SOLITAIRE PHARMACIA PVT. LTD.
1. Objective
To define the procedure for Good Laboratories Practice.
2. Scope
This procedure is applicable to Quality Control department at Solitaire Pharmacia Pvt. Ltd., Baddi.
3. Responsibility
Officer or above –Quality Control
4. Accountability
Head- Quality Control
5. Procedure
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5.1 Premises: Laboratory should be located designed, customized and maintained to suit the performance of all Q.C. test and analysis required.
5.1.1 Conveniently located to service the Mfg. Dept. but preferably separate to avoid vibration, dust, internal and external traffic to protect the delicate instruments.
5.1.2 As far as possible there must be separate wings for analytical, instruments and microbiology etc. and all wings may be inter connected with internal door.
5.1.3 There must be effective air lock, provisions for A.C. and 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.
5.1.4 Laboratory furniture so designed to provide for adaptability, table top must be covered properly resistant to acid, alkali and solvent etc. Floor should be smooth, easy to clean and adequate drainage facility.
5.2 Equipment’s:
5.2.1 There must be a written standard operating procedure for each instrument. Instrument should be located with 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.
5.2.2 The calibration and maintenance / service record must be kept and must be done periodically.
5.2.3 The glassware must be calibrated with certified one before use. Particularly the glassware which are suppose 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.
5.2.4 Light should be adequate.
5.2.5 Electrical system in laboratory must not be over loaded. Voltage stabilizer must be provided to protect delicate instruments.
5.3 Chemicals and Reagents: Storage of chemicals and reagent should be done in a manner it involved in the use, container of all chemicals and reagents must be properly labeled. Transfer of chemical must be done almost care. All analytical reagents and prepared solution must be labeled. Records of Molar Solutions entered in register prepared for the same. “No chemical reagents pipettes out by mouth, rubber bulb must be use.”
5.3.1 Every individual who is a part of the laboratory and engaged in conduct of testing shall have the requisite educational qualification, training, and experience to enable the individual to perform the assigned function.
5.3.2 There shall be sufficient and number of personnel for proper conduct of the studies in accordance with protocols.
5.3.3 The personnel should take adequate precautions to avoid contamination of test and control article of the test systems.
5.3.4 The personnel should be provided with appropriate clothing suiting to their needs and the clothing should be of a nature, which will prevent microbiological, chemical contamination.
5.3.5 The personnel should be subjected to proper medical examination to ensure that there will not be a source of contamination and their health status.
5.3.6 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 a nature, which will prevent microbiological, chemical contamination.
5.3.7 There should be a defined organogram of the laboratory and responsibility and duties at various levels should be well defined and documented.
5.4 Documentation: The document is 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 are routinely recorded in a laboratory:
· Receipt and storage of samples
· Sampling
· Analytical testing
· Validation
· Calibration
· Data recording
· Operation of instruments
· Reagent preparation
· Training Records
· Sampling Procedure
· Analytical testing methodology.
· Supplies inventory/list.
· Instrument calibration Data.
· Methods validation data.
· Analytical testing results and reporting.
5.5 Quality Control:
There must be a well-defined procedure, which cover 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 sample is permitted, how many can be blended together etc.
5.6 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.
5.7 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 authorization person and these records are preferably stored under lock and key.
5.8 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 incase of accidental part.
5.9 Auditing Procedure: The quality Assurance Department of the laboratory should constitute a committee who has to regularly audit their facilities to ensure complies to GLP requirement.
6. Records/Formats:
NA
7. Annexure:
NA
8. Reference:
Schedule L-1
9. Abbreviations:
SPL - Solitaire Pharmacia Pvt. Ltd., Baddi.
QC - Quality Control
SOP - Standard Operating Procedure
10. Revision History:
Revision No / Effective date / Reason for Revision00 / New Document