Compact Regs Parts 820: CFR 21 Part 820 Quality System by Interpharm

By Interpharm

This publication offers present reliable production perform (CGMP) specifications as set forth by way of the FDA. Supplemented with a convenient key-phrase index, it offers, in a pocket-sized layout, the full and unaltered textual content of CFR half 820. The index on the finish of the booklet is helping readers locate the precise portion of the reg they want. the brush binding makes it effortless to exploit and the three 3/4 inch by means of five 0.5 inch dimension makes it effortless to take from the table most sensible to the store flooring. it's a low-cost device to be used in documented GMP education courses, for providers and proprietors who must be FDA compliant, and technicians who needs to safe adherence to US FDA laws

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Additional resources for Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack)

Sample text

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.

The record of investigation shall include: (1) The name of the device; (2) The date the complaint was received; (3) Any device identification(s) and control number(s) used; 43 PH2208_Pages 10/8/03 9:31 AM Page 44 (4) The name, address, and phone number of the complainant; (5) The nature and details of the complaint; (6) The dates and results of the investigation; (7) Any corrective action taken; and (8) Any reply to the complainant. (f) When the manufacturer’s formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.

B) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer. (c) Exceptions. 50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.

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