PQRI Case Study (6): Packaging Line GMP Optimization - Pharmaceutical Technology

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PQRI Case Study (6): Packaging Line GMP Optimization
The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.


Pharmaceutical Technology
pp. 46-48

Risk control

In this case study, risk is reduced by introducing a structured and standardized approach to understand and determine the potential likelihood of system or operator failures and the probability of any resulting defect impacting the final product and end-user. Potential risks which are above a predefined threshold, taking into account severity and frequency of occurrence (the later of which is modified to account for the probability of on-line detection), are considered for elimination or mitigation.

Risk documentation and communication

The risk analysis for the subject case was reviewed by an oversight committee to confirm findings and support risk-mitigation activities. Learnings from the assessment were shared with the firm's other operations that used similar packaging equipment and/or packaging practices. In addition, learnings from the full set of packaging-line risk assessments were captured for consideration in future packaging line design and equipment procurement efforts.

Risk review

As part of the firm's auditing activities, the corporate group responsible for periodic site audits received copies of the risk conclusions and action plans to confirm that corrective actions were deployed effectively. The risk-assessment summaries were maintained at the local site packaging departments for use in future troubleshooting exercises involving deviation investigations or product complaint evaluations.

Ted Frank is with Merck & Co; Stephen Brooks, Kristin Murray,* and Steve Reich are with Pfizer; Ed Sanchez is with Johnson & Johnson; Brian Hasselbalch is with the FDA Center for Drug Evaluation and Research; Kwame Obeng is with Bristol Myers Squibb; and Richard Creekmore is with AstraZeneca.

*To whom all correspondence should be addressed, at


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