Compendial Testing

European Pharmacopoeia
United States Pharmacopoeia
Japanese Pharmacopoeia 

Compendial (Pharmacopoeia) testing on the materials used in the manufacture of pharmaceutical containers and closures, or on the final CCS, is a basic requirement for most regulatory submissions around the world.

The FDA-Guidance “Container Closure Systems for Packaging Human Drugs and Biologics” classifies the dosage forms per degree of concern associated with the route of administration and the likelihood of interaction between the packaging and the dosage form. Although different dosage forms will be treated differently in terms of required documentation for the CCS, there is always one basic requirement that should be fulfilled: all materials used in the manufacture of containers, closures or combination devices should be tested according to the current USP compendial tests. These compendial tests are relevant to assess the biocompatibility of the materials because they try to determine the release of toxic compounds under standard conditions in a direct or indirect way:  

 

For certain dosage forms, compliance with the above USP tests – together with compliance with the indirect food additive directives – will be sufficient for an FDA submission. In many other cases (inhalation, parenteral, ophthalmic...), however, more detailed information regarding the potential interaction between the drug product and the container / closure will be requested. 

In the EMEA “Guideline on Plastic Immediate Packaging Materials”, a similar approach is taken. Table 1 stipulates that for non-solid dosage forms, the level of information to be provided can be limited if the material is described in – and complies with the specifications set forth in – the compendial tests of the European Pharmacopoeia, i.e. on the “materials used in the manufacture of containers” (Phar. Eur. § 3.1) and “containers” (Phar. Eur. § 3.2).

 

However, for non-solid dosage forms, “Interaction Studies” are always a requirement although the level of the documentation may vary based upon the route of administration for the drug product. Since only a limited number of polymer types are described in the European Pharmacopoeia 3.1 (i.e. PVC, PE, PP, Polyolefins, Silicone, EVA and PET), users and manufacturers of many other materials used in pharmaceutical primary packaging (e.g. such as PBT, ABS, POM, laminate systems, COP, COC, PS, PU, PC, PEEK, PMMA, PES…) cannot refer to any relevant monographs of the European Pharmacopoeia. For these materials, extraction studies will generally be considered as a requirement. 

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