New Defect Evaluation List for Rubber Parts
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Recommendation
15/16 October 2024
How to ensure GMP compliant Development and LIfe-Cycle-Management for Drug-Device Combination Products
Defect evaluation lists consist of comprehensive, detailed documents including checklists and instructions for use in the testing of packaging materials and are obligatory for efficient and systematic quality assurance.
The lists are based on GMP Rules, pharmacopoeias (EP, USP, JP), statutory provisions and directives and technical standards EN ISO 2859-1 and DIN EN ISO 15378, ANSI Z1.4 (formerly MILSTD 105) and include a classification of defects, sampling tables and detailed descriptions of testing procedures to facilitate practical work.
The brand new 2019 edition of the bilingual (German - English) Defect Evaluation List for Rubber Parts has been fundamentally revised according to the current state of knowledge and technology and adapted to the defined quality standard including an illustrated four-colour appendix with example images of specific defect characteristics.
Participants of ECA`s Conference on Plastic/Elastomeric Materials for Pharmaceutical Packaging and Production from 25-26 September 2019 in Barcelona, will exclusively receive the Defect Evaluation List for Rubber Parts, New Edition 2019, as a Free PDF-Download!
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