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Jan
06

FDA Warning Letters on Data Integrity Issues

Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry article, we’ll explore 2021 and 2022 FDA Warning Letters on data integrity issues in the pharmaceutical manufacturing sector. We’ll also discuss: Why data integrity controls become more critical during a pandemic. Why data governance measures are essential […]

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Dec
20

FDA Warning Letters – CAPA

FDA Warning Letters for cGMP compliance issues relating to CAPAs If you’re a Pharmaceutical business owner or Quality Manager, you know this all too well — that your deviation management records & CAPA system will be scrutinised during your next GMP compliance audit. Auditors and FDA Inspectors are all but guaranteed to delve deeply into […]

By Connie May | Uncategorized
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Nov
30

GMP Education Topics: Induction Bundles

Did you know you can mix and match GMP education topics when ordering online GMP training courses? You can purchase courses individually or in bulk, depending on your needs. Options for bundles include a discounted pack of any 4 standard courses, a 6-bundle package, an 8-bundle package, a 20 bundle package, and more! The benefit […]

By Connie May | Uncategorized
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Sep
06

What is a GMP Inspection?

GMP inspection (Definition) A GMP inspection (‘GMP compliance audit’) will generally involve an onsite visit by a specially-trained Inspector/Auditor; who examines various components of the manufacturer’s Pharmaceutical Quality System (PQS). The GMP inspection generally includes, but is not limited to, reviews of manufacturing procedures (SOPs) across the product lifecycle, supplier qualification procedures, facilities and equipment […]

By Connie May | Uncategorized
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