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As per WHO, Pharmaceutical quality assurance may be defined as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient. QA activities in a hospital or clinic should be comprehensive, spanning the entire supply process from medicine selection to patient use.
Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It’s the main objective to ensure that pharmaceutical products are of the quality required for their intended use. Quality assurance incorporates GMP, GLP and other factors.
It also involves pre-approval inspections, inspections of manufacturers, inspections of drug distribution channels etc. QA involves compilation, validation, documentation to ensure safety of the product.
There is a serious exm of quality breach; In 2010 J&J medicine Tylenol for children (Acetaminophen) was recalled from the market because it was not as per specified quality standard.
FDA said that Tylenol has higher concentrations of active ingredients than specified. Also lawsuit filed against company and they had to pay more than 22 mn $ in 2013 for settlement.
In short, objective of QA is
Protect the Public
Inspire Professional and Consumer Confidence
Safeguard Against Negative Publicity
Improve Production Efficiency
Ensure Compliance
Speaker :
Mr. Chetan Maheshwari
M.Pharm
Senior Research officer,
Development Quality Assurance
Glenmark Pharmaceuticals,
Nashik, Maharashtra
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