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  1. #1
    Validation Guru
    Join Date
    Oct 2010

    Default PDA Technical Report No.43(Revised)

    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.
    Durga Prasad

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    Durga Prasad


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