PDA 283.1 Technical Report No. 43: Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing

This live eLearning training course will provide manufacturers and users of glass containers with valuable knowledge related to the quality of glass containers including the types of defects associated with glass manufacture, the development of standardized quality criteria, and sampling plans for use in the quality decision-making process.

The development of PDA Technical Report, No. 43 (Revised 2013), Identification and Classification of Nonconformitites in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing and associated lexicons of glass nonconformities will be described to provide participants with a solid understanding of what is and isn’t in the report and why. Through a series of presentations accompanied by visual depictions of glass nonconformities, participants will be provided with a review of current best practices for identification and classification of visual nonconformities in glass containers. The training course will also present criteria such as the development and use of appropriate sampling plans for incoming inspection of glass containers and the appropriate application of acceptable quality limits for accept/reject decisions. The importance of the partnership between glass manufacturers and the pharmaceutical company using the glass containers in establishing glass container quality specifications will be emphasized.

1. Summarize current best practices for identification and classification of visual nonconformities in glass containers
2. Discuss the development and use of appropriate sampling plans for incoming inspection of glass containers and the appropriate application of acceptable quality limits for accept/reject decisions
3. Describe the appropriate documentation and training for personnel involved in glass in section and disposition decisions
4. Explain the importance of a partnership between glass manufacturers and the pharmaceutical company using the glass containers in establishing glass container quality specifications