FDA finalizes COVID-era guidance on container closure changes

The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors in reporting common changes made to glass vials and stoppers, called container closure systems (CCS), used to hold sterile drug or biological products administered parenterally. The guidance applies to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs).

The guidance was developed by the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER).

The guidance replaces a former version issued during the COVID-19 public health emergency in March 2021 to ensure the uninterrupted supply of glass vials and stoppers used to hold therapeutics in the event that postapproval changes made to these systems could hold up their supply. (RELATED: COVID-19: FDA offers guidance on container closure switches, Regulatory Focus 4 March 2021).

The agency said that “many of the recommendations set forth in the 2021 guidance are applicable outside the context of the section 319 public health emergency.” The guidance revises the former version by removing references to the public health emergency.

The document compiles a listing of various guidances that are available to assist sponsors seeking to change their CCS, discusses the risk-based tools used by FDA to assess these changes, and includes an appendix of tables that list the reporting category of some common changes to CCS systems and the information needed to support changes.

FDA said it takes a risk-based approach to evaluating CCS changes and “the suitability and compatibility of a CCS depends not only on the properties of a container, but also on the properties of other CCS components and their interactions with the drug product formulation over its intended shelf life.”

The agency specifies that applicants must validate the effects of a CCS change prior to distributing their products and conduct additional qualification tests to address product specific risks if necessary.

The tables list the various changes that can be made to a CCS, such as switching from a glass vial to plastic, or going from amber glass to clear glass, or changing the materials in the stopper.

Other changes include switching the source of site of manufacturing or changing the manufacturing or processing of glass vials and stoppers.

Applicants can contact FDA if they do not see the specific information regarding their CCS change listed in the guidance if interested in obtaining feedback.

FDA said that tables “provide baseline recommendations” but “do not consider the cumulative effect of concurrent changes.”

Comments on this guidance may be submitted at any time. Submit comments to Docket No. FDA-2017-D-6821.

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FDA finalizes COVID-era guidance on container closure changes

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