On 25 February 2004, EMEA published the draft version of the Guideline on
Plastic Primary Packaging Materials for commenting by the industry
until the end of August 2004. In the future, this guideline will replace
the former Guideline 3AQ10a.
It is the aim of this guideline to define
standard procedures for the submission of data in the procedure for a
marketing authorisation for plastic primary packaging materials used for
the storage of active pharmaceutical ingredients and finished drug
products.
The guideline is divided into the following chapters:
- Introduction
- Location of documentation to be provided in the marketing
authorisation application
- Data to be submitted
- Extraction studies
- Interaction studies
- Toxicological information/documentation
Another interesting feature are two appendices that list in the form of
decision trees which data have to be submitted with regard to plastic
packaging materials for active substances and for drug products
respectively. In the case of drug products, the first distinction is made
between oral use and non-oral use. The next question is whether the drug
products are solid dosage forms or others.
Furthermore, the guideline indicates the data that have to appear in a
specification for a plastic packaging material if the material is not
described in the European Pharmacopoeia.
This new draft by EMEA is certainly a very important guideline for all
those who have to do with plastic packaging materials.
You can download the draft guideline if you click here.
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
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