Specific Requirements on Plastic Packaging Materials for APIs and Solid Dosage Forms?

Among the questions and answers of the European Medicines Agency (EMA) on the quality of medicinal products, there is an interesting question regarding primary packaging materials made of plastic and destined for packaging active pharmaceutical ingredients (APIs) or for solid oral dosage forms.

With regard to the quality requirements, the text says:

The chapters of the European Pharmacopoeia (Ph.Eur.) describing containers and materials for containers do not cover all different types of plastic materials and additives. Therefore, it is not always possible to refer to the specifications of the Ph.Eur. As a consequence, it is not mandatory that all materials comply with the requirements/specifications of the Ph.Eur.

Materials having a different composition and corresponding to a different specification may well be used on the condition that this is justified and agreed upon with the registration authority.

For solid oral dosage forms and for the packaging of solid APIs, the competent working group, i.e. the Joint CHMP/CVMP Quality Working Party, has come to the understanding that synthetic materials fulfilling the requirements of the relevant EU requirements on plastics coming into contact with foodstuffs are considered to be acceptable.

The complete Q&A document can be found here.

Author
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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