The U.S. Food and Drug Administration issued the Final rules on the current good manufacturing practice ("cGMP") requirements for combination products in the Federal Register Notice, 78 Fed. Reg. 4307, published Jan. 22, 2013 (the "Notice"). The Notice effectively clarifies which elements from cGMP regulations are necessary to ensure compliance for combination products.
The cGMPs are regulations that the manufacturers of medical products must follow to avoid a charge of product adulteration. Adulteration is essentially a company's failure in manufacturing its products in accordance with cGMP practice, regardless of whether the products are actually deficient in some respect. 21 C.F.R. §§ 210 and 211 describe the cGMP requirements for drugs. The Quality System Requirements for devices are codified in 21 C.F.R. 820. For biologics, the requirements are listed in 21 C.F.R. 600 through 680; and for human cells and tissues, the good tissue practice is articulated in 21 C.F.R. 1271, subpart D.
Combination products are defined in 21 C.F.R. § 3.2(e) as those that comprise two or more FDA regulated components. Manufacturers of such products must satisfy cGMP compliance for all of the components included in the product, whether the product is single entity or a co-packaged combination product. The Notice clarifies the mechanism of compliance with cGMP for combination products. For example, when the first component of a combination product is a drug that complies with its respective cGMP requirements, the Notice provides clarification as to which regulations must further be complied with for the device component of such combination product and vice versa.
Manufactures of combination products should carefully consider the newly finalized 21 C.F.R. 4.4(b)(2) during or before developing their cGMP compliance programs.
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