Adoption of standards for blood products in the Addendum 1995 to the British Pharmacopoeia (BP) 1993

The revised monographs of the European Pharmacopoeia (EP) for the following blood products are now included in the Addendum 1995 to the BP 1993:

• Plasma for Fractionation;
• Antithrombin III Concentrate;
• Dried Factor VIII Fraction; and
• Fibrin Sealant Kit.

The EP monograph for Plasma for Fractionation was adopted in the UK (and in all other EC countries) effective from 1 November 1994 and the other three monographs listed above were similarly adopted in the EC countries from 1 January 1995.

In view of the commitment to harmonising standards for therapeutic goods in Australia with those in Europe and the importance attached to the quality of blood products, the above monographs were adopted to take effect in Australia from 30 March 1995, after consultation with the Therapeutic Goods Committee, industry bodies and relevant sponsors. A Gazette Notice to this effect appeared in the Commonwealth Gazette: No. GN 12 of 29 March 1995.

The other monographs included in the Addendum 1995 will be adopted at a later date.

New editions and addenda

The 1995 Addendum of the British Pharmacopoeia has been published and is to take effect in Britain from 1 July 1995. It is to be expected that the Addendum will be gazetted as taking effect in Australia soon afterwards.

The Addendum contains a number of new monographs which will become standards under Section 10 of the Therapeutic Goods Act. Sponsors should review the Addendum and its application to supplied products.

Supplementary Chapters are an interesting innovation in the new Addendum. While not a standard, these describe the intention of the Commission in certain areas, dissolution for example, and should be of interest to sponsors.

Fascicule 18 of the second edition of the European Pharmacopoeia was published in 1994 with effect in Europe from 1 January 1995. The Fascicule includes 12 new general methods in the biological field. Fascicule 19 is to be implemented on 1 January 1996 and will contain 93 new and 72 revised texts.

The 23rd Edition of the United States Pharmacopoeia (USP) has been published with an effective date of 1 January 1995. While not an official standard in Australia it is a valuable reference and is preferred in some countries in the region. The USP has made several thousand changes, including the tests for heavy metals and loss on ignition, as part of its commitment to international harmonisation.