Ingredient Supplier Audits – Free of Bias?
September 12th, 2013 // 3:27 pm @ jmpickett
If you work for a pharmaceutical firm, let’s say that you are responsible for ensuring that your company’s excipient suppliers have the proper cGMP quality controls in operation. In past years, you might have relied on the responses that suppliers sent to a questionnaire, but FDA is raising the bar and now wants you to do a site audit for all suppliers. What should you do?
Options for Ingredient Supplier Audits
- You or your auditor can audit every site. But there are problems with this. First, it’s very expensive to audit each site, and not all excipient suppliers are going to let you do an audit. This can be because you are not a big enough customer, or you buy via distributor and are not on a customer list.
- You can get involved in a shared audit and purchase an audit report at a lower price point. Issues here is that the audit was not bias free. If the audit was funded by the manufacturer of the excipient, there is a chance that the auditor may not want to report cGMP problems. Also, if the audit was funded by a pharma company, the auditor could also be hesitant to report cGMP issues because this could cause the pharma company to not use the vendor. Also, the auditor may have lacked the time to assess the quality system for the excipient for cGMP compliance.
- You can accept that the excipient supplier was certified for conformance to cGMPs by a reliable 3rd party, if you do buy from that sort of supplier.
One possible solution can be seen through the International Pharmaceutical Excipients Auditing (IPEA) GMP Comformance Certification Program. In that program, the certification cost is taken by the excipient manufacturuer. There is not a cost to the pharma company for a copy of the certificate from IPEA. It is a free download. If the drug company wants to review the basis upon which IPEA gave certification, the report may be purchased for $800.
As the audit was paid for by the manufacturer of the excipient, there could be a concern about bias. IPEA addressed this in these ways:
- Â All auditors have to agree to company with IPEA’s SOP on conflict of interest
- A certification audit has to be done by two auditors
- Audit report has to be reviewed by the CEO of IPEA
- Certification must be granted by a certification board, whose members are very highly thought of in the pharma and excipient business
- Several drug companies compared their audits of a certain excipient supplier with the IPEA report and determined the latter was comparable
- IPEA does an annual audit and sends in a different auditor on a periodic basis
There is a concern that the certification audit is not comprehensive so as to fully assess the site, but this is reduced by IPEA spending about four days on the site, rather than the one day audit by the drug customer.
Also, all IPEA auditors have a high level of experience, as they are either retired from the drug industry and worked in audits of suppliers, or worked with IPEC to develop excipient cGMPs.
Major drug companies seem to be hesitant to accept certification rather than a site audit. Managers say that they are not sure that FDA auditors will accept this reliance on certification as part of supplier qualification.
For more information about qualifying your vendors, please refer to our upcoming webinar – Qualify Your Vendors, Designing and Implementing a cGMP-Compliant Vendor Program.
