"We are outstandingly satisfied with the blue audit service: having contracted a multitude of different GMP audits for several product categories, we are glad to witness the constant and high standard with a greatly adopted sense for priorities and product-based risks."
Diapharm GmbH & Co. KG
(Germany)
"For Biotech-derived APIs the quality standards are particularly high, therefore we decided to commission an independent third party, namely blue inspection body GmbH, with auditing the GMP compliance of our manufacturer."
OOO NPF Materia Medica Holding
(Russia)
"All the staff in Haosun thank the blue inspection body GmbH for the patient guidance and attentive inspection during the GMP audits in June 2011 and in April 2013 ... We gained a lot from the audit experts for the excellent professional skills and reasoned logical thinking capacity and clear orderliness during the audits."
Hubei Haosun Pharmaceutical Co. Ltd. (China)
"As a major Indian manufacturer of APIs and finished forms, we have commissioned mock-audits of our facilities to blue inspection. Communication and audit service is outstanding and definitely supported successful passing of the EU GMP inspection."
RPG Life Sciences Ltd. (India)
"We are very pleased to have accepted your GMP auditing with our company this time. For the expertise and professional quality your auditors have revealed on the auditing spot, we recognize them very much."
Ningbo Green Health Pharm., Ltd.
(China)
"As a leading supplier of APIs and performance materials, Evonik Industries AG has been audited at several global sites and on different occasions by blue inspection body GmbH. The detailed audits added value to our company and our Pharma-clients."
Evonik Industries AG (Germany)
"As a global leading manufacturer of Sodium Hyaluronate, our production site has been audited by SFDA (China) and US FDA. We are pleased to have been audited this time by Blue Inspection Body GmbH as a third-party inspection. Hereby we would like to express our sincere appreciation for your professionalism, dedication and hard work!"
Bloomage Freda Biopharm Co., Ltd. (China)
"BrightGene Group represents a fast growing, innovative, fully integrated biopharmaceutical company. Accompanied by our European partner, blue has audited our Suzhou facilities. We are glad to testify the exceptional scientific knowledge and the auditing skills."
BrightGene Bio-Medical Technology Co., Ltd. (China)

Welcome to GxP / GMP audit experts

blue inspection body GmbH is Europe's leading service provider of accredited GMP audits of manufacturers of excipients (excipient audit), active substances (API audit) and finished medicinal products. On behalf of our customers worldwide, blue's auditors verify whether suppliers work in accordance with the principles of Good Manufacturing Practice (GMP). 


Accreditation

Autonomy, confidentiality and impartiality of our third-party audits are monitored by the German Accreditation Body (Deutsche Akkreditierungsstelle, DakkS). As a result, third-party audits provided by blue are recognised by authorities throughout the world.


Located in Stuttgart (Germany), mdc medical device certification GmbH is our co-operation partner in the EXCiPACT certification scheme for pharmaceutical excipients. The EXCiPACT certification scheme is an initiative of industrial associations from excipient and pharma suppliers, aiming for a professional surveillance of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance for Excipients. The independent Third-Party-Audits of mdc and blue, which are conducted according to predefined standards, have therefore been especially qualified in addition by EXCiPACT.

High-quality audits

In line with our accreditation, we offer customized third-party audits for all areas of pharmaceutical industry.

Among others, we are an approved auditing firm for the international supply chain consortium Rx-360.


Our services encompass product-specific compliance audits as well as reviews of system conformity and customised expert opinions, such as:


Operating globally

blue inspection body conducts, inter alia, GCP, GLP, GDP, GACP, GEP, GSP, GAMP and GMP audits worldwide. Check out the great variety of our service offerings, high quality standards and custom-tailored service.

Quality management

Pharmaceutical companies face ever-changing market forces and statutory regulations. Hence, they must demonstrate increasingly systematical risk management and consistent GMP compliance. We offer support and guidance in pharmaceutical quality management.

 

Among others, blue audits at/for:

Diapharm Rx-360 Consortium EXCiPACT Evonik Industries AG Hennig Arzneimittel GmbH & Co. KG Hubei Haosun Pharmaceutical Co. Ltd. (China) Lomapharm - Rudolf Lohmann GmbH KG Nabriva Therapeutics AG OOO NPF Materia Medica Holding MEDICE Arzneimittel Pütter GmbH & Co. KG Ningbo Green Health Pharmacueticals, Ltd. ratiopharm GmbH RPG Life Sciences Ltd. Wirtschaftsgenossenschaft deutscher Tierärzte eG Alkaloids Corporation Bloomage Freda Biopharm Co., Ltd. BrightGene Bio-Medical Technology Co., Ltd. CP Pharma