The concept paper refers to the Note for Guidance on Plastic Primary Packaging Materials (3AQ10A). This guideline has to be revised in order to comply with the new CTD (Common Technical Document) format for the procedure to obtain a marketing authorisation. At the same time it has to be judged whether the requirements mentioned in the text are still state of the art. After all, the guideline dates back to 1994 and is thus almost ten years old.

In this revision process, the following changes are to be made:

• The new regulations are meant to apply also to plastic primary packaging materials for APIs.
• Requirements that are not specific to plastic packaging materials, but refer to all sorts of packaging materials, are going to be omitted.
• The references to pharmacopoeial monographs and requirements for food-stuff are meant to be updated.

This guideline is planned to be released in December 2003 for a six-month consultation phase.

You will find the official concept paper on the EMEA website at:
http://www.emea.eu.int/pdfs/human/qwp/481503en.pdf

During the ECA Education Course "Quality Control and Quality Assurance of Pharmaceutical Packaging Materials," to be held in Copenhagen from 17-18 March 2004, one lecture deals in detail with the regulatory requirements on pharmaceutical packaging materials. The topics include the EU guideline mentioned above as well as all current FDA requirements, e.g. the FDA Guidance for Industry "Container Closure Systems." Please click here for the complete invitation programme.