blue – ISO 17020 (type A) accredited inspection body for API GMP audits

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 >>

Contact

blue inspection body GmbH
Hafenweg 18-20
48155 Muenster, Germany
Phone: +49 251 62562040

contactNOSPAM@blue-inspection.com
chinaNOSPAM@blue-inspection.com
indiaNOSPAM@blue-inspection.com

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