Compact Regs Parts 820: CFR 21 Part 820 Quality System Regulation (10 Pack)Interpharm CRC Press, 2003. gada 17. nov. - 64 lappuses 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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820 Subpart acceptance activities acceptance status accuracy and precision adverse effect applicable appropriate CGMP changes class I devices components contractors control number corrective and preventive date and signature Design controls Design history file Design output Design validation designated individual(s deterioration device history record device master record device's establish and maintain evaluation executive responsibility finished device acceptance in-process including the date inspection installation instructions and procedures intended Interpharm/CRC Press LLC investigation labeling maintain procedures Management with executive manufacturer shall ensure manufacturer shall establish manufacturer shall maintain manufacturer's manufacturing material manufacturing practice methods nonconforming product Packaging and labeling performed personnel prevent mixups preventive action procedures shall ensure procedures shall include procedures to control procedures to ensure process controls quality audits quality policy quality problems Quality system record quality system requirement radionuclide released for distribution rework specified requirements storage teletherapy test equipment Traceability valid statistical