Derived from the normative standards and based on the corresponding experience with quality management systems (QM systems) in the area of ISO standards 9001, 13485 and 15378, Blue offers pure QM system audits. Mock audits of the QM system can, among other things, help manufacturers to prepare for authority inspections. And successfully so: "The audit service definitely supported successful passing of the EU GMP inspection", reports our client RPG Life Science (India).

You want to substantiate your quality level to outside parties?
You want to continuously improve your processes beyond simple self inspections?
You would like to prepare for regulatory inspections?
You want to convince potential customers and supply proof of your production quality?
You want to exhibit full control of audit results?

We have developed a tailor-made solution for these needs exactly: auditee initiated GMP system audits.

Our GMP system audits focus on the implementation of the company's quality system. Key SOPs and key documents are evaluated and assessed in detail. The picture is then completed with product-based examples of your GMP system. Your benefits are:

• Full control of the audit report (e.g. no further distribution of the report)
• Sharing of audit report will enhance trust and customer relationship
• Standardised, transparent audit procedure
• Full confidentiality and an audit by an independent, professional auditing company
• Experienced, qualified auditors with a correct understanding of globally accepted standards

QM system audit offers the auditee the perfect opportunity to: 

• verify the internal quality level against that of external partners;
• implement continuous improvement measures beyond self-inspections;
• prepare for inspections conducted by the authorities; 
• win clients by independent proofs of quality.

Audits self-initiated by the auditees focus on GMP compliance of the quality management system. After checking the pre-defined GMP system process procedures projected for submission, an on-site audit is performed. This audit verifies the proper implementation of GMP system process procedures by random system-specific and product-specific samples.