Audits & Inspections – Do’s and Don’t’s

What is the meaning of the words Audits and Inspections? Audits as well as Inspections are terms, which are regularly used in the field of Good Manufacturing Practice (GMP). What exactly is the meaning of these terms and what are similarities or differences, respectively?

Good Manufacturing Practice (GMP) – compliance is a must!

Besides regulatory compliance (=compliance with the approved marketing authorisation (MA) to ensure contemporary requirements of safety, quality and efficacy are constantly met), GMP compliance (=compliance with applicable current GMP guidelines to ensure high quality standards concerning manufacture and control are met) is a must for pharmaceutical manufacturers.

European regulations – the falsified Medicines Directive

What was the reason for issuing the FMD? At the beginning of the so called Falsified Medicines Directive (Directive 2011/62/EU) it is stated, that there is an “alarming increase of medicinal products detected in the European Union which are falsified in relation to their identity, history or source. Those products usually contain sub-standard or falsified […]

Typische GMP-Defizite bei Herstellern von chemischen Wirkstoffen

Die Audit-Erfahrung zeigt, dass bestimmte GMP-Defizite häufiger auftreten. In diesem Unterkapitel werden typische GMP-Defizite gemäß der Audit-Erfahrung des Autors vorgestellt. Die nachfolgende Auflistung ist dabei nach den Kapiteln des EU-GMP-Leitfadens Teil II strukturiert (Vorgabetext kursiv) und erhebt weder Anspruch auf Vollständigkeit noch eine Wertung/Klassifizierung der einzelnen Defizite.

Achieving More Effective and Efficient GMP Auditing

Adherence to GMP in API manufacturing is crucial in determining the safety of drug products. Due to the limitations of quality-control testing and repeatedly occurring major API adulterations, the regulations for supplier qualification have been globally tightened. As a consequence, authorities demand more vigilance of the pharmaceutical supply chain. API and other starting material manufacturers […]

Risk-Based Auditing of Active Pharmaceutical Ingredient Manufacturers – Recommendations for Standards and Minimal Requirements

The safety of medicinal products is to a major extent determined by the quality standards adhered to during manufacturing and quality control. Manufacturing Authorisation Holders (MAHs) are therefore obliged to use audits to ensure that all active pharmaceutical ingredients (APIs) used comply with Good Manufacturing Practice (GMP).

GMP for Active Pharmaceutical Ingredients: judging the audit quality from the audit report

Manufacturing authorisation holders (MAHs) are obliged to ensure compliance with the Good Manufacturing Practices (GMP) throughout the complete process chain. Suppliers of active pharmaceutical ingredients (APIs) and other critical raw materials/excipients must be explicitly qualified through on-site audits. The resulting audit report serves as objective evidence for the competent authority that the respective audit obligation […]

API Manufacturing: Complying with International GMP Regulations

Asian Manufacturers of Active Pharmaceutical Ingredients (API) have to adhere to Good Manufacturing Practice (GMP) guidelines in order to penetrate Western markets. The majority of medicinal products manufactured in Europe and the US contain Active Pharmaceutical Ingredients (APIs) and excipients which have been manufactured in Asia. In recent years, these active and inactive pharmaceutical ingredients […]

Auditing / Qualification of Active Pharmaceutical Ingredient Manufacturers by Accredited Inspection Bodies

Active ingredients for the production of medicinal products have to be manufactured according to the principles of good manufacturing practice (GMP). The licence holder has to verify this on site. As only few active ingredients are produced in Europe today, a considerable burden is induced by this obligation for every single enterprise. During the last […]