If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. 211.182 Equipment cleaning and use log.Ī written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS The information on this page is current as of Jul 20, 2022.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
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