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FDA 483
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21CFR11
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Title 21 / Chapter I / Subchapter A / Part 11
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FDA Guidance
FDA Guidelines
FDA : Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
FDA Guidelines
FDA : Microbiological Quality Considerations in Non-sterile Drug Manufacturing Guidance for Industry (Draft)
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