Parallel to the USP, the European Pharmacopoeia (EP) prescribes a series of qualification tests specific to container and package systems for medicinal drug products that will be distributed and used throughout the EU territory. Selection of the required methods specific to your package system requires knowledge of the materials of construction, how it will be used and the type of product that it will store. In most cases, due to the lack of harmonization between the USP and EP, satisfying global qualification requirements is most readily attained by full completion of both the USP and EP methods in their entirety. Common and routine EP container testing methods include:
- EP 3.1.5 Polyethylene with 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
- EP 3.2.1 Glass Containers for Pharmaceutical Use
- EP 3.2.9 Rubber Closures (Elastomeric)
- EP 3.1.9 Silicone Elastomer
- EP 3.1.15 Polyethylene Terephthalate for Containers for Preparations not for Parenteral Use
- EP 188.8.131.52 Plastic Containers for Aqueous Solutions for Infusion
The complexity of the interpreting the European Pharmacopeia testing requirements for container systems can be starkly different for someone used to routinely reviewing and implementing the USP test methods. More precise attention is paid to the actual materials of construction coupled with the type of product it will store, though recent USP chapter revisions are beginning to replicate this approach, most notably USP <661.1>.
The CS Analytical Team collectively brings more than 70 years of experience interpreting and performing EP testing specific to container and package systems. The laboratory also inventories the unique required chemicals and solutions, including EP reference standards, so that testing can begin immediately thus preventing report issue delays. With all work being performed in a cGMP to strict quality standards, you can be sure that your qualification testing work with meet both the FDA and EMA stringent review requirements.