Excipient standards – Ask an Expert


Q: What standards should my excipient supplier meet for excipient quality?


A: Jim Morris, NSF Health Sciences, a division of NSF International says:


Historically, excipient manufacturers have relied on the International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group’s (PQG’s) Joint IPEC-PQG Good Manufacturing Practices (GMP) Guide for Pharmaceutical Excipients [1]. The two organizations issued this guidance in 2006, and it was the product of a significant amount of work by IPEC’s members. It provides a great baseline; the industry, however, has moved on.


Excipient manufacturers should reference either ExciPact’s Certification Standards for Pharmaceutical Excipient Suppliers 2017 [2] or NSF International (NSF), IPEC, and American National Standards Institute’s (ANSI’s) NSF/IPEC/ANSI-363-2016 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients [3]. Both are contemporary standards, closely aligned because the organizations based them on IPEC and PQG’s joint standard and recognized the importance of not imposing certain pharmaceutical GMP expectations, such as those relating to process validation, on the pharmaceutical excipient manufacturer.


Qualification of excipient suppliers

The traditional means to determine whether an excipient supplier meets appropriate GMP is to conduct an on-site audit. Most companies resort to paper audits or questionnaires, which are of limited value. In some cases, the excipient supplier won’t permit an on-site audit, or they’ll limit the audit’s duration to a single day, which is also of limited value. In most cases, the pharmaceutical 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 development of GMP certification schemes, pharmaceutical companies can ensure that their excipient suppliers have received certification to a recognized excipient GMP standard. This provides the pharmaceutical company with the assurance that the supplier’s GMP program and quality management system meet an established standard. Several certification programs are available. NSF runs the Excipient Certification Program (NSF-ECP) an ANSI-accredited program that has been active for a number of years.


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