Task Force to Work on Glass Defects
by Erik Swain, Senior Editor
Attendees at the Parenteral Drug Association's (PDA; Bethesda, MD) annual meeting learned that a task force has begun to undertake a number of initiatives to reduce glass defects in parenteral packages. The meeting was held December 9-12, 2002, in New Orleans.
Richard M. Johnson, director of information and policy, QCOE-Drugs for Abbott Laboratories Inc. (Abbott Park, IL), told PDA's Packaging Science Interest Group that the task force has allowed glass vendors and pharmaceutical companies to engage in dialogue about how defects occur, how to define a significant defect, and what can be done to minimize them. The task force has about 30 participants so far.
"The pharmaceutical company perspective is that 50-90% of defects are the glass vendor's problem. The glass industry perspective is that the quality of glass has improved, defects are rare, but the expectations of FDA and
the pharmaceutical industry have changed," Johnson told the interest group. "What can be agreed is that no critical defects are allowed--critical being defined as affecting sterility assurance."
In the short term, the task force hopes to standardize the terminology of glass defects, so vendors can notice whether the same problem is given different names by different customers, Johnson said. It may also conduct a benchmarking study of accepted quality levels (AQLs) for glass among parenteral drug manufacturers.
In the midterm, the group would like to publish photographs or drawings of common glass defects and conduct a hazard analysis of common AQLs, he said.
In the long term, a position paper or technical report might be developed. Points to consider, he said, might include reinspection procedures, handling of critical defects, and training of inspectors.
PDA's Visual Inspection of Parenterals interest group is about to publish a technical report on visual inspection procedures, which will include detection of glass defects. But any paper from the glass defects task force would also have to incorporate other inspection methods.