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21 CFR 4 - cGMP for Combination Products

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978-1-935131-69-4

US FDA Title 21 CFR Part 4 Pocket Guide

  • cGMP for Combination Products

This regulation pertains to products comprised of any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product.

The FDA intended for the rule to help ensure that CGMP requirements that apply to single-entity and co-packaged combination products are clear and consistent, regardless of which Agency component has lead jurisdiction for the combination product, or which type of application is submitted for marketing authorization. The proposed rule was also intended to streamline demonstrating compliance with CGMP requirements for these types of combination products and to help ensure appropriate implementation of these requirements while avoiding unnecessary redundancy in CGMP operating systems for these products.

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Other GMP Products that you may be interested in:

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21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master

  • 21 CFR Part 3 Product Jurisdiction
  • 21 CFR Part 4 cGMP for Combination Products
  • 21 CFR Part 11 - Electronic Records; Electronic Signatures
  • 21 CFR Parts 210/211 - Drug GMPs
  • 21 CFR Part 820 - Quality Systems Regulations
  • ICH Q7A - GMPs for Active Pharmaceutical Ingredients
  • Definition of a Combination Product
  • Frequently Asked Questions (FAQs) for Combination Products
  • Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products

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