Danish Medicines Agency develops guideline for API audits

Muenster (DE), Copenhagen (DK), 19. Juli 2010.  The Danish Medicines Agency DMA intends to develop an own guideline for API audit reports, which shall provide guidance to finished medicinal product manufacturers for the documentation of the GMP compliance of their active pharmaceutical ingredient (API) suppliers. This is the result of a survey conducted by the DMW last year concerning the GMP surveillance of pharmaceutical companies . "Overall the pharmaceutical manufacturers comply with the relevant GMP obligations concerning the quality of APIs but there seems to be also an obvious lack of minimum standards", comments Dr. Stefan Kettelhoit, of the blue inspection body GmbH (www.blue-inspection.com) the result of the survey. "However, the decision of the Danish Agency to develop a national audit-guideline is not very helpful", according to Kettelhoit.

Dr Kerstin Tabatt joins the team of blue inspection body GmbH as GMP auditor

Münster (Germany), 20 April 2010.  Dr Kerstin Tabatt extends the current team of ten GMP auditors at blue inspection body GmbH (www.blue-inspection.com) effective 1 May 2010. Dr Tabatt has a professional background as a pharmacist and holds a doctorate in pharmaceutical technology. Prior, she worked as a Qualified Person at PenCef Pharma GmbH in Berlin, where supplier audits were part of her responsibilities. Blue inspection body GmbH globally examines the Good Manufacturing Practice (GMP) compliant manufacturing of APIs and medicinal products on behalf of pharmaceutical companies. It is the first accredited Type-A inspection body for this purpose in the European Union.

blue inspection body celebrates 50 GMP audits

Münster (Germany), 20 November 2009.  Two years after founding the company and just 18 months after gaining the accreditation blue inspection body GmbH announced today the successful execution of its 50th GMP audit. Further audit trips to China, India, Israel and various European countries have been scheduled already, meaning that in the first quarter 2010 the 75th audit is targeted to be completed. Blue, as a privately organised inspection body, has thereby set a new benchmark concerning quality and amount of GMP audits for active pharmaceutical ingredients (APIs) in no time at all. The European Directorate for the Quality of Medicines & HealthCare (EDQM) for example, conducted just 28 inspections during 2008.

Wörwag treads unconventional paths in quality assurance

Böblingen, Münster (Germany), 30 April 2009.  Wörwag R&D, specialised in the development of medicinal products, has for the first time sought certification of good manufacturing practices (GMP) for two new generics by an external accredited auditor. The blue inspection body GmbH (www.blue-inspection.com) served as an independent third-party auditor for the GMP compliant manufacturing of Clopidogrel and Losartan. The company is the first accredited, commercially organized inspection body for active pharmaceutical ingredients (APIs) in Europe. "With the external quality assessment of blue inspection body we obtain an additional competitive advantage for our new medicinal products for prophylaxis of thrombosis and the treatment of hypertension”, Dr. Alexander Bachmann, Managing Director of Wörwag R&D GmbH (www.woerwagpharma.de) explains: "These accredited API audits underline our pioneering role in quality assurance.”

EDQM suspends Certificates of Suitability for Chinese APIs

Muenster (Germany), 22. April 2009.  On April 14th, 2009 the European Directorate for the Quality of Medicines & HealthCare (EDQM) has suspended the Certificates of Suitability of four active pharmaceutical ingredients (APIs) manufactured in China. Two Benzylpenicillin products (R0-CEP 2004-001-Rev 00, R0-CEP 2004-017-Rev 00) of the company Hebei Huari Pharmaceuticals Ltd. as well as Dihydrostreptomycin sulphate (R1-CEP 2000-069-Rev 00) and Neomycin sulphate (R0-CEP 2001-317-Rev 02) of Sichuan Long March Pharmaceutical Co. Ltd are affected. "The EDQM auditors have obviously detected that these APIs are not manufactured according to the submitted documentation or in line with the requirements of ICH Q7", explained Dr. Wolfgang Heisig from the blue inspection body GmbH (www.blue-inspection.com) the proceedings of the EDQM. "Since the associated risk has changed, European pharmaceutical manufacturers should now also assess those APIs manufactured in the same premises, which have not been objected".

blue inspection body audits active pharmaceutical ingredient manufacturers in China und India

Muenster (Germany), 13 February 2009.  The audit service provider blue inspection body GmbH (www.blue-inspection.com) will be conducting third-party audits of excipient and active pharmaceutical ingredient (API) manufacturers in Asia at the beginning of March. The company, accredited for this purpose, offers manufacturing authorisation holders in Europe to take part in this audit travel in order to qualify their suppliers from the regions of Hyderabad (India) and Shandong (China).

blue inspection body releases Chinese web site

Muenster (Germany), 21 October 2008.  The German audit service provider blue inspection body GmbH has just released a Chinese version of its new web site www.blue-inspection.com. "Since the majority of our auditees is located in Asia – with most of them in China – the release of our web site in a local language is a matter of course." explains Dr. Stefan Kettelhoit, the managing director. The blue inspection body GmbH is the first accredited audit service provider (type A) for active pharmaceutical ingredients (APIs). The company conducts GMP audits of API suppliers on behalf of pharmaceutical manufacturers and marketing authorisation holders.

API inspection company blue inspection body appoints Prof. Dr. Werner Fresenius to its advisory board

Muenster (Germany), 26 June 2008.  Audit service provider blue inspection body GmbH (www.blue-inspection.com) has appointed Prof. Dr. Werner Fresenius, for many years head of medicinal product surveillance in Rheinland-Pfalz, Germany, as chairman of its advisory board. Other members of the newly constituted board are Dr. Hans-Joachim Janhsen, Managing Director of CardioSec Clinical Research GmbH, and Dr. Eckhard Milsmann, Qualified Person at HAELSA Pharma GmbH. Together they advise the management of blue on all scientific and technical aspects of the worldwide auditing of active pharmaceutical ingredients. Working for the pharmaceutical industry, blue carries out accredited active pharmaceutical ingredient audits worldwide and checks good manufacturing practice (GMP) at supplier companies.

Drug safety: first "type A" accreditation for independent API inspections awarded

Muenster (Germany), 10 June 2008.  The blue inspection body GmbH (www.blue-inspection.com) is the first inspection body for active pharmaceutical ingredients (API) in the European Union to be accredited with the highest level of independence, type A. The audit service provider operates worldwide on behalf of pharmaceutical companies to check whether API suppliers meet the requirements of Good Manufacturing Practice. Audits are considered an important means of improving the safety of medicinal products. Since 2006 they have been required for active pharmaceutical ingredients manufactured in other countries to be allowed to undergo further processing in Europe. It is estimated that almost 80% of all starting materials and excipients for medicinal products in the EU and the USA come from third countries.

Dr. Wolfgang Heisig the new chief GMP auditor for active pharmaceutical ingredients at blue

Muenster (Germany), 11. March 2008.  The audit service provider blue inspection body GmbH (www.blue-inspection.com) in Muenster, Germany, has strengthened its team of pharmaceutical inspectors by recruiting Dr. Wolfgang Heisig. blue, which operates internationally on behalf of the pharmaceutical industry, checks whether active pharmaceutical ingredient manufacturers meet the requirements of Good Manufacturing Practice (GMP). Dr. Wolfgang Heisig is a pharmacist and has been Head of Quality Control and Qualified Person for over 15 years. He joined blue inspection body GmbH from special medicinal products manufacturer medac GmbH in February, taking up the position of chief GMP auditor.