Running a Marathon in Flip-Flops – Part 2: The Value of Incorporating Prerequisites into Equipment Qualification - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Running a Marathon in Flip-Flops – Part 2: The Value of Incorporating Prerequisites into Equipment Qualification
Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.


Pharmaceutical Technology
Volume 9, Issue 32

Conclusion

Just as a person entering the Boston Marathon can not just arrive and say that they are ready to run without providing the proof that they have the necessary components and training and are up to race standards, an equipment qualification should not be started without having some proof that the equipment is ready for qualification. By incorporating prerequisites into an equipment qualification, you are creating a system for ensuring that the equipment is ready to run consistently and reliably and can pass the testing outlined in the protocol with fewer failures, investigations and retesting.

Of the many benefits to using prerequisites, the most sought after is the potential to save time and money. Having a clear understanding of the benefits and being able to apply them to your facility can ensure smooth, cost-effective qualification efforts.

Jennifer Medlar is a consultant and Nancy Cafmeyer* is a project manager for Advanced Biomedical Consulting, LLC, PO Box 76405, St. Petersburg, FL 33734, tel. 888.614.7177, fax 727.897.9522,

*To whom all correspondence should be addressed.

References

1. N. Cafmeyer and J.M. Lewis, "Running a Marathon in Flip-Flops – Part 1: The Value of Incorporating Prerequisites into Process Validation", Pharmaceutical Technology, April 2008, online exclusive. http:// http://pharmtech.findpharma.com/pharmtech/manufacturing/home/article/detail/505375

2. FDA, "Guideline on General Principles of Process Validation," (Rockville, MD, May 1987). http:// http://www.fda.gov/CDER/GUIDANCE/pv.htm

3. "Current Good Manufacturing Practice for Finished Pharmaceuticals," Code of Federal Regulations, Title 21, Food and Drugs (General Services Administration, Washington, DC, Rev. April 2006) Part 211. http:// http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211


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
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
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 WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
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
Source: Pharmaceutical Technology,
Click here