This ebook offers present strong production perform (CGMP) specifications as set forth by way of the FDA. Supplemented with a convenient key-phrase index, it presents, in a pocket-sized layout, the whole and unaltered textual content of CFR half 820. The index on the finish of the e-book is helping readers locate the precise element of the reg they wish. the brush binding makes it effortless to take advantage of and the three 3/4 inch by means of five half inch dimension makes it effortless to take from the table most sensible to the store flooring. it's a within your means device to be used in documented GMP education courses, for providers and owners who must be FDA compliant, and technicians who needs to safe adherence to US FDA laws
Read or Download Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack) PDF
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Extra info for Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack)
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160 Distribution. (a) Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Where a device’s fitness for use or quality deteriorates over time, the procedures shall 37 PH2208_Pages 10/8/03 9:31 AM Page 38 ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed.
181 Device master record. Each manufacturer shall maintain device master records (DMR’s). 40. The DMR for each type of device shall include, or refer to the location of, the following information: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; 40 PH2208_Pages 10/8/03 9:31 AM Page 41 (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods.