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Preparing for an FDA Audit

Preparing for an Audit

Audits - 24 August 2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit

Some people might consider a Quality audit of their facility as an aggravating ordeal–a time to grit one’s teeth and suffer through endless questioning and review. The best organizations, however, view good audits as an opportunity to both showcase their operations, and to emphasize the importance of compliance to management and staff.

Whether it be an internal corporate audit, customer audit, or a regulatory agency audit, there are many elements common to each audit process. In every case, auditors want to see that the following has been implemented:

a state of control in manufacturing operations

a consistent and thorough system of documenting manufacturing and testing data

well-documented and thorough resolution of any Quality issues or Deviations that may have occurred

Over the past number of years, the method of demonstrating these attributes has evolved from having both a very good system of filing paper and knowledgeable people to retrieve documents, to electronic systems that have a clear structure and logic for completing, archiving and retrieving documents. One thing, however, that the evolution in technology hasn’t changed is the importance of demonstrating a Quality unit’s knowledge and command of the document system, and by extension, manufacturing operations.

"An audit is generally an exercise in building confidence--confidence in the mind of the auditor, that capable and effective quality and manufacturing teams are directing operations."

John Carkner
Sr. Consultant, SOLABS QA & Best Practices Unit

Good Quality systems allow for readily accessible information about Corrective Actions (CAPA), Training, Change Control, Investigations, and other Quality Business Processes. A robust and thorough system for documenting and archiving Quality documentation, such as an Enterprise Quality Management System, can help a Quality unit demonstrate a state of control to auditors.

When Deviations, CAPA and Change Control show prompt and thorough review and resolution, it builds confidence in the mind of the auditor that the organization employs a systematic approach to ensuring the Quality of products is in place. When Training is easy to access and well-documented, auditors are more likely to be assured that training is real and effective, and hasn’t just been done for appearance’s sake.

An audit is generally an exercise in building confidence–confidence in the mind of the auditor, that capable and effective quality and manufacturing teams are directing operations. Confidence is more efficiently earned when the review of operations is clear and straightforward.

About the Author
John Carkner has had a career spanning more than 35 years in the pharmaceutical industry. A microbiologist by training, he began his career in Quality Control with Pfizer Canada. John gradually took on more responsibility, including overall Quality for Pfizer’s Canadian manufacturing operations, eventually became Site Leader of their Arnprior, Ontario manufacturing site. When Pfizer divested the Arnprior site in 2009, John began a new phase of his career leading a contract manufacturing organization. He concluded his career as President and CEO of Pillar5 Pharma Inc., and after five years in contract manufacturing, moved to a less structured role as a consultant to the industry.

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