Page 63 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
Summary
Quality is everyone's job, and it should pervade every aspect of pharmaceutical
manufacture and packaging. Quality should not be tested into products, rather,
it must be built in at each step or manufacture.
Quality manifests itself in not only obvious ways, such as during actual
processing steps, but also in diverse areas such as in vendor assurance,
personnel training, internal audits, change management, release for supply, and
QC sampling.
Pharmaceutical manufacturers must integrate the key functions of quality
control (which checks for defects after they have occurred) and regulations or
GMP under the banner of quality assurance. QA is charged with preventing
defects and errors from occurring by overseeing all aspects of producing a quality
product.
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