QA/QC In-Depth Focus 2018
In this issue: Anastasia Petropoulu focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines, and Dave Elder looks at method/process capability in terms of QA/QC.
- Quality Assurance / Pharmaceutical Quality Systems in manufacturing medicinal products
Quality Assurance (QA) is a wide concept and covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. The objectives of QA are: to ensure that the prescribed medicine competently provides the desired effect to the person taking it; to protect patients from accidentally being administered an incorrect or contaminated medication; and to ensure medicines comply with the regulation.
- Specifications and method / process capability: two sides of the same coin
Specifications are defined as “a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described”.
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