Revision of Technical Report 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry Manufacturing and Controls Documentation

TR-38 was published by PDA in 2006. A team is being put together to revise the document to update its content to align with current practices and regulations. “This technical report is based on an original PDA commentary that was submitted on October 2004 to Docket number 03N-0059 as a proposed guidance for post-approval change for the FDA’s future consideration under the Pharmaceutical cGMP’s for the 21st Century: Risk-Based Approach Initiative.”

PDA technical documents rely on the contributions of subject matter experts from the industry. Authors from all levels of experience and geographies are encouraged to participate to ensure the documents are accessible and relevant to a wide audience.

This is a virtual position.

Please note this opportunity is available to members only.

If you are interested in joining this team, please submit your application by completing the survey.