Challenge may be to R&D staff, not just QA/QC, says Mallinckrodt exec.(PAT)

Validation Times | October 1, 2003| | Copyright

PHILADELPHIA -- FDA has been trying to get the pharmaceutical industry to implement PAT as a means of applying real-time QA/QC instead of testing and validating batches after the fact, but the real challenge to PAT acceptance might not just be with QA and QC staff, but R&D personnel.

So says Vishal Gupta, Ph.D., a senior research investigator at Tyco Healthcare Mallinckrodt in St. Louis, who told CPT's conference here Oct. 1:

"It's going to be a big learning phase for all of us, understanding how exactly R&D can apply PAT, and it will be important that ...

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