Dear Yves,
Good Evening!!!
As per WHO, Primary packing materials, particularly plastics, should
comply with relevant pharmacopoeial and food contact regulations.
For US, Requirements applicable to plastic containers which are
included in USP 661, provide standards for plastic materials and
components used to package medical articles (e.g pharmaceuticals
which includes API).
Hence, Same monograph apply for plastic bags used for storage of API.
It depends on the nature of polymer used in manufacturing of bag.
In EU, for solid dosage form, General description and Specifications
must be provided.
1. General description-For all plastic materials that are used as
immediate packaging material for actives substances
1. the chemical name of the material
2. the chemical name(s) of any monomer used have to be indicated.
2. Specification-When establishing the specifications of plastic
packaging materials being in contact with active substances ,
reference should be made to the appropriate monographs of the
European Pharmacopoeia or the monograph of the pharmacopoeia of a
Member State. When referring to a monograph, compliance should be
demonstrated.
As you mentioned compliance with food regulation, it is applicable
ONLY for non-solid active substances where the supplier can certify
compliance with the foodstuff legislation.
Hope this helps you.
Thanks
Surender
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