If your drug product or medical device will be distributed for use in Japan, the container and package system components must meet the Japanese Pharmacopeia (JP) guidelines. While there is some harmonization of test methods in comparison to the standard USP and EP methods, there are slight variation is test steps and regulatory requirements that warrant consultation with a team of experts if you are seeking to meet the JP compendia. The CS Analytical Team has years of experience in the performance of these methods on a variety of container types and constantly reviews JP test revisions and regulatory guidance documents to ensure the most current requirements are being met.
The most common and applicable JP container test requirements are outlined as part of the Japanese Pharmacopeia Section 7 “Test for Containers and Packing Materials”. The following subsections outline general requirements and specific test steps for the following components:
- JP Section 7.01 Test for Glass Containers
The glass containers for injections do not interact physically or chemically with the contained drug product and do not alter any property or quality, can protect the contained drug product from the invasion of microbes by means of perfect sealing or other suitable process, and meet the requirement of the defined soluble alkali test.
- JP Section 7.02 Test Methods for Plastic Containers
It is not allowable for plastic containers holding drug products to interact with the medicant contained therein that can potentially result in the deterioration of its efficacy, safety or stability and to contaminate with microorganisms.
- JP Section 7.03 Test for Rubber Closures
The test requirements are specific to a rubber closure used for a container holding drug product and the rubber closure is in direct contact with the contained medicant. The rubber closure, when in use, does not interact physically or chemically with the contained medicament to alter any property or quality, does not permit the invasion of microbes and does not disturb the use of the contained product.