Combination Products: FDA Proposes Alternative Mechanisms to Comply with GMP Requirements

Regulatory NewsRegulatory News | 13 June 2018 |  By 

Manufacturers of combination products were offered a list on Tuesday of flexible mechanisms that can be used to comply with the US Food and Drug Administration’s (FDA) requirements for good manufacturing practices (GMP).

The proposal satisfies a mandate from the 21st Century Cures Act of 2016 that called on FDA to periodically issue a list identifying the types of combinations products and manufacturing processes for which “alternative or streamlined mechanisms” can help meet the requirements of a 2013 final rule.

To concurrently comply with the agency’s drug GMP requirements and the device Quality System regulation, manufacturers of single-entity and co-packaged combination product can implement an operating system that blends certain provisions of both regulations under the final rule.

In response to stakeholder requests for “a more ‘unified’ approach” at the time the 2013 rule was finalized, FDA said it found “no reason to develop an entirely new regime for combination products” and that “it is appropriate to utilize the well-established and understood” requirements already in place.

The new list is aimed at providing the additional clarifications on the GMP requirements that apply to combination products, with several references made to a January 2017 final guidance on the matter.

Mechanisms described relate to product sample testing and distribution, stability testing, keeping reserve samples, among other requirements specific to products that are regulated as drugs by FDA.

In developing combination products treated as devices for regulatory purposes, mechanisms for compliance include the use of pharmaceutical practices for design controls and exemptions from provisions of the device quality system regulation. The latter “will most frequently apply to co-packaged combination products,” such as a syringe designed for oral dosing, the agency explained.

Sufficient documentation, appropriate evidence and a rationale explanation in support of the chosen approach to compliance should be accessible during FDA manufacturing site inspections. The process for interacting with agency staff, suggestions for content in submissions to FDA, agency review practices and other considerations on the proposed mechanisms are discussed in the list as well.

FDA said it will continue to “continue to evaluate this list in light of agency experience and stakeholder
input” and encouraged manufactures to propose other risk-based approaches for its consideration.

Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; Proposed List Under the 21st Century Cures Act


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