Comments sought on new EU GMP guidelines for biologicals
Document to provide advice on handling biological active substances prior to being rendered sterile
The marathon process to frame EU guidelines on good manufacturing practice for making biological medicinal products, such as vaccines and allergen drugs, is nearing its conclusion. The European Commission has now launched a second round of public consultation, asking the pharmaceutical industry for its views before a final text emerges for approval by the European Commission.
The process of drafting started in 2005 and, according to a Brussels note, the latest version includes ‘significant changes’ following a first consultation in 2008. The guidance will especially give advice on the manufacture of new product types such as transgenic-derived medicines and advanced therapy medicinal products.
It will be incorporated as an annex to the EU’s general Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and will provide detailed advice and information on handling biological active substances prior to being rendered sterile; and subsequent manufacturing steps. The guidance notes that for some products, such as cell-based products, ‘all manufacturing steps need to be conducted aseptically’.
The annex also aims to help categorise, and hence regulate, these products: it ‘provides guidance on the full range of medicinal substances and products defined as biological.’
The biological stages of manufacture of antibiotics are also covered by the annex, although other issues related to these medicines are dealt with by other annexes, as are medicines made from human blood, plasma and non-transgenic plants. Advice covers issues such as personnel, the use of animals, documentation, operating cell banks and seed lots.
Comments should be submitted to adm-gmdp@ema.europa.eu and ENTR-GMP@ec.europa.eu, before the deadline of 15 July.