On 9 October 2003, EMEA (the European Agency for the Evaluation of Medicinal
Products) published a concept paper on the planned revision of the existing
Guidance on Plastic Primary Packaging Materials.
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
You will find the official concept paper on the EMEA website at:
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.
Dr Günter Brendelberger