Amendment status not verified — confirm the current text below against the official source.
Standard Operating Procedures:- (a) Standard Operating Procedures are written procedures for different activities being conducted in a laboratory and shall include the following characteristics: (i) they shall be written in a chronological order listing different steps leading to an analysis of drugs or calibration of an instrument: (ii) testing laboratories shall have Standard Operating Procedure manuals and have its periodic review; (iii) it shall be user friendly documents and shall include designation of the person responsible for intended activity. (b) Standard Operating Procedures in addition to those recommended under various activities shall also be prepared to the minimum in respect of the following: (i) sample handling and accountability; (ii) receipt identification, storage, mixing and method sampling of the test and control articles; (iii) record keeping, reporting, storage and retrieval of data; (iv) coding of different studies, handling of data including use of computerized data system; (v) operation of technical audit personnel in performing and reporting audits, inspections and final report reviews; (vi) routine inspection of cleaning, maintenance, testing, calibration and standardisation of instruments; (vii) action to be taken in respect of equipment failure; (viii) analytical data methods; (ix) the raw data; (x) data handling and storage retrieval; (xi) health and safety protection; (xii) animal room preparations; (xiii) animal care; (xiv) storage and maintenance of microbial cultures; (xv) maintenance of sterility room (i.e. constant maintenance and monitoring of Aseptic condition of sterility room); (xvi) use and storage of reference standards; (xvii) procurement of stores and equipment; (xviii) monitoring of testing of samples; (xix) method of retention of unexpended samples, their location, maintenance and disposal; (xx) document control; (xxi) redressal of technical complaints; (xxii) housing-keeping; (xxiii) corrective and preventing action; (xxiv) working procedure (test methods); (xxv) calibration Manual; and (xxvi) training manual.