APIC-CEFIC Audit Programm – Ein Erfahrungsbericht

APIC-CEFIC Audit Programme – An Experience Report by GENZYME Pharmaceuticals, Liestal (Switzerland) GENZYME Pharmaceuticals, Liestal (Switzerland), a branch of the US-American, Boston-based biotechnology company Genzyme, is a manufacturer of pharmaceutical excipients and APIs and a contract manufacturer for the pharmaceutical industry. Notwithstanding the fact that companies in this field are audited regularly by the competent registration authorities (in the case of GENZYME: RHI (Switzerland) and FDA), their customers and partners conduct an increasing number of audits, which causes the audited enterprise a not insignificant amount of additional work. In 2004, GENZYME Pharmaceuticals, a firm with 100 employees, spent 50 days on customer audits. With the aim of counteracting this tendency, APIC-CEFIC initiated an independent Audit Programme in co-operation with CONCEPT HEIDELBERG. By means of having a standardised audit conducted by qualified and certified auditors and giving the customer insight into the audit report, the customer's confidence in the quality assurance system and in the compliance with the ICH Q7A requirements is intended to be reinforced and thus the number of customer audits, minimised. Preparing the Audit After applying for an APIC-CEFIC Audit in March 2003, GENZYME Pharmaceuticals first had to fill in a questionnaire that formed the basis for the selection of the two auditors and at the same time helped the auditors to ...