PDA TR 43 PDF

PDA Technical Report No. 43 (Revised 2023): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for glass containers.

TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. This latest revision (2023) is issued to address evolving standards and container types. TR 43 applies solely to empty glass containers.

The standardized quality criteria in TR 43 are intended as guidance for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies. Five detailed lexicons have been updated which visually illustrate glass nonconformities—one for Moulded glass bottles and vials, and four for tubular glass vials, ampoules, cartridges, and syringes (see Section 8.0 (Appendix). Additionally, defects specific to ready-to-use containers and their categorization are included for use as applicable. Consulting with the appropriate regulatory authorities for agreement on the strategies employed for identification and classification of visual nonconformities of glass containers is always advisable.

These guidelines are not intended to establish mandatory standards for the classification and identification of glass nonconformities but, instead, are intended to provide an overview that complements existing guidelines, standards, and referenced materials. Additional reading has been suggested that can provide greater detail on the various topics discussed in this technical report.