• General Specification Requirements
• Specific Specification Requirements
• Technical Specification
• Packaging, Labeling and Storage
• Classification of Nonconformance, Conditions for Acceptance and Rejection

2-1. The LOT of the same number shall match the batch of the same component. The supplier shall ensure evenarrangement in accordance with the specification standards. Where there are any changes in the componentsprovided, the supplier shall notify planned changes to the end user and shall provide technical documents with regard to materials and their mix as well as the certified material test report to the end user. Where the applicable recipe(manufacturing process conditions) affects adversely the quality of a product, the changes to the specification of the applicable product may be rejected.

2-2. The materials used in a stopper shall be harmless to human body and satisfy the EP standards. The components ofa stopper shall not be changed or replaced, and its composition shall be identical to that of the specimen usedin the test. The supplier shall provide a document which specifies that such conditions are required to be satisfied.