This booklet provides present sturdy production perform (CGMP) specifications as set forth through the FDA. Supplemented with a convenient key-phrase index, it offers, in a pocket-sized layout, the entire and unaltered textual content of CFR half 820. The index on the finish of the publication is helping readers locate the precise portion of the reg they wish. the brush binding makes it effortless to exploit and the three 3/4 inch through five 0.5 inch dimension makes it effortless to take from the table best to the store flooring. it's a most economical device to be used in documented GMP education courses, for providers and owners who have to 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 resources for Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack)
B) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met. (1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s). (2) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.
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. (b) Each manufacturer shall maintain distribution records which include or refer to the location of: (1) The name and address of the initial consignee; (2) The identification and quantity of devices shipped; (3) The date shipped; and (4) Any control number(s) used.
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. (g) If a manufacturer’s formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either: (1) A location in the United States where the manufacturer’s records are regularly kept; or (2) The location of the initial distributor.
Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack) by Interpharm