GMP Audits

Special Reports
Data integrity continues to be a very hot topic for both regulators and the pharmaceutical industry. With the increased observations about data integrity in laboratories, could it be that analysts have changed how they do science in the laboratory? Are...
Training
Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned...
Training
This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic....
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FDA's Regulatory Procedures Manual Provides information on internal procedures to be used in processing domestic and import regulatory and enforcement activities. While the RPM is intended mainly to provide guidance to...
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Considerations in GMP Auditing Covers some of the basic considerations for GMP auditors to review. Using GMP Checklists In GMP Auditing Discusses the pros and cons of using checklists when conducting GMP audits, and how...
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Expand All Australian Good Manufacturing Practice Guidance Documents Questions & answers on the code of good manufacturing practice for medicinal products (16 September 2010) This document provides guidance on the...
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Disclaimer This GMP audit checklist is intended to aid in the systematic audit of a facility that manufactures drug components or finished products. The adequacy of any procedures is subject to the interpretation of the...
Regulatory
The following is a quick list of things to do as an auditor. Using this list will help you to make sure that you are on track as you plan and conduct GMP audits. Maintain and Use a Written SOP for GMP Auditing...
iSpeak Blog
If an FDA inspector surprises you by asking questions about downstream microbial and endotoxin control, could you convince the inspector that you have adequate control over your downstream process to prevent a contamination? In recent audits, the FDA has...