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and packaging has drawn inspectors’ attention towards the need for identifying and clarifying the critical aspects of this specific stage of inspection, in order to have a uniform interpretation of the provisions...
Under the addressees of warning letters with quotations in the area of quality control - 21 CFR 211.166 "Stability Testing" and 21 CFR 211.160 "General Requirements" - there are also many of the companies...
The 25 SOPs provisions under Part 211 include:第211部分中25个SOP条款包括Section 211.22(d)-Responsibilities and procedures of the quality control unit;第211.22(d)---质量控制部门的职责和程序Section 211.56(b)-Sanitation procedures...
Documentation includes specifications and procedures for materials and methods of production and control. The design and use of documents depend upon the research and development facility....
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