Frequently Asked Questions
Frequently asked questions concerning an accredited API inspection of blue inspection body GmbH are summarized hereunder:- Does blue perform inspections of manufacturers for critical excipients, too?
- What is the benefit of an accredited inspection report for the audit sponsor?
- What is your understanding of the term "independent"?
- What are typical third party inspection costs?
- What is the regulatory framework for a GMP inspection of blue inspection body?
- What is the educational and professional background of a blue GMP inspector?
Does blue perform inspections of manufacturers for critical excipients, too?
Yes. The blue inspection body GmbH is accredited for „inspections of excipient and active pharmaceutical ingredient manufacturers for pharmaceutical products and determination of the conformance with international GMP rules“. A GMP inspection of manufacturers for critical excipients is performed accordingly.
What is the benefit of an accredited inspection report for the audit sponsor?
The inspection of manufacturers of active pharmaceutical ingredients or excipients may be performed through qualified employees of the marketing authorization holder or alternatively by independent third party inspectors. Before out-contracting to third parties, the qualification, independence and quality of the inspectors has to be evaluated. The quality management system of blue covers these topics explicitly representing part of the assessment of the accreditation body for the approval of an inspection body. Therefore this obligatory evaluation is considerably facilitated for our customers. In addition, the blue procedures are standardised and transparent i.e. the third party inspection process and related procedures are comprehensible and thoroughly documented. The inspection records are archived (respecting utmost confidentiality). The blue processes are being supervised at least annually by the accreditation body. Consequently, the professional preparation and execution of a blue API inspection results in compiling an accredited inspection report based upon high quality standards and the high number of inspections performed.
What is your understanding of the term "independent"?
The blue inspection body is a so called "Type A" inspection body. Thus the highest degree of independence has been awarded. Neither a direct nor indirect commercial relationship between the auditee (API manufacturer) and blue exists. At the same time, an assigned GMP inspector of blue needs to confirm, for every single accredited third party inspection, that no former relationship and no significant (direct or indirect) financial participation exists and that no subsequent employment at the auditee is intended or expected. The blue inspection body does not perform any custom-specific training or consultancy – just public training sessions are hosted from time to time.
What are typical third party inspection costs?
The costs for an accredited GMP inspection are related to the necessary inspection extent and are laid down in our official price list. Typical inspection costs are in the range of 5,000 to 9,000 Euro.
What is the regulatory framework for a GMP inspection of blue inspection body?
The inspections are generally conducted based upon guideline ICH Q7 corresponding to EU GMP guide part II. In addition further applicable laws, regulations, GMP guidelines and standards such as the German AMWHV, EU GMP guide part I and pharmacopoeial monographs (USP, EP etc.) are considered.
What is the educational and professional background of a blue GMP inspector?
The requirements for the qualification of blue auditors and lead-auditors are laid down in the quality management system of blue inspection body according to international standards. Besides a masters degree in natural science (typically as a pharmacist including PhD thesis) blue inspectors exhibit at least 10 years of professional (industrial) experience including further specific training for inspectors and/or appropriate experience for many years which qualifies him to perform a GMP inspection.
