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The procedure for managing high quality ought to encompass the organizational structure, treatments, procedures and means, as well as actions to ensure self-confidence which the API will meet its supposed specs for high-quality and purity. All high quality-linked activities ought to be outlined and documented.• SOPs: It's really a penned,
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These templates are managed in an analogous way as supply code. By storing them in the supply code repository it allows us to version the template and hold an entire record of its evolution over time.These user prerequisites should involve the normal functioning array expected (as outlined and signed off on by QA and verified during the DQ).The FAT