PDA Survey: Glass Quality: 2011 and 2012 Results and Comparison (single user digital version)

Mar 2013
PDA Item Number

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Appropriate standards, glass supplier reliability, and pharmaceutical manufacturer handling and distribution best practices are all necessary elements of maintaining container integrity and product sterility assurance throughout the product lifecycle of sterile injectable pharmaceutical and biopharmaceutical products. Glass packaging quality issues related to defects and/or incompatibilities with finished product over the shelf life have shown pharmaceutical manufacturers and glass suppliers that improvements are needed in glass packaging and glass handling practices throughout the product lifecycle. Industry and global regulatory authorities needed to come together to review issues that resulted in product recalls and global regulatory perspectives and expectations of both the glass supplier and product manufacturer.

The 2011 and 2012 PDA Glass Quality Surveys were conducted to support the PDA/FDA conferences of the same name and years. The conferences focused on the causes for the increase in glass issues and what preventive measures needed to be considered by manufacturers, regulators and suppliers. The issues were having a negative impact on product supply in domestic and international markets; the cost to industry and patients was unacceptable, as were shortages of life saving drugs.

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Table of Contents

Table of Contents:

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  • Introduction
  • Demographics
  • Glass Sampling
  • Glass Suppliers
  • Glass Quality
  • Glass Inspection
  • Post Glass Receipt and Prior to Product Filling Inspection
  • Product Inspection
  • Product Complaints and Recalls
  • Glass Types
  • Japanese Market
  • Ready-To-Use Containers
  • Plastic Containers
  • Quality Oversight