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Annex 9 Guidelines on packaging for pharmaceutical products
lines for good manufacturing practices (GMP) (1). The requirements to be met by pharmaceutical packaging and pack-aging materials as described in compendia (pharmacopoeias) and standards (e.g. those of the International Organization for Standard-ization (ISO)) must be considered only as general in character. The
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Medical Devices; Current Good Manufacturing Practice (CGMP ...
The FDA is revising the current good manufacturing practice ... CGMP requirements now cover a full quality system. ... FDA made several suggestions to TC 210 on the drafts of the ISO/CD 13485 ...
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ISO - ISO/TC 122 - Packaging
Standardization in the field of packaging with regard to terminology and definitions,characteristics, performance requirements and tests, and utilization of related technologies on packaging. Excluded : matters falling within the scopes of particular committees (e.g. TC 6, 52 and 104).
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A WHO guide to good manufacturing practice (GMP) requirements
WHO defines Good Manufacturing Practices (GMP) as “that part of quality assur-ance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authori-zation” (ref 27). GMP covers all aspects of the manufacturing process: defined manu-
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