Steve LoCastro

Director, Regulatory Affairs

April 16, 2014

New FDA Guidance Issued for Annual Reportable Changes

A new regulatory guidance in the US has clarified expectations for pharmaceutical companies wishing to transition from an existing pharmaceutical component wash process to another, such as the Westar® Ready-to-Sterilize (RS) process.

The FDA has recently published the following guidance for post-approval manufacturing changes:

Guidance for Industry: CMC (Chemistry, Manufacturing and Controls) Postapproval Manufacturing Changes To Be Documented in Annual Reports (March 2014)

This supplements existing FDA guidances covering post-approval CMC changes and should be used in conjunction with those guidances when evaluating planned changes to a pharmaceutical manufacturing process.

In line with FDA’s Pharmaceutical Quality Initiative, the Agency has moved toward a risk-based approach for assessing pharmaceutical manufacturing process changes. Evaluation of post-approval CMC submissions has led FDA to identify a number of additional post-approval changes that represent a low risk to drug product quality and safety.

This final guidance outlines examples of changes that the Agency would now consider Annual Reportable. Of particular interest to customers contemplating a move to Westar RS products, the guideline clarified Agency thinking on changing contract manufacturing organizations (CMOs) for washing, drying or siliconization processes.

Transferring to a new CMO for washing, drying or siliconization of a primary container closure component is considered to be a minor change under the guidance. The application holder must certify that the CMO’s processes are validated, and that the CMO’s site has been audited and found cGMP compliant (by the application holder or a representative).

Validation of, and quality standards for, the Westar RS wash process are designed to meet regulatory standards. Please contact West’s Technical Customer Support for additional information regarding Westar RS products.