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Is the recent rise in FDA process validation scrutiny making you nervous? After all, that can mean 483s, warning letters … even manufacturing holds and recalls.
But it doesn’t have to with Best Practices in Pharmaceutical Process Validation.
The FDA has taken a tougher stance on drugmakers’ process validation procedures during inspections; this management report will help you establish validation procedures that pass muster.
It takes a fresh look at the 2011 FDA guidance on process validation, clarifying how to integrate process and equipment validation into a seamless lifecycle so you can meet all FDA expectations.
By incorporating recent examples and using actual 483s and warning letters to illustrate, this report explains how the FDA views process validation errors, shares current regulatory hot buttons and highlights topical regulatory issues so you can stay compliant.
It will guide you through the process of developing risk-based master validation plans that incorporate installation, operational and performance qualification.
And by showing you how to use your validation processes to better identify and control variability in your manufacturing processes, you’ll increase homogeneity both within and between drug lots.
Management Report Takeaways:
- How to integrate process and equipment validation in a master validation plan
- Key points in the FDA’s process validation guidance document
- Key process, equipment and software subject to verification and validation activities
- Differences among installation (IQ), operational (OQ) and performance qualifications (PQ) and how to address common problems with each
- How to integrate IQ, OQ and PQ — along with Part 11 and cybersecurity requirements — into process validation
- How to apply a risk-based approach to the process validation plan
- The role of verification activities in process validation
- How to make best use of verification and validation test report formats
The FDA’s hard line on validation compliance doesn’t have to mean 483s, warning letters or worse. Ensure your processes, procedures and documentation are error-free with Best Practices in Pharmaceutical Process Validation.
About the Contributor
John E. Lincoln, principal of J.E. Lincoln and Associates, has more than 40 years of experience in FDA-regulated industries, working with companies from startups to Fortune 100s in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, quality management system problem remediation and FDA responses.
Who Will Benefit
- Regulatory affairs professionals
- Quality assurance/manufacturing professionals
- Product safety/pharmacovigilance personnel
- Risk management professionals
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Contributor:
John E. Lincoln
ISBN-13:
978-1-60430-201-1
Publication date:
October 2022
Page count:
81
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