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SOP is essential document that includes written instructions, it must be followed for the good laboratory management system. It covers all the activities of the laboratory (Safety, Technical, Hygiene, Administration). A well written SOP should be concise, detailed and clear so that it can be read and understood easily. The key elements of a well written SOP are consistency and accuracy, a good SOP provides Total Quality System of the laboratory. Part 211- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart F - Production and Process Controls Sec. 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate orga...
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