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categorization, but GAMP is historically based on software, while USP <1058> is based on the calibration requirements and complexity/ usage of the instrument. One problem is that when the FDA first implemented its guidance for pharmaceutical manufacturing validation in May 19875
many organizations applied the principles to laboratory instrumentation.
Unfortunately, the process validation principles defined in Ref. 5 were interpreted and diversely applied to laboratory instruments by pharma- ceutical companies, instrument manufacturers and consultants. In many laboratories, this has resulted in poor understanding of what is re- quired to implement new instruments, which can delay return on investment of result in compliance risks.
The fundamental importance of laboratory compliance means that it must be a core stra- tegic priority for laboratory management. However, it is not uncommon for day-to-day job pressures and business priorities to limit strategic compliance thinking to being reac- tive, rather than proactive; this leads to those instances in which “inspection readiness” is not a strategic priority, but the work done just before the audit.
References 1. Smith, P.A. Strategies for successful ana-
lytical technology transfer. Int. Pharm. Ind. Winter 2013 5(4).
2. Federal Food, Drug, and Cosmetic Act (FD&C Act);
http://www.fda.gov/regula- toryinformation/legislation/FederalFood- DrugandCosmeticActFDCAct/
default.htm; accessed Feb 2015.
3. GAMP® 5. A Risk-Based Approach to Com- pliant GxP Computerized Systems; http://
www.ispe.org/gamp-5.
4. USP General Chapter <1058> Analytical Instrument Qualification.
5. FDA Guidance for Industry—Guidelines on General Principles of Process Validation, May 1987.
Paul Smith is Global Strategic Compliance Pro- gram Manager at Agilent Technologies and has been working in laboratory compliance consul- tancy for the last 12 years. Within his Agilent role, Paul works with laboratories and organizations across a range of industries, as well as monitoring and sharing laboratory compliance trends across those industries. Prior to his compliance consul- tancy work, Paul worked in a variety of quality, management and analytical roles over 17 years in the pharmaceutical industry.
AMERICAN LABORATORY • 11 • MARCH 2015 Find out more at
www.metrohmusa.com/technology Laboratory Process
Spectroscopy
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