Revision of the IPEC 'GMP Guide for Bulk Pharmaceutical Excipients' - An important contribution towards drug safety

GMP News No. 174

GMP News
28 February 2002

 Revision of the IPEC
'GMP Guide for Bulk Pharmaceutical Excipients' – 
An important contribution towards drug safety

In Germany there is currently no legal obligation to manufacture bulk pharmaceutical excipients (BPE) in accordance with GMP. On the other hand, however, the pharmaceutical entrepreneurs are responsible for the quality of the BPEs they process. Owing to 'customer pressure' from the pharmaceutical industry, GMP-conform manufacture and distribution of bulk pharmaceutical excipients plays a key role.

But even

the pharmaceutical entrepreneur's obligation to obtain starting materials from qualified suppliers and to inspect the quality of the starting materials have not been able to prevent the distribution and processing - intentional or not – of active ingredients and excipients of inferior quality and their sometimes tragic consequences for the patient. For instance, in Haiti in 1996 some 80 children died after taking paracetamol syrup containing glycerol contaminated with diethylene glycol.

While the manufacture and distribution of medicinal products are governed by law, in many countries there are no legal provisions concerning active ingredients and excipients. With the ICH Q7a 'Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients', which was passed in November 2000, we now have a global harmonized GMP guideline for active ingredients requiring the adherence to GMP rules also for 'Agents, Brokers, Traders, Distributors, Repackers and Relabellers' and therefore covers the entire marketing chain. Nevertheless, this Guideline still has no statutory relevance, for instance, in Europe, where the relevant legal foundations still have to be created.
Therefore regulations for medicinal products and, meanwhile, for active ingredients do exist. But as the case described above shows, excipients may also be the cause of disastrous incidents involving medicinal products.

Against this backdrop IPEC (International Pharmaceutical Excipients Council) was founded in 1991 as an international interest body representing the chemical, pharmaceutical and foodstuff industries. IPEC is an umbrella organization divided into three regional association in the USA (IPEC Americas), in Europe (IPEC Europe) and in Japan (JPEC) and which was founded for the purpose of making an active contribution towards improving the safety and efficacy of medicinal products throughout the world. Within the framework of its activities IPEC is particularly concerned with the harmonization of excipient standards and has meanwhile published several guides for excipients:

  • GMP Guide for Bulk Pharmaceutical Excipients
  • GMP Audit Guideline for Bulk Pharmaceutical Excipients
  • GMP Audit Guideline for Distributors of Bulk Pharmaceutical Excipients
  • Significant Change Guide for Bulk Pharmaceutical Excipients
  • Certificate of Analysis Guide for Bulk Pharmaceutical Excipients
  • The 'GMP Guide for BPEs', which was originally published in 1995, was revised in November of last year to take into account current cGMP requirements pertaining to BPEs and new requirements for the ISO Quality Management System. The revised version of the GMP Guide adopted the ISO 9001:2000 numeration system.

    The 'GMP Guide for BPEs' issued in 1995 serves, for instance, the World Health Organization (WHO) as a guideline for the manufacture of pharmaceutical starting materials for its member states. This Guideline was also adopted in USP 24/NF 19 and in Pharmeuropa, the journal of the European Pharmacopoeia.

    The Guidelines can be obtained from IPEC. The

    contact addresses for IPEC Europe and IPEC Americas are as follows:

    Dr Evert Izeboud
    IPEC Europe
    Tel.: +31-70-320-9894
    Fax : +31-70-320-3759
    E-Mail :

    Mr Alan Mercill
    IPEC Americas
    Tel.: +1-703-875-2127
    FAX: +1-703-525-5157

    Dr. Barbara Jentges,


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