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FDA issues ‘The Essential Guide to Combination Products cGMPs’

With weeks remaining until the FDA’s new cGMP rules kick in, many drug, biologics, and device manufacturers remain unclear about how to comply.

The U.S. Food and Drug Administration’s rule on current Good Manufacturing Practice Requirements for Combination Products, made final in January, goes into effect July 22.

According to FDA, this ruling will affect every combination product—and not a single one is “grandfathered.” They require you not only to review your manufacturing procedures—particularly when different constituent parts are made at separate facilities—but also to:

• Review and/or modify SOPs

• Review and/or modify QC/QA systems

• Institute new employee training programs and protocols

• Make top-to-bottom reviews of dozens of internal processes

A new report from FDAnews, “The Essential Guide to the Combination Products cGMPs” aims to help companies understand the new rules. A press release announcing the publication explains:

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“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.”

The publication offers a guide into 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.


Available in print or PDF, the publication sells for $397 and can be ordered online, by phone at 888.838.5578 (inside the U.S.) or 703.538.7600 (mention priority code 13610 when ordering by phone), or fax your purchase order to 703.538.7676, or mail your check to: FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431.

Combination products represents a newer subcommittee within the Institute of Packaging Professionals’ Medical Device Packaging Technical Committee and is looking for input on a survey with questions about combination product packaging, specifically from a medical device perspective. Contact this author for more information at



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