An Explanation Of IPEC Guidelines

By Patty Benson, Director of Quality Assurance, SAFC

The required standards for manufacturing active pharmaceutical ingredients (APIs) are laid out in GMP (good manufacturing practice) requirements. All competent API manufacturers are well aware of these guidelines and must adhere to them, but they only apply to the API and not the excipient. These non-active ingredients (excipients) are also critical to drug product manufacture and thus must be controlled. Unlike API's, there is no formal regulation for excipient manufacture, however, the International Pharmaceutical Excipients Council (IPEC) has developed a comprehensive guideline to assist Manufacturers in controlling excipients. These guidelines, along with regulations such as 21CFR 820 can be used as the basis for a supplier's overall approach for providing high quality, well documented critical raw materials for the pharmaceutical and biopharmaceutical industry.

It is to be noted that these are not a formal set of standards to which companies must adhere. Instead, the IPEC guidelines work as a proxy, and drug product manufacturers expect excipient suppliers to meet the general controls. This is an important distinction: many of the companies who make excipients are not dedicated pharmaceutical ingredient manufacturers. Rather, the vast majority of their production is destined for the food industry or general chemical use, and if the formal requirements become too onerous, they will be tempted to walk away from the business. The cost of formal compliance would simply not be worth their while for the small proportion of the business pharma represents.

While there are no formal regulations, there is an industry expectation that excipients should be manufactured under GMP conditions. However, unlike APIs where the GMP is legally enforced by the regulators, here the enforcement is generally being done by the drug product manufacturers themselves. The IPEC guidelines provide a baseline to operate from and are essentially a combination of the relevant parts of ISO 9001 and ICH Q7 guidance for API manufacture.