Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack)
This book presents Current Good Manufacturing Practice (CGMP) requirements as set forth by the FDA. Supplemented with a handy keyword index, it provides, in a pocket-sized format, the complete and unaltered text of CFR Part 820. The index at the end of the book helps readers find the exact section of the reg they need. The comb binding makes it easy to use and the 3 3/4 inch by 5 1/2 inch size makes it easy to take from the desk top to the shop floor. It is a cost-effective tool for use in documented GMP training programs, for suppliers and vendors who need to be FDA compliant, and technicians who must secure adherence to US FDA regulations.
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acceptance activities accordance adequate adverse effect applicable appropriate approved assurance authority batch calibration changes chapter complaint components conduct conform consultants contain contractors control number corrective and preventive defined Design output deterioration determine device history record device master record distribution documented environmental equipment establish and maintain evaluation executive responsibility finished device functions handling identified implementation in-process individual(s initial inspection installation instructions intended Interpharm/CRC Press LLC labeling limits maintain procedures maintenance Management with executive manufacturer shall ensure manufacturer shall establish manufacturer shall maintain manufacturer's means meet methods necessary needs nonconforming product operations otherwise packaging performed personnel planning preventive action procedures to ensure provisions Purchasing quality audits quality system reasonably received reference regulation release reports representative responsibility sampling signature specifications specified requirements standard statistical storage Subpart suppliers trained unit validation variance verification