PQRI Case Study (2): Functional Equivalence for Equipment Replacements - Pharmaceutical Technology

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PQRI Case Study (2): Functional Equivalence for Equipment Replacements
The second in a series of eight case studies from the Product Quality Research Institute focuses on functional equivalence for equipment.


Pharmaceutical Technology
Volume 35, Issue 8, pp. 72-75

Risk documentation and communication

The outputs of this risk-management effort comprise the documented justification for controlled revisions to:

  • Training and qualification curricula for personnel initiating change controls where functional-equivalence will be assessed
  • Equipment change control standard operating procedures that direct the functional-equivalence assessment process for parts replacements
  • Maintenance-systems inventory process-control flow.

Training is required to be performed on these updated documents and training records are periodically audited for compliance.

Risk review

As part of the firm's standard practice for the ongoing maintenance of quality systems, routine audits and document reviews are performed throughout each of the quality systems impacted by this risk assessment (i.e., training, change control, and equipment maintenance). Adverse findings or trends identified during these reviews would provide indication whether the risk assessment needs to be revised.

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.

Risk trainers. NOTE: In assembling this collection of case studies, the authors recognized the benefit of providing industry with additional background on core risk methodologies. Training tools for the application of risk ranking and filtering, FMEA, FTA, and HAZOP are available online with the web version of this article at http://PharmTech.com/PQRIstudies. These tools are meant to facilitate greater familiarity with the risk methodology used in each corresponding case study.

*To whom all correspondence should be addressed, at
.

Reference

1. T. Frank et al., Pharm. Technol. 35 (7), pp. 72–79.


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