Audits, Inspections, and CDMOs

Preparing CDMOs and Sponsors for Regulatory Inspections

For contract development and manufacturing organizations (CDMOs), navigating regulatory inspections can become complex when multiple clients have different specifications, requirements, and expectations. While sponsors remain responsible for ensuring their contract organizations comply with applicable GMP requirements, effective inspection readiness requires close collaboration between both parties.

In this Ask the Expert discussion, Susan J. Schniepp and Anita Michael of Regulatory Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt of Parexel discuss how CDMOs and their clients can prepare for inspections and respond to regulatory actions.

The experts emphasize that inspection readiness should extend beyond preparing for an individual client inspection. CDMOs should maintain a robust quality system, supported by effective CAPA and investigation processes, deviation management, KPIs, and holistic tracking and trending. Facilities should also be prepared to demonstrate compliance across the six quality systems during GMP inspections, while understanding the specific expectations associated with pre-approval inspections.

By establishing strong quality systems and clearly defining responsibilities between CDMOs and sponsors, organizations can be better prepared to address regulatory inspections and respond effectively when issues arise.

Read the full article and watch the Ask the Expert discussion:

Audits, Inspections, and CDMOs

Link to the Video and Article on Pharmaceutical Technology

Strengthen your inspection readiness with a partner who understands the full regulatory landscape.

RCA supports pharmaceutical and medical device organizations with comprehensive audit preparation, supplier oversight, CDMO qualification, remediation planning, and ongoing quality system optimization. Whether you’re scaling operations or navigating complex regulatory expectations, our experts help you reduce risk and ensure confidence in every inspection.

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Explore our full range of services here: Compliance Assurance Services or connect with our team to discuss your tailored compliance strategy today.