The Agency has issued a 37-page draft guidance (here), that describes FDA’s current thinking regarding a wide range of issues regarding various container closure systems, packaging components and testing requirements to ensure that the proposed container closure system is appropriate for the proposed drug product. FDA says that when finalized, this draft guidance will “supersede the guidances for industry Container Closure Systems for Packaging Human Drugs and Biologics (May 1999) and Container Closure Systems for Packaging Human Drugs and Biologics — Questions and Answers (May 2002)”.
FDA discusses a risk-based framework and the factors to be considered when selecting and evaluating the fit for purpose of a container closure system for specific drug product categories. The draft also discusses evaluation of device and device constituent parts and functionality of such components in relation to the drug quality impact on the drug product. It also outlines risk considerations for common dosage forms of drug products. The draft guidance discusses typical quality assessments and control strategies for common dosage forms as well as special considerations for particular packaging components including recommendations for bulk containers.
The Agency indicates that the guidance applies not only to prescription drugs and OTC products that are approved through an NDA or ANDA, but also for OTC products that are permitted marketing under the OTC monograph provisions. Thus, it is clear that the FDA’s focus on OTC products in regard to container closures for monograph products anticipates that manufacturers of OTC monograph products should be making the same type of evaluations when selecting container closures or when making a change to an existing marketed container closure. It is therefore assumed that FDA compliance or surveillance inspections of OTC manufacturers should include evaluation of the firm’s documentation of its analysis and data to support the container closure system it has selected for its marketed OTC product. The Agency notes that it “intends to supplement this guidance with additional guidances to provide topic-specific recommendations related to the general information described in this guidance. These topic specific guidances will address methods related to evaluating and characterizing novel CCSs and provide information about specific quality attributes and testing requirements, including considerations for extractables and leachables evaluations and associated toxicological risk assessments”.
The Agency also notes that “[A]lthough the scope of this guidance excludes stand-alone devices, and its focus is on CCSs that package drugs or biological products, some recommendations described in this guidance also may be applicable to stand-alone devices”.
There is also a section on reporting post approval changes to a container closure system or to device constituent parts and indicates that “the type of information that should be submitted depends on the potential for adverse effects on the safety or effectiveness of the drug”. However, the draft guidance refers readers to other FDA guidances to determine the type of submission that may be required based on the proposed change.
This guidance is a valuable resource because it consolidates information from multiple previously issued guidances and incorporates updated information on newer container closure systems and their evaluation.
