RSS Newsfeed  Your shopping cart.
SEARCH

Search in

Keyword

GMP News
08/10/2008
 

What Does a GMP-Compliant Certificate for Excipients Look Like? - New USP General Chapter <1080>

  
Last year, the new General Chapter <1080> Bulk Pharmaceutical Excipients - Certificate of Analysis was included in the USP (First Supplement to USP 30; 1 August 2007). This chapter is orientated towards the recommendations of the American IPEC (International Pharmaceutical Excipients Council) association.

The chapter gives detailed information on how a Certificate of Analysis (COA) for excipients should be structured. It also presents a template for a COA and defines the most important terms in Appendix I.

The main GMP requirements to the manufacturers of excipients have already been described in the USP General Chapter <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients.

The primary competence and responsibility for the COA for pharmaceutical excipients lies with the manufacturer. The excipient user should at least perform suitable identity tests on each batch before releasing the excipient for use in pharmaceutical production. The regulatory requirements define that, for excipients, conformity with all specifications must be checked. A pharmaceutical manufacturer also has the opportunity to take over results from the excipient supplier's COA. However, as a prerequisite he must have ascertained the supplier's reliability (suitable tests, GMP compliance, regular reference analyses, etc.) by means of appropriate auditing and qualification of the supplier.

Neither does the excipient manufacturer have to perform analytical tests for all specifications on every batch of a substance, provided that he can ensure in a different way (validation study results, in-process controls, etc.) that the batch fulfils all specifications before being released. However, in this case, all specification parameters must be checked periodically by means of analytical methods in order to revalidate the reference system. And it must also be indicated on the COA if individual parameters are checked with reduced frequency (e. g. only 1 batch out of 10).

In addition, the USP Chapter lists two kinds of tests (Type A and Type B): Type A tests usually have to be performed on each batch (identity, assay, etc.), whereas Type B tests can be eligible for reduced testing (heavy metals, lead, arsenic, residue on ignition, etc.). The USP mentions four possible examples in which a reduced testing frequency appears to be justified.

Another topic is that of electronic signatures. The text explains under which conditions an electronically signed COA is acceptable.

This new USP chapter will certainly help all pharmaceutical manufacturers in convincing their excipients suppliers that they should provide them with appropriate Certificates of Analysis for their excipients.

Please also see the "European Conference on Good Manufacturing Practices for Pharmaceutical Excipients" conducted by the American IPEC in Munich, Germany, from 1-2 December 2008. You will find more details at www.ipec-conference.org.

Author:
Dr Gnter Brendelberger
On behalf of the European Compliance Academy (ECA)


Conference Recommendations

+++Update:

The information in this article may be outdated. In order to find updated information on this subject (e.g. new developments, training courses) please enter a keyword into the search engine at the top of this page.

You may also use our GMP Guideline Database to search for the current Guidelines.

If you want to receive the latest information about major GMP developments on a regular basis you may want to register for our free GMP Newsletter.
 

 

 

 GMP News by Topics
 Analytical QC
 APIs and Excipients
 Computer Validation
 Counterfeit Medicines
 Good Distribution Practices
 GMP Inspections/Audits
 Pharma Technology
 Quality Assurance
 Sterile / Aseptic / Microbiology
 Validation
 Medical Devices
 Pharmaceutical/Clinical
 Development
 Regulatory Affairs