04/15/2024 · 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 >>

04/01/2014 · 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 >>

11/01/2013 · Besides regulatory compliance (=compliance with the approved marketing authorisation (MA) to ensure contemporary requirements of safety, quality and efficacy… more >>

10/01/2013 · Some implications of the Falsified Medicines Directive (FMD) for Chinese Manufacturers Exporting Medicinal Products, APIs or Excipients to the European Union Dr… more >>

02/01/2013 · 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 >>

06/18/2012 · The safety of medicinal products is to a major extent determined by the quality standards adhered to during manufacturing and quality control. Manufacturing… more >>

02/01/2010 · Manufacturing authorisation holders (MAHs) are obliged to ensure compliance with the Good Manufacturing Practices (GMP) throughout the complete process chain.… more >>

07/18/2009 · Asian Manufacturers of Active Pharmaceutical Ingredients (API) have to adhere to Good Manufacturing Practice (GMP) guidelines in order to penetrate Western… more >>

03/18/2009 · Active ingredients for the production of medicnal products have to be manufact-ured according to the principles of good manufacturing practice (GMP). The… more >>