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Part 11 applies to all electronic records that fall under FDA regulations. If an organization can prove to an auditor that their electronic records/signatures are as trustworthy as paper records/ink signatures, the FDA will accept electronic instead of paper.
Which parts of 21 CFR deal with drugs?
eCFR Content Subchapter AGeneral1 99 Subchapter B Food for Human Consumption 100 199 Subchapter C Drugs: General 200 299 Subchapter D Drugs for Human Use 300 499 Subchapter E Animal Drugs, Feeds, and Related Products 500 5997 more rows
What are 21 CFR Part 210 and 211?
21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. 21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.
What does 21 CFR Part 211 deal with?
The general provision section defines the scope of 21 CFR Part 211, stating that it applies to manufacturing, processing, packing, and holding drug products intended for human use. In addition, it clarifies that these regulations apply to prescription and over-the-counter drugs, ensuring that all pharmaceutical
What is 21 CFR Part 4?
This subpart clarifies the application of current good manufacturing practice regulations to combination products, and provides a regulatory framework for designing and implementing the current good manufacturing practice operating system at facilities that manufacture co-packaged or single-entity combination products.
The Code of Federal Regulations, Title 21 (21 CFR), contains the U.S. federal regulations for every product regulated by the Food and Drug Administration and Drug Enforcement Administration, including pharmaceuticals, veterinary products, medical devices, cosmetics, and foods.
What are the 21 CFR Part 11 guidelines for pharmaceuticals?
21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.
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