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PDA Technical Report No. 43, Revised 2013 (TR 43)Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing:Covering Ampules, Bottles, Cartridges, Syringes & Vials

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The 2013 revision of Technical Report No. 43 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing: Covering Ampules, Bottles, Cartridges, Syringes and Vials provides the building blocks for developing an overall specification for molded bottles, vials and tubular glass containers. This document provides an approach to a quality decision-making process and represents, what the authors, believe to be best practices for identification and classification of visual nonconformities for glass containers. The standardized quality criteria contained in this document are intended as guidance for component manufactures and for incoming inspection at pharmaceutical companies.

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Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Glass Container Conformance Specification Development Process
  4. Glass Nonconformities Lexicons
  5. Conclusion
  6. Appendices
  7. References
  8. Additional Reading

Figures and Tables Index

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