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Quality Control System. - Quality control shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are actually carried and that the materials are not released for use, nor products released for sale or supply until their quality has been judged to be satisfactory. It is not confined to laboratory operations but shall be involved in all decisions concerning the quality of the product. It shall be ensured that all quality control arrangements are effectively and reliably carried out.The department as a whole shall have other duties such as to establish, evaluate, validate and implement all Quality Control Procedures and methods. 16.1 Every manufacturing establishment shall establish its own quality control laboratory manned by qualified and experienced staff. 16.2 The area of the quality control laboratory may be divided into Chemical, Instrumentation, Microbiological and Biological testing. 16.3 Adequate area having the required storage conditions shall be provided for keeping reference samples. The quality control department shall evaluate, maintain and store reference samples. 16.4 Standard operating procedures shall be available for sampling, inspecting and testing of raw materials, intermediate bulk finished products and packing materials and, wherever necessary, for monitoring environmental conditions. 16.5 There shall be authorized and dt. specifications for all materials, products, reagents and solvents including test of identity, content, purity and quality. These shall include specifications for water, solvents and reagents used in analysis. 16.6 No batch of the product shall be released for sale or supply until it has been certified by the authorized person(s) that it is in accordance with the requirements of the standards laid down. 16.7 Reference/retained samples from each batch of the products manufactured shall be maintained in quantity which is at least twice the quantity of the drug required to conduct all the tests, except sterility and pyrogen/Bacterial Endotoxin Test performed on the active material and the product manufactured. The retained product shall be kept in its final pack or simulated pack for a period of three months after the date of expiry. Drugs and Cosmetics Rules, 1945 397 16.8 Assessment of records pertaining to finished products shall include all relevant factors, including the production conditions, the results of in-process testing, the manufacturing (including packaging) documentation, compliance with the specification for the finished product, and an examination of the finished pack. Assessment records should be signed by the in-charge of production and countersigned by the authorised quality control personnel before a product is released for sale or distribution. 16.9 Quality control personnel shall have access to production areas for sampling and investigation, as appropriate. 16.10 The quality control department shall conduct stability studies of the products to ensure and assign their shell life at the prescribed conditions of storage. All records of such studies shall be maintained. 16.11 The in-charge of Quality Assurance shall investigate all product complaints and records thereof shall be maintained. 16.12 All instruments shall be calibrated and testing procedures validt. before these are adopted for routine testing. Periodical calibration of instrument and validation of procedures shall be carried out. 16.13 Each specification for raw materials, intermediates, final products, and packing materials shall be approved and maintained by the Quality Control Department. Periodic revisions of the specifications shall be carried out whenever changes are necessary. 16.14 Pharmacopoeia, reference standards, working standards, references, spectra, other reference materials and technical books, as required, shall be available in the Quality Control Laboratory of the licensee.