In the Pockets of Millions of Industry Professionals - Your Company can be too! Find out more -

GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 4 - cGMP for Combination Products


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.

Quantity   1 - 24     25 - 49     50 - 99     100 - 249     250 - 499     500 - 999     1000+  
Price $5.95 $5.75 $5.40 $4.95 $4.25 $3.90 $2.95


example: 211, ISBN, Drug, GMP, Etc. - Press Enter
Mix and Match End of Year Special Featured Publication GCP Device GMP GCP-DRUG Featured Publication
  • Guaranteed Lowest Price
  • Quantity Discounts Available
  • Always Current, Up-To-Date
  • Company Logos Available
  • Special Customizations
  • Pocket-sized 3.75" x 6.25"
  • Prep for FDA & Client Audits
  • Employee Training & Reference
  • Promotional "giveaways"
  • Tradeshows and meetings

Our Valued Clients

Return to the GMP Publications home page View your shopping cart-->