Tom Buggy on Europe's audit program
Buggy is international quality manager of DSM Anti-Infectives in The Netherlands and part of the Quality Working Group of
the European Chemical Industry Council's Active Pharmaceutical Ingredients Committee (APIC). He is also a key member of the
APIC Audit Program Task Force.
Tom Buggy, PhD
As the European API manufacturers association, APIC fully understands the risks to patients if non-GMP or counterfeit APIs
are used as starting materials in the manufacture of medicinal products. We recognize the importance of supplier qualification
as an effective quality system to approve new suppliers and to periodically evaluate suppliers and manufacturers for ongoing
manufacture. In fact, APIC is preparing a supplier-qualification guidance that should be published in November 2009.
Figure 1: The APIC compliance triangle. QP is qualifed person. (FIGURE IS COURTESY OF T. BUGGY)
One key element we've been dealing with at APIC in terms of supplier qualifications is the on-site audit. When you look at
the overall audit requirements in the pharmaceutical industry and the international requirements ... the audit burden on the
industry is overpowering. APIC has developed a third-party audit program... that is available for the pharmaceutical industry
to use whenever they see the need for a third-party audit that can be shared with many medicinal-product manufacturers (see
Figure 1). The option of a credible independent third-party audit is acceptable to the European authorities as long as certain
principles are followed. Key elements of the APIC audit program are:
- Coordination of the audits by the API Compliance Institute to avoid any potential conflict of interest with APIC members
- A standardized six-step procedure for performing the third-party audit
- A standard approach for an audit of an API manufacturer, which involves two days with two auditors to make sure there is an
effective assessment of GMP compliance
- Most importantly, only APIC-certified auditors are involved.
With regard to auditors, they must have a good background in terms of qualification in chemistry or a related science and
appropriate experience in the pharmaceutical industry. To become an APIC-certified auditor, the individual must pass a five-day
course covering the GMP requirements for APIs, including a workshop on auditing techniques related to APIs. The API Compliance
Institute ensures that the auditors chosen to perform the audit are independent of the customer and the auditee to avoid potential
conflicts of interest. Auditors must also sign a confidentiality agreement.
Auditors [assess] GMP compliance based on the International Conference on Harmonization Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients guideline. Any findings that come out of the audit are explained in full in the closing meeting with the auditee. The auditors
classify the findings using a similar classification system used by the European member-state inspectors and include detailed
evidence for their findings in the audit reports. At the end of the audit, there will be a clear indication whether the GMP-compliance
level has been assessed as satisfactory by the auditors. The APIC audit report can also be shared with other medicinal-product
The key advantage of the APIC audit program is that it is based on the guidances of the European authorities relating to third-party
audits. We think this audit program can contribute significantly to assessing overall supply-chain security of medicines for
the protection of patients. We also agree that the program provides only one option for effective audits. If the industry
as a whole can work together, we can do more to ensure the safety and integrity of the medicines used worldwide.