This webinar discusses most, if not all of the important issues surrounding “Auditing of API Facilities”. When and how to perform and audit any API Facilities, how to prepare for an audit, performing an audit and what to examine during the audit. Discussed are the suggested process to follow from initially scheduling the audit, obtaining information before starting an audit, meeting with site personnel and establishing scheduled follow up on findings.
Auditing API Facilities is an important part of assuring API GMP Compliance. Knowing what to ask, look at, question, observe and document all form an important part of API GMP Auditing. Any auditor selected to perform an API GMP Review should have the knowledge and background in ICH.
This session focuses on how to prepare, what to examine, how to organize and identify what are the important issues that should be examined by the auditor. What are critical to the success of an API firm? The topic reviews what are “critical” to an audit’s success and how a firm has a legal and moral obligation to perform audits in a correct manner and follow-up. Q7 GMP was carefully written and negotiated for application both in the USA and internationally. Don’t misinterpret what it expects.