"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)
"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)
"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)
"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)
"Many thanks for your conscientiousness, professionalism and hard work showed in the mock audit at our company. Through the effective communications and open discussions, we have learnt about the essential elements of GMP compliance which are very useful to us in upgrading our GMP level."
Xinjiang Nuziline Bio-Pharmaceutical Co. Ltd. (China)
"We, Sunlight Pharm, are glad to have accepted a blue GMP audit. With the expertise, professional quality and careful working attitude, the blue auditors have revealed on the site audit. We recognize blue inspection body very well."
Changzhou Sunlight 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)
"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)
"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)
"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)
"As a global immunosuppressant APIs manufacturer, our production facilities have been approved by CFDA (China) and USFDA. We are pleased to have been audited by blue inspection body as a third-party inspection again, and the professionalism and dedication has impressed us deeply."
Fujian Kerui Pharmaceutical Co., Ltd. (China)
"As a leading manufacturer of high potency APIs, Umicore commits to highest quality and regulatory standards. The successful third party audit conducted by Blue Inspection Body provided another independent confirmation of our cGMP status. Many thanks to the blue inspection team for their professional services."
Umicore Argentina S.A.
"As one of the biggest Carbamazepine (API) manufacturers for the global market, Zhejiang Jiuzhou Pharmaceutical Co., Ltd. has been audited by blue inspection body GmbH. The auditors from blue inspection are very experienced and very open for knowledge sharing. We appreciate their professionalism and hard work."
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China)

Willkommen bei den GxP / GMP-Audit-Experten

Die blue inspection body GmbH ist Europas führender Dienstleister für akkreditierte GMP-Audits von Ausgangsstoff-Herstellern (Excipient Audit) und Wirkstoff-Herstellern (API Audit). Und auch für Fertigarzneimittel prüfen blue-Auditoren weltweit, ob die Zulieferer unserer Kunden nach den Regeln der Guten Herstellungspraxis (Good Manufacturing Practice, GMP) arbeiten.

Akkreditierung

Third-Party-Audits der blue werden von Behörden weltweit anerkannt. Die Unabhängigkeit, Vertraulichkeit und Unparteilichkeit unserer Third-Party-Audits wird von der Deutschen Akkreditierungsstelle DAkkS überwacht. Die Akkreditierung gilt für den in der Urkunde D-IS-18678-01-00 aufgeführten Akkreditierungsumfang. 


blue ist eine EXCiPACT registered certification body. EXCiPACT ist eine Initiative von Industrievereinigungen aus Hilfsstofflieferanten und pharmazeutischer Industrie, die sich zum Ziel gesetzt hat, die Überwachung der Good Manufacturing Practice (GMP) und Good Distribution Practice (GDP) für Hilfsstoffe zu professionalisieren. Die unabhängigen Third-Party-Audits der blue, die Unternehmen nach den festgelegten Standards auditieren, sind dazu speziell durch EXCiPACT zusätzlich qualifiziert.


Hochwertige Audits

Ausgehend von unserer Akkreditierung bieten wir maßgeschneiderte Third-Party-Audits für alle Bereiche der pharmazeutischen Industrie.

Unter anderem sind wir zugelassener Auditor für das internationale Supply-Chain-Konsortium Rx-360.


Unsere Dienstleistungen umfassen produktspezifische Compliance-Audits ebenso wie die Überprüfung der Systemkonformität und individuelle Begutachtungen, zum Beispiel:

Weltweit tätig

Die blue inspection body führt weltweit unter anderem GCP, GLP, GDP, GACP, GEP, GSP, GAMP und GMP-Audits durch. Überzeugen Sie sich von der Vielfalt unserer Dienstleistungen, unseren exzellenten Qualitätsstandards und individuellem Service.

Qualitätsmanagement

Pharmazeutische Unternehmer sind mit sich stetig ändernden Marktgegebenheiten und gesetzlichen Richtlinien konfrontiert. Sie müssen ein immer konsequenteres Risikomanagement und lückenlose GMP-Compliance nachweisen. Wir unterstützen Sie beim pharmazeutischen Qualitätsmanagement.

 

 

blue auditiert unter anderem bei/für:

Lomapharm - Rudolf Lohmann GmbH KG Rx-360 Consortium Diapharm EXCiPACT CCCMHPIE China Chamber of Commerce for Import and Export of Medicines and Health Products Evonik Industries AG Fujian Kerui Pharmaceutical Co., Ltd. Hennig Arzneimittel GmbH & Co. KG Heraeus Precious Metals GmbH & Co. KG - Chemicals Division - Business Unit Pharmaceutical Ingredients Hubei Haosun Pharmaceutical Co. Ltd. (China) 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. Xinjiang Nuziline Bio-Pharmaceutical Co. Ltd. Changzhou Sunlight Pharmaceutical Co., Ltd. (China) Wirtschaftsgenossenschaft deutscher Tierärzte eG Umicore Argentina S.A. Alkaloids Corporation Bloomage Freda Biopharm Co., Ltd. BrightGene Bio-Medical Technology Co., Ltd. CP Pharma