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 structure, the entire and unaltered textual content of CFR half 820. The index on the finish of the ebook is helping readers locate the precise component to the reg they wish. the brush binding makes it effortless to take advantage of and the three 3/4 inch by way of five half inch measurement makes it effortless to take from the table most sensible to the store flooring. it's a low-cost instrument 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 Online or Download Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack) PDF
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Additional info for Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack)
Such procedures shall ensure that: (1) All complaints are processed in a uniform and timely manner; (2) Oral complaints are documented upon receipt; and (3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of this chapter, Medical Device Reporting. (b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.
Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mixups. (d) Labeling operations. Each manufacturer shall control labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unit, lot, or batch shall be documented in the DHR. (e) Control number. 65, that control number shall be on or shall accompany the device through distribution. 130 Device packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.
B) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate. 42 PH2208_Pages 10/8/03 9:31 AM Page 43 (c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.