Equipment: (i) brief description of major producti...

Equipment: (i) brief description of major production and quality control laboratories equipment (a list of the equipment is required); (ii) maintenance (description of planned preventive maintenance programmes and recording system); (iii) qualification and calibration, including the recording system. Arrangements for computerized systems validation. 5. Sanitation: Availability of written specifications and procedures for cleaning the manufacturing areas and equipment. 6. Production: (i) brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters; (ii) arrangements for the handling of starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and storage; (iii) arrangements for reprocessing or rework; (iv) arrangements for the handling of rejected materials and products; (v) brief description of general policy for process validation; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 103 of 248 (vi) brief description of sterilisation facility.