The new guidelines cover plastic primary packaging materials intended to bein direct contact with the active ingredient or medicinal product. They are the result of EMEA exercise to update its 1994 guidelines on the use of plastic primary packaging materials in light of the Common Technical Document, which came into force on 1 July 2003 and is designed to make mutual recognition of marketing application dossiers for medicines easier between regulatory authorities around the world.
For the first time, the CTD created a requirement in the EU for information on the container/closure system for a new medicinal
In the new document, the EMEA has detailed the kinds of tests and analyses that should be made on plastic packaging, as well as providing guidance on how the resulting data should be handled and stored. The various studies covered in the guidelines include extraction studies to determine additives within plastics that might be extracted by a preparation or active substance in contact with the plastic, and interaction studies to ensure no substances can leach from a plastic into the contents.
Guidance is also given on toxicological studies that should be carried out on extractables and leachables.
The document notes that the guidelines are intended only for new pharmaceutical products reaching the market. Existing products will not have to meet the criteria. Also, elastomeres and natural and synthetic rubber are not within the scope of this guideline.
The use of plastics in packaging is on the rise in the healthcare arena, driven by increased use of disposable products and more emphasis on child-resistant/senior-friendly and temper-evident packaging, according to market research firm Business Communications Co. Earlier this year BCC released a study indicating that the healthcare sector is driving a 28 per cent increase in the volume of plastic resins used between now and 2009 in North America.