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.

*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