The NSF International is one of the U.S. American organisations which create standards for medical and cosmetic consumer goods. The NSF International has recently published a draft entitled "Good Manufacturing Practices (GMP) for Pharmaceutical Excipients". This document provides a comprehensive basis of a QM system for excipients manufacturers. The scope of the draft includes the manufacture and the distribution of excipients. The document sets minimum GMP requirements for the fields of QM system, management responsibility, planning, personnel, infrastructure and manufacture. In the original document the chapter which deals with excipients manufacture is entitled "Excipient Realization".
The authors indicate in many footnotes that this Standard may also be used by Third Party Audit Organisations as a basis for audits in excipients facilities. However, the provisions made in the document should be examined in each individual case to check if they are sufficient to be applied for the excipients. It is the responsibility of the user of the Standard to ensure this in advance.
A finalised document of the NSF Standard draft should soon be published.
A very detailed Standard already exists for the manufacture and distribution of pharmaceutical excipients. Within the framework of the ExcipactTM programme, which was introduced at the beginning of this year, the IPEC has published a document entitled "Certification Standards for Pharmaceutical Excipient Suppliers" which is an official annex of the ISO 9001:2008 Standard. The IPEC document mainly describes the requirements on auditors and Third Party Audit Organisations who perform certification of excipients manufacturers.
A comparison of the IPEC Standard with the draft of the NSF International provides an extensive view over the minimum GMP and GDP requirements for pharmaceutical excipients. Here are the links to both documents:
Please find the current events on GMP for Excipients at www.gmp-excipients.org
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation).