PDA TR 43

The 2013 revision of Technical Report No. 43 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing 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. The guidelines found in this document are not intended to establish mandatory standards for classification and identification of glass nonconformities; they are intended to be a single-source overview that complements existing guidelines and standards or documents listed in the reference section. For greater detail on various topics throughout this technical report, a bibliography has been provided.