Docket Management
Docket: 03N-0059 - Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach
Comment Number: EC -6

Accepted - Volume 1

Comment Record
Commentor Mr. Gregory Gogates Date/Time 2003-03-03 09:43:27
Organization Fasor Inc
Category Company

Comments for FDA General
Questions
1. General Comments This docket considers the use of Product Specialists on Inspection Teams. Might I suggest the use of the existing US Accreditation bodies NVLAP and A2LA technical assessor resources along with their schema as the supplementary source. Both of these groups already have many trained competent persons in the needed areas and can add others as necessary.




EC -6