The API Compliance Institute recently performed a Third Party GMP Audit at

Janssen Pharmaceutica NV
Janssen Pharmaceuticalaan 3
B-2440 Geel
Belgium

The Audit was initiated by a group of Qualified Persons and QA Managers from different pharmaceutical companies who are using the respective APIs to manufacture their medicinal products. The initiators as well as the Auditee agreed to share the audit reports with other companies.

The GMP Audit was performed by 2 certified APIC Auditors during 2 days at the manufacturing site. It was conducted according to the rules of the APIC Audit Programme. This GMP Audit Scheme is an internationally recognized auditing programme which was established 10 years ago. It is the idea of the programme to share compliance information between companies.

The API Compliance Institute is responsible for the controlled distribution of the audit report which describes the GMP compliance situation at the API manufacturing sites in detail. More information can be found in a Press Release from the API Compliance Institute.

Source: API Compliance Institute Website

Related GMP News
04/04/2013	MHRA implements new Software for risk based Inspection Planning
27/02/2013	Are 300 GMP Inspections necessary by 2 July 2013?
20/02/2013	India opens Drug Inspection Office in China
13/02/2013	Up to $190.389 for FDA's New Inspections Fees
12/12/2012	Swiss GMP standards and inspection equivalent to EU