Audits
GMP audit programme
The goal of the GMP audit programme is to help European pharmaceutical companies share the cost of audits of manufacturers in Asia.
The audits are carried out by an independent team based in Hangzhou, China, headed by Philippe Andre, pharmacist and APIC-certified auditor. Philippe Andre has been auditing pharmaceutical factories in China and other Asian countries since 2009. We are qualified to audit active pharmaceutical substances, excipients, medicines and medical devices.
AUDITS IMPROVE THE QUALITY AND COMPLIANCE OF PRODUCTS
Our working method
We start each audit project based on customer requests and then present the audit results to potentially interested companies. The price is determined based on the number of interested customers, who can then confirm their order if they agree on the price. To protect the commercial information of our customers, no participant will be informed about the identity of any other participants.
After the report is issued, we request a corrective action plan from the company that was audited, which is followed up by Laboratory Ofichem. Customers receive updates as we receive them from the audited company.
Each audit report includes an executive summary, recommendation, a list of non-compliance issues, as well as detailed comments on quality management, staff training, facilities, equipment, material management, production management, packaging and laboratory checks. For each subsection, a list of areas that were visited and revised documents are also provided.
The focus of each audit depends on the circumstances. In the case of multi-product equipment, for example, cross-contamination control and cleaning validation will be carefully assessed. For fermentation products, the microbiological purity of the broth would be an area of concern. In all cases, the protection of the integrity of analytical data is reviewed.
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