A milestone contribution to ensure consistent quality in GMP audits.

· Blue Inspection Body GmbH participates in establishment of VDI expert recommendation for conducting 3rd-party GMP audits. Until now there has been a lack of… more >>

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… more >>

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… more >>

European regulations – the falsified Medicines Directive

· Some implications of the Falsified Medicines Directive (FMD) for Chinese Manufacturers Exporting Medicinal Products, APIs or Excipients to the European Union Dr… more >>

Achieving More Effective and Efficient GMP Auditing

· Adherence to Good Manufacturing Practices (GMP) in API manufacturing is crucial in determining the safety of drug products. Due to the limitations of quality… more >>

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… more >>

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.… more >>

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… more >>

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

· Active ingredients for the production of medicnal products have to be manufact-ured according to the principles of good manufacturing practice (GMP). The… more >>


Blue Inspection Body GmbH
Am Mittelhafen 56
48155 Muenster, Germany
Phone: +49 251 284 972 93