Identification and Classification of Deficiencies in Glass Packaging Materials

GMP News
19 December 2007

Identification and Classification of
Deficiencies in Glass Packaging Materials

The Parenteral Drug Association (PDA) recently published the Technical Report No. 43, with the title "Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing". The report has been expected for a while already.

This Technical Report focuses on deviations in packaging materials of tubular glass and moulded glass. The mentioned issues comprise:

  • Sampling (according to ANSI Z1.4 in the US, and respectively the ISO 2859-1 in Europe)
  • Classifications of Deviations (Critical, Major A, Major B, Minor, and N/A)
  • Acceptable Quality Limits (AQL)
  • Descriptions of Deviations and their Classification

For the German-speaking region the evaluation list of deficiencies by the Editio Cantor Publishing House have been a general and established recommendation for controlling various packaging materials for many years - among them are also the lists for containers of tubular and moulded glass. For the American market these detailed recommendations are new, though.

Practical examples for controlling packaging materials will also be introduced in the ECA Education Course "Quality Control and Quality Assurance of Pharmaceutical Packaging Materials" in Barcelona, Spain, from 4-5 March 2008. In workshops various defective packaging materials of glass will be introduced. Participants will have to decide, whether the found defects are critical or not.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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