api-compliance.org

API Compliance Institute

Independent GMP Compliance Audits of API Manufacturers -. Third Party Audit performed at Excella in Germany. Re-Audit at Pfizer Global Manufacturing in Kalamazoo. Boehringer Ingelheim participated in the APIC Audit Programme. A Third Party GMP Audit performed in Belgium. Questions and Answer Document on GMP Third Party Audits at API manufacturers. APIC Revised Third-Party Auditing Programme for APIs. Dr Tom Buggy explains the APIC Audit Programm in this free webcast. ICH Q7 Compliance Week.

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Independent GMP Compliance Audits of API Manufacturers -. Third Party Audit performed at Excella in Germany. Re-Audit at Pfizer Global Manufacturing in Kalamazoo. Boehringer Ingelheim participated in the APIC Audit Programme. A Third Party GMP Audit performed in Belgium. Questions and Answer Document on GMP Third Party Audits at API manufacturers. APIC Revised Third-Party Auditing Programme for APIs. Dr Tom Buggy explains the APIC Audit Programm in this free webcast. ICH Q7 Compliance Week.

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1 about us

2 apic audit programme

3 auditors

4 apic publications

5 qualification courses

6 login download area

7 username

8 case studies

9 regulatory information

10 the apic scheme

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API Compliance Institute | api-compliance.org Reviews

https://api-compliance.org

Independent GMP Compliance Audits of API Manufacturers -. Third Party Audit performed at Excella in Germany. Re-Audit at Pfizer Global Manufacturing in Kalamazoo. Boehringer Ingelheim participated in the APIC Audit Programme. A Third Party GMP Audit performed in Belgium. Questions and Answer Document on GMP Third Party Audits at API manufacturers. APIC Revised Third-Party Auditing Programme for APIs. Dr Tom Buggy explains the APIC Audit Programm in this free webcast. ICH Q7 Compliance Week.

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api-compliance.org

1

Contact - API Compliance Institute

http://www.api-compliance.org/mse_APICOMPLIANCE_Additional3.html

If you are interested in joining The APIC Audit Programme, please contact us for further information:. PO Box 10 17 64. 69007 Heidelberg, Germany. Phone 49-(0) 6221 - 84 44 0. Fax 49-(0) 6221 - 84 44 34. Mr Pieter van der Hoeven. CEFIC Active Pharmaceutical Ingredients Committee (APIC). Av E Van Nieuwenhuyse 4 / box 2. 1160 Brussels, Belgium. Phone 32 2 676 72 02. Fax 32 2 676 73 01. For questions or comments you could send a message to CONCEPT HEIDELBERG at info(at)concept-heidelberg(dot)de.

2

Qualification Courses - API Compliance Institute

http://www.api-compliance.org/mse_APICOMPLIANCE_Venue.html

APIC has developed qualification courses to provide an excellent knowledge of the requirements laid down in ICH Q7. To read more about the current programme at: www.ichq7a-week.org. Choose between two 3-day GMP education courses according to your field of interest: ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis or ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation. At which stage of production will GMP compliance be necessary and how can it be verified? The "ICH Q7 Audito...

3

The Auditors - API Compliance Institute

http://www.api-compliance.org/mse_APICOMPLIANCE_Speakers.html

In general, the audits will be conducted by two auditors who are registered as APIC certified auditors. Will undergo extensive training programmes and have to verify their professional experience. APIC will authorise a register of certified auditors who are allowed to conduct the audits within the framework of the "APIC Audit Programme.". In order to qualify as an APIC Certified Auditor, you need to have:. The necessary educational background and communication skills and.

4

About us - API Compliance Institute

http://www.api-compliance.org/mse_APICOMPLIANCE_About-us.html

The API Compliance Institute. The API Compliance Institute was founded on 19 December 2002. The basis for the activities of the API Compliance Institute is constituted by a contractual agreement between APIC, a sector group of CEFIC, and CONCEPT HEIDELBERG. It is the mission of the API Compliance Institute to standardise GMP audits of API manufacturers and to minimise the costs of compliance audits. To be the recognised voice of this sector with the competent authorities. And http:/ www.cefic.org/. CONCE...

5

APIC Publications - API Compliance Institute

http://www.api-compliance.org/mse_APICOMPLIANCE_Exhibition.html

Revised APIC Auditing Programme. According to the revised EU legislation. The holder of a manufacturing authorization shall at least be obliged to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. You will find the APIC Auditing Programme here.

