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 […]