collect samples of the material from the warehouse affix Quarantine / Under Test labels on the containers and keep these samples at the designated place.
2.8.5Â Â Â Â Â Refer to the sampling checklist for the individual items.
2.8.5.1Â Check the individual samples for their physical uniformity e.g. color, nature, appearance, etc. as per the format of the SOP for a sampling of raw materials.
2.8.5.2Â If they pass the preliminary examination, pool these together to form a composite sample.
2.8.5.3 Withdraw a quantity from the composite sample to keep as ‘Retained Sample’ as per the SOP for a sampling of raw materials.
2.8.5.4Â Carry out the analysis as per the specifications and test method and follow the individual test protocol.
2.8.5.5Â All the glassware used for testing/dilutions shall be labeled accordingly having information like product/material name, batch no., with signature and date.
2.8.5.6Â All the executed test protocols shall be cross-checked and signed by the reviewer.
2.8.5.7Â Indicate on the COA (Certificate of Analysis) whether the same complies with its specification or not.
2.8.5.8Â After completion of the analysis, all the glassware shall be placed in the specified SS tray and all the accessories used during analysis shall be placed in specified drawers.Â
2.8.5.9Â In case any material is found out of specification, the same shall be handed as per SOP Handling of out of Specification Results.
2.8.5.10 Prepare the ‘Approved’ or ‘Rejected’ labels and get these affixed under your supervision of quality control personnel.
2.8.5.11Â Retain the Analytical Report.
2.8.5.12Â when a material has to be retested for any reason, Quarantine / Under Test labels shall be affixed by the warehouse personnel at the side of the previous affixed labels.
2.8.5.13Â Cross the previous labels by using the black marker pen.
2.8.5.14 Sampling and re-analysis shall be done and issue the fresh ‘Approved/ Rejected‘ labels.
2.9Â Â Â Â Â Â Â Â Â Â General Procedure for Analysis (For Analytical division)
2.9.1     Intimations shall be sent by the respective department to Quality Control when any analysis is required.
2.9.2Â Â Â Â Â After receiving the sample make entries in the relevant register/software assigning an A.R. Number to each sample.
2.9.2.1Â Check the individual samples for their physical uniformity e.g. color, nature, appearance, etc.
2.9.2.2Â If they pass the preliminary examination, pool these together to form a composite sample.
2.9.2.3 Withdraw a quantity from the composite sample to keep as ‘Retained Sample’.
2.9.2.4Â Carry out the analysis as per the specifications and test method and follow the individual test protocol.
2.9.2.5Â All the glassware used for testing/dilutions shall be labeled accordingly having information like product/material name, batch no., with signature and date.
2.9.2.6Â All the executed test protocols shall be cross-checked and signed by the reviewer.
2.9.2.7Â Indicate on the COA (Certificate of Analysis) whether the same complies with its specification or not.
2.9.2.8Â After completion of the analysis, all the glassware shall be placed in the specified tray and all the accessories used during analysis shall be placed in specified drawers.Â
2.9.2.9Â In case any material is found out of specification, the same shall be handed as per SOP Handling of out of Specification Results.
2.9.2.10Â Retain the Analytical Report.
2.10Â Â Â Â Â Â Â EXTERNAL
ANALYSISÂ / SUBCONTRACTING
2.10.1Â Â Â Sometimes material
is tested at another Unit or an outside laboratory due to non-availability of
equipment, facility, or for confirmation of results.2.10.2Â Â Â Send the sample to an authorized testing laboratory.
2.10.2.1Â Procedure shall be followed as per SOP Handling of External Analysis.
2.11Â Â Â Â Â Â Â RETAIN
SAMPLE
2.11.1Â Â Â Retain samples
shall be treated as per SOP Storage and Withdrawal of
Retain Samples2.11.2Â Â Â Destruction of retain samples shall be done as per SOP Destruction of Retain Samples
2.12Â Â Â Â Â Â Â Stability Studies
2.12.1Â Â Â Stability studies shall be done as per SOP Stability of Finished Products
2.13Â Â Â Â Â Â Â Laboratory Documentation
2.13.1   Documentation is a prime necessity in Quality Assurance. It serves to define systems of control, reduce the risks of error inherent in oral communication, and to ensure that personnel are instructed in the details and follow procedures. It also helps in tracing the history of each batch of products from the stage of receipt of materials to the release of the batch to the market.
2.13.2Â Â Â In the analytical laboratory the important aspects of Quality Control documentation are:
2.13.2.1Â Â All the documents shall bear an effective date, code number and history of version control shall be maintained.
2.13.2.2Â Follow the change control procedure in advance for any amendment of the document before the scheduled revision time period
2.13.2.3Â Where the amendment is permanent, replace the amended document with a newly prepared document.
2.13.2.4 Remove the superseded document from active use, after stamping it as ‘Superseded’ for reference.
2.13.2.5Â Keep all the records neat and clean.
2.13.2.6Â All the specifications and test methods,
reference books/documents shall be placed at the specified place after
completion of the analysis.
2.14Â Â Â Â Â Â Â EQUIPMENT
OPERATING PROCEDURES
2.14.1Â Â Â Standard Operating Procedures and Calibration Procedure shall be available for all the
instruments.2.14.2Â Â Â Keep these at a
place for ready reference and operate the instrument only when you have
understood the procedure.
2.15Â Â CALIBRATION AND MAINTENANCE OF INSTRUMENTS
2.15.1Â Â Â Procedures for maintenance, calibration of the instrument, and schedules shall be prepared and maintained in the laboratory.
2.15.2   Calibrate the instruments according to the procedure schedule periodically and maintain the record for each instrumentÂIt is the policy of Pharmaceuticals Ltd that the
written procedure shall be followed in the laboratory as per good
laboratory practices
This procedure is to be applied at any time in the
laboratory.
