Learn how to figure out the cGMP requirements for a combination products.
Combination products are made up of constitute parts that originate in the pharmaceutical, biopharmaceutical, biotechnology, or medical device sectors. Thus they draw on different conventions and face complex regulatory processes. No single cGMP regulatory framework has
prevailed for these products and obtaining timely regulatory approval has proven challenging.
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Here is a link to the FDA's Guidance for Industry and FDA Staff for cGMP Requirements for Combination Products.
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💉 Here is a link to the Medical Device FDA GMP Regulations:
21 CFR 820: [ Ссылка ]
💊 Here is a link to the Pharma FDA cGMP Regulations:
21 CFR 210: [ Ссылка ]
21 CFR 211: [ Ссылка ]
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💻 If you want to learn more about combination product regulations, consider taking one of our on-demand elearning courses:
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If you need to organise annual combination product cGMP training, we have that covered!
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