Good Laboratories Practice (GLP) in Pharmaceuticals

In pharmaceutical laboratories, GLP should be followed. Following are the main points those should be considered under GLP.

• The laboratory should be located designed, customized and maintained to suit the performance of all Q.C. test and analysis required.
• Conveniently located to service the Mfg. Dept. but preferably separate to avoid vibration, dust, internal and external traffic to protect the delicate instruments.
• As far as possible there must be separate wings for analytical, instruments, microbiology and sterility etc. and all wings may be interconnected with the internal door.
• There must be an effective airlock, provisions for A.C. and fumigation chamber, the laboratory should be so designed that not only adequate provision of space but provision for utility, water, solvent storage, extraction dust collection etc. were covered.
• Laboratory furniture so designed to provide for adaptability, tabletop must be covered properly resistant to acid, alkali and solvent etc. The floor should be smooth, easy to clean and adequate drainage facility.

Equipment

• There must be a written standard operating procedure for each instrument. The instrument should be located with an adequate place in a separate room under controlled temperature, Instrument must be handle with almost care and keep it clean all the times. The surrounding also required to be cleaned.
• The calibration and maintenance/ service record must be kept and must be done periodically.
• The glassware must be calibrated with certified one before use. Particularly the glassware which is supposed to be utilized for measuring purpose must need calibration before use. All the necessary instruction regarding operating, handling and care should be display near the instruments.
• The light should be adequate.
• The electrical system in the laboratory must not be overloaded. Voltage stabilizer must be provided to protect delicate instruments.

Chemicals and Reagents

• Storage of chemicals and reagent should be done in a manner it involved in the use, the container of all chemicals and reagents must be properly labeled. Transfer of chemical must be done almost care. All analytical reagents and a prepared solution must be labeled. Records of Molar Solutions entered in the register prepared for the same.
• “No chemical reagents pipettes out by mouth, rubber bulb must be used.”

Organization and Personnel

• Every individual who is a part of the laboratory and engaged in the conduct of testing shall have the requisite educational qualification, training, and experience to enable the individual to perform the assigned function.
• There shall be sufficient and a number of personnel for the proper conduct of the studies in accordance with protocols.
• The personnel should take adequate precautions to avoid contamination of test and control article of the test systems.
• The personnel should be provided with appropriate clothing suiting to their needs and the clothing should be of nature, which will prevent microbiologically chemical contamination.
• The personnel should be subjected to proper medical examination to ensure that there will not be a source of contamination and their health status.
• There should be a defined organogram of the laboratory and responsibility and duties at various levels should be well defined and documented. The personnel should be provided with appropriate clothing suiting to their needs and the clothing should be of nature, which will prevent microbiologically chemical contamination.
• There should be a defined organogram of the laboratory and responsibility and duties at various levels should be well defined and documented.

Documentation

• The document is a critical factor of the good laboratory Practice Documentation is the accepted method of recording information for future reference. The major documents that need to be provided are protocols, logbook for usage, maintenance and calibration of equipment there should be well established SOPs. The following are some of the information that is routinely recorded in a laboratory:
• Receipt and storage of samples

- Sampling
- Analytical testing
- Validation
- Calibration
- Data recording
- Operation of instruments
- Reagent preparation
- Training Records
- Organizational charts
- Sampling Procedure
- Analytical testing methodology
- inventory/list
- Instrument calibration Data
- Methods validation data
- Analytical testing results and reporting.

Quality Control

• There must be a well-defined procedure, which covers all the aspects pertaining to the sample i.e. receipt of the consignment, sampling techniques to be adopted, storage and handling of samples recording and reporting of analysis. Every sample that is received must have a distinctive number, which should appear on the label of the sample and should be stored in the prescribed conditions.
• There must be a well-defined sampling procedure in place, which should categorically specify in details the sampling procedure. If the blending of the sample is permitted, how many can be blended together etc.

Protocols and conduct of a laboratory test

Each laboratory should develop a well –defined protocol to carry out the test and the protocol should categorically mention.

Records and reports

Every laboratory should maintain records of all the tests performed any of the graphs pertaining to IR, HPLC, etc should be stored along with the raw data. For a quick reference, the access to records should be restricted to an authorized person and these records are preferably stored under lock and key.

Safety

There should be adequate facilities and accessories to provide safety for personnel involved in drug testing, required anti dose for possible accidents that occur, suitable equipment for fire extinguishing in case of an accidental part.

Auditing Procedure

The quality Assurance Department of the laboratory should constitute a committee who has to regularly audit their facilities to ensure compliance with GLP requirement.

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