February 24, 2018 |
FDAnews Management Report: The Essential Guide to Combination Products cGMPs
November 18, 2013  | 

Because combination products blur the lines among drugs, biologics and devices, the challenge is determining which rules take precedence — drug GMP rules or device QSR rules. These two regulations are similar, but where they differ, you must take extra steps to ensure both rules are complied with. And numerous variables come into play when deciding which rules apply in which circumstances, such as:

  • Drug and device components made at separate facilities 
  • Drug and device components manufactured at one facility 
  • Constituents manufactured at different facilities, drug shipped to device facility, then both drug and device sent to third facility for combining 
  • Convenience kits 
  • Investigational products 
  • Point-of-care products 
  • Biological products and human cell and tissue products

In each case, you must determine how to apply the regulations before, during and after the component drug and device products are brought together in the manufacturing process. The FDA has tried to create a clearer path to compliance via its so-called “streamlined approach” to the GMPs. But significant issues remain.

 Look to The Essential Guide to Combination Products cGMPs to discover:

  •  What the FDA expects of you in terms of compliance 
  •  How to define and treat constituent parts of a given product 
  •  How the new rule will affect cross-labeled combination products, single-entity and co-packaged combination products 
  •  Examples of combination products and common challenges they present 
  •  How the new rule affects convenience kits 
  •  How the new rule applies to investigational products 
  •  Definitions and special considerations for point-of-care products 
  •  When and how to file post-approval change submissions with the FDA 
  •  Answers to frequently asked questions  

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