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Tablets & Capsules October 2018 43 eye on Jim Morris NSF International excipients This edition of Eye on Excipients dis- cusses how pharmaceutical companies can use good manufacturing practice (GMP) standards and certification programs to ensure that their excipient suppliers meet and maintain established excipient quality standards. Historically, in order to meet pharmaceutical GMP expectations, excipient manufacturers have relied on the International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group's (PQG's) Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients [1]. The two organizations issued this guid- ance in 2006, and it was the product of a significant amount of work by IPEC's members. While the guide provides a great baseline, in the 12 years since its release, the industry has moved on. Excipient manufacturers should now reference either ExciPact's C e r t i f i c a t i o n S t a n d a r d s f o r Pharmaceutical Excipient Suppliers 2017 [2] or NSF International (NSF), I P E C , a n d A m e r i c a n N a t i o n a l Standards Institute's (ANSI's) NSF/ I P E C / A N S I - 3 6 3 - 2 0 1 6 G o o d Manufacturing Practices (GMP) for Pharmaceutical Excipients [3]. Both are contemporary standards and are closely aligned because the organiza- tions based them on the IPEC-PQG's joint standard and recognized the importance of not imposing certain pharmaceutical GMP expectations, such as those relating to process vali- dation, on the pharmaceutical excipi- ent manufacturer. Two separate excipient GMP standards really aren't necessary, however, so over time, it's likely that IPEC membership will steer the industry in the direction of adopting a single, globally recog- nized standard for pharmaceutical excipient GMPs. Qualification of excipient suppliers The traditional means to deter- mine whether an excipient supplier meets appropriate GMP is to con- duct an on-site audit. Most compa- nies resort to paper audits or ques- tionnaires, which are of limited value. In some cases, the excipient supplier won't permit an on-site audit or will limit the audit's duration to a single day, which is also of limited value. In most cases, the pharmaceu- tical company focuses its auditing resources on the APIs and elects to forego on-site audits for some or all of its excipient suppliers. This also isn't necessarily a good outcome. More recently, due to the devel- o p m e n t o f G M P - c e r t i f i c a t i o n schemes, pharmaceutical companies can ensure that their excipient sup- pliers have received certification to a recognized excipient GMP standard. This provides the pharmaceutical company with the assurance that the supplier's GMP program and quali- ty-management system meet an established standard. Several certifi- cation programs are available. NSF runs the Excipient Certification Program (NSF-ECP), an ANSI- accredited program that has been active for a number of years. Excipient GMPs and product lifecycle Excipients must adhere to basic GMP requirements irrespective of the developmental stage of the phar- maceutical product. The GMP stan- dards referenced earlier provide good baseline guidance, and the develop- mental success of a solid-dose prod- uct greatly depends on the consis- tency of the excipient supplied. Suppose, for example, that the supplier of an excipient intended for use in a manufacturing process for solid oral tablets varies the parti- cle-size characteristics through any number of process changes. The impact on the tablet manufacturing process can be significant, such as variations in mixing uniformity, tableting flowability, or tablet com- pression. Furthermore, it's important to rec- ognize that regulatory approval of pharmaceutical products is a compli- cated process, and regulatory agencies expect companies to understand the critical process parameters (CPPs) and critical quality attributes (CQAs) of their products. The CPPs often link to excipient properties. A proactive excipient manufacturer will not only consider meeting GMP expectations but will also provide a comprehensive data set that characterizes the excipi- ent and a description of the control measures in place to ensure the excipi- ent's quality and consistency.

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