- Service Details
AMRI provides container qualification testing in accordance with European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) regulations.
- Directory Listing
Pharma Service: AnalyticalCategory: Container Qualification
EP & JP Container Testing are not as common as their USP counterparts, there are a series of European Pharmacopeia (EP) and Japan Ministry of Health (JP) tests specific to container qualification testing. The EP may not be as easily navigated in comparison to the USP due to test procedures being based upon material type and intent of use. The JP is similar in that there is not a defined revision schedule allowing periodic updates and improvements, nor a system in place to provide notice of revisions. When performing or requesting some of these less common, but still regulatory required test, it is imperative to work with an experienced group that understands how the procedure needs to interpreted and implemented. Common EP and JP Container Tests Include: EP 3.1.5 Polyethylene W/ Additives for Containers Parenteral/Ophthalmic, EP 3.1.6 Polypropylene for Containers and Closures For Parenteral/Ophthalmic, EP 3.1.3 Polyolefins, EP 3.1.11 PVC, JP Chapter Plastic Container Testing, JP Chapter Glass Container Testing.
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