SOP of GOOD LABORATORIES PRACTICE

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
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.