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concept-heidelberg.de

GMP-Entwicklung - Concept Heidelberg GmbH

http://www.concept-heidelberg.de/unternehmen/gmp-entwicklung.html

Definitionen zu GMP und GDP. GMP und GDP E-Learning. Definitionen zu GMP und GDP. Die folgende Darstellung zeigt Ihnen wichtige Meilensteine bei der Etablierung der GMP-Anforderungen weltweit. Food and Cosmetic Act (FD&C Act). Aufgrund von 107 Todesfällen in den USA wird eine Gesetzgebung angestoßen, die auch den Herstellungsprozess regelt. Kefauver-Harris Drug Amendments, die rechtliche Grundlage für die weltweit ersten gesetzlich geforderten GMP-Regeln (USA). Gründung der CONCEPT HEIDELBERG GMBH. Die F...

concept-heidelberg.com

Websites - Concept Heidelberg GmbH

http://www.concept-heidelberg.com/company/websites.html

GMP and GDP Certification. GMP and GDP eLearning. Concept Heidelberg owns more than 30 websites dedicated to larger Conferences and Congresses but also for diverse GMP/GDP services. Moreover, we also collaborate with associations and manage many members portals. ICH Q7 Compliance Week. GMPs for Pharmaceutical Excipients. Pharmaceutical Microbiology Working Group. Good Distribution Practice Group (GDP). Company brochure (417.5 KiB). We are there for you! 49 6221 84 44 0. GMP and GDP Certification.

concept-heidelberg.de

GMP-Compliance Audits - Concept Heidelberg GmbH

http://www.concept-heidelberg.de/services/apic-audit.html

Definitionen zu GMP und GDP. GMP und GDP E-Learning. GMP-Compliance Audits für API-Hersteller. Das APIC Audit Programme ist ein "Third Party Audit Programme", um Hersteller von Active Pharmaceutical Ingredients (APIs Wirkstoffe) zu auditieren. Zur Umsetzung des Programms haben die APIC in Brüssel und Concept Heidelberg eine vertragliche Vereinbarung getroffen und im Dezember 2002 das " API Compliance Institute. Hier finden Sie mehr Informationen:. Unternehmensbroschüre (437,1 KiB). Wir sind für Sie da!

concept-heidelberg.de

Websites - Concept Heidelberg GmbH

http://www.concept-heidelberg.de/unternehmen/websites.html

Definitionen zu GMP und GDP. GMP und GDP E-Learning. Definitionen zu GMP und GDP. Concept Heidelberg betreibt über 30 Webseiten. Für große Konferenzen und Kongresse gibt es ebenso Webseiten wie auch zu den diversen GMP/GDP-Services, die wir anbieten. Zudem betreiben wie in Kooperation mit Verbänden und Interessengruppen diverse Mitgliederportale. ICH Q7 Compliance Week. GMPs for Pharmaceutical Excipients. Pharmaceutical Microbiology Working Group. Good Distribution Practice Group (GDP). 49 6221 84 44 0.

concept-heidelberg.com

APIC Audit Programme - Concept Heidelberg GmbH

http://www.concept-heidelberg.com/service/apic-audit-programme.html

GMP and GDP Certification. GMP and GDP eLearning. GMP compliance audits for API manufacturers. The APIC Audit Programme is a third party audit programme to audit manufacturers of Active Pharmaceutical Ingredients (APIs). To implement the programme the APIC and Concept Heidelberg signed an agreement and founded the " API Compliance Institute. To find out more about the APIC Audit Programme please see at. Company brochure (417.5 KiB). We are there for you! 49 6221 84 44 0. GMP and GDP Certification.

auceris.de

Compliance für die Pharma- und Medizintechnikindustrie - auceris.de

https://auceris.de/index.php

80 Schulungen pro Jahr. Wir unterstützen Unternehmen der Pharma- und Medizintechnikindustrie in allen Fragen der Compliance. Die Anforderungen von Behörden sowie die Erwartungshaltung ihrer Kunden stellen eine zunehmende Herausforderung an die Implementierung, Aufrechterhaltung und Weiterentwicklung des QM-Systems in der Pharmazeutischen- und Medizinprodukteindustrie dar. Wir verstehen unter Compliance nicht nur die reine Einhaltung von Gesetzen, Richtlinien und Normen, sondern auch den für die Unter...

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API Compliance Institute

Independent GMP Compliance Audits of API Manufacturers -. Third Party Audit performed at Excella in Germany. Re-Audit at Pfizer Global Manufacturing in Kalamazoo. Boehringer Ingelheim participated in the APIC Audit Programme. A Third Party GMP Audit performed in Belgium. Questions and Answer Document on GMP Third Party Audits at API manufacturers. APIC Revised Third-Party Auditing Programme for APIs. Dr Tom Buggy explains the APIC Audit Programm in this free webcast. ICH Q7 Compliance Week.

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