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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
29%
Attracting a skilled workforce
26%
Obtaining/maintaining adequate financing
13%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here