What does schedule M2 deal with?

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Shikha Chauhan's picture

In India, Schedule M 2 of the Drugs and Cosmetics Act covers aspects of manufacturing of pharmaceutical products. These include: General requirements: Location of the premises, surrounding areas, water system, waste disposal Warehousing area Production areas Ancillary areas Quality control area Health, clothing and sanitation of Workers Personnel Manufacturing, operations and controls: Precautions against mix-up and cross-contamination Sanitation in the manufacturing premises Raw materials Equipment Documentation and records Labels and other printed material Quality assurance Self inspection and quality audit Quality control system Specifications: For raw materials, product containers and closures, in- process and bulk products, finished products, preparation of containers and closures Master formula records Packaging records Batch packaging records Batch processing records Standard operating procedures and records: Sampling, batch numbering, testing, records of analysis Reference samples Reprocessing and recoveries Distribution records Validation and process validation Product recalls Complaints and adverse reactions Site master file: General information, personnel, premises, equipment, sanitation, production, quality control, loan license manufacture and licensee, distribution, complaints and products recall, self inspection, export of drugs Reference: http://globalsourcingsa.com/pharma-manufacturing.html

Thanks and Regards, Shikha Chauhan http://www.pharmainfo.net/shikhachauhan/biography Lecturer (Pharmaceutics) Amity Institute of Pharmacy Amity University Noida Email: schauhan@amity.edu

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