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
Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their...
Training
This online course provides you with the basic competencies required to effectively perform the auditor’s assigned responsibilities by defining audits, explaining why audits are carried out, discussing the types and...
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...