Page 21 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
If manufacturing processes are to be updated,
they may require revalidation as part of
implementation.
Once manufacturing processes are changed, it's
important to continue to monitor the effects of the
change on product quality in order to provide
quality assurance that the change has not had
any adverse effects.
Training
Implementing effective CAPAs often requires
changes to procedures and stair practices.
When changes of this nature occur, it is a
regulatory expectation that supportive training is
conducted so that CAPA permanently fixes the
problem.
Vendor assurance
Supplier or vendor assurance programs are the first steps in ensuring that
quality products are manufactured. It starting materials are sub-standard; the
company would have to rely on the laboratory to find any defects through testing.
As laboratory testing has some significant limitations, QA is required to
implement vendor assurance programs.
QA's role in vendor assurance includes the following activities:
Auditing critical suppliers
Approving or rejecting suppliers whose products may affect qualify
Changing starting material receipt testing plans, depending on the supplier
risk
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