The manufacturer of a pharmaceutical excipient when faced with the possibility of an audit of the production of an excipient might ask why.  While the drug product manufacturer is responsible to the Food and Drug Administration for the quality of a drug product, why should an excipient manufacturer allow third party GMP auditors into a facility?  For the purpose of answering this question, excipient manufacturers are divided into two groups: those that manufacturer almost exclusively for the pharmaceutical industry and those pharmaceutical excipient producers whose major customers are outside the pharmaceutical industry. 

The answer to the question, "why" for the first group is obvious.  If a company wants to service the pharmaceutical industry, meeting the industry's requirements and defining the company's products from the competition is essential.  Price and quality are two major industrial drivers.  Price is not an issue of this presentation, but quality and meeting GMP's are.  This is demonstrated by the fact that the PF 28(5) <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients has been published by the U.S. Pharmacopoeia, with the intention of making the guideline mandatory.  One can either wait until the guidelines may become mandatory or prepare for this change by auditing following these guidelines and making adjustments necessary to meet the requirements of the guidelines.  Waiting to take needed action could cause a company to fall behind its competition and may impact its ability to market U.S.P. excipients.  In addition, organizations new to the pharmaceutical excipients marketplace may find it beneficial to tell customers that while the organization may be new to the pharmaceutical excipient market, they have been audited by an independent auditor and meet the U.S.P. Good Manufacturing Practices for Bulk Pharmaceutical Excipients.  This approach also may be particularly advantageous to off-shore companies wishing to sell their excipients to U.S. companies.

Some of the second group of excipient manufacturers have been, on occasion, reluctant to have auditors review their operations. Often, little of their production is sold to the pharmaceutical industry.  This raises the question of why accept the inconvenience of an audit?  For this group, note should be made that U.S.P. labeled products are also sold to other than pharmaceutical companies.  With the anticipated changes in U.S. Pharmacopoeia GMP requirements, the decision becomes one of either wanting or not wanting to be in the business of supplying U.S.P. excipients.  The reasons given with respect to the first group of pharmaceutical excipient manufacturers also applies to this group, once the GMP requirements become mandatory.  If a company wants to supply the industry, quality requirements will have to be met.  Generally, this means that documentation of conformance to GMP requirements will be necessary.

In addition to the foregoing considerations, one should consider GMP compliance as being the first line of defense in a product security program.  Many excipients used by U.S. pharmaceutical companies are from foreign sources.  Audits of the manufacturing and distribution practices of excipients suppliers have become more significant in light of terrorist's global activities.  Audits of GMP programs will help evaluate the quality of this aspect of a drug product manufacturer's product security program.

The answer to why audit an excipient producer should permit third party auditing is to ensure that GMP requirements are being met, obtain an advantage over competition from other excipients producers, support necessary product security programs and facilitate entry of an excipient into a new marketplace.  One must also take into consideration the fact that the FDA has emphasized a risk based approach to cGMPs for the 21 st Century and will be pursuing a science and risk-based approach to product quality regulation incorporating an integrated quality systems approach.  The FDA has emphasized its current priority of reviewing its approach to ensuring the quality of drug products.

The IPEA Auditing Program provides assurance to the excipient purchaser and manufacturer that the excipient's manufacturing process meets GMP requirements.  Also, with the IPEA program, there is the opportunity for both parties to benefit.  Through the Discount Policy , audit sponsors can take advantage of discounts and credits toward future audits.  Excipient manufacturers may benefit from IPEA's sale of reports to third parties through the Audit Report Program , thereby reducing the number of audits they may experience along with the potential disruption in their production owing to these audits.