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EDITORIAL: QUALITY CONTROL AND QUALITY ASSURANCE

Quality Control of Pharmaceuticals

Reference:
The Journal of Canadian Medical Association, OCTOBER 10, 1964, VOL. 91,NO. 15, By LEO LEVI, Ph.D., F.C.I.C., Ottawa, Ont.,GEORGE C. WALKER, Ph.D.,f Toronto, andL. I. PUGSLEY, Ph.D., F.C.I.C., F.R.S.C.4 Ottawa, Ont.

"Quality Control" by definition is checking and directing the degree or grade of excellence of a Process and the product. To an ethical pharmaceutical manufacturer Quality control implies a detailed system of inspection and control covering the production, evaluation and distribution of every drug bearing his company’s label.

The major purpose of Quality control is to produce medications of superior efficacy, safety and elegance and give assurance to the physician, the pharmacist and the end consumer that the recommended product has a uniform action and acts in the manner satisfactory for the purpose for which it is recommended.

Manufacturing Control of Pharmaceuticals:

Statutory requirements for manufacturing facilities and controls do not by themselves, however, impart high quality to any drug, since quality is a property made up of many elements built subtly into the product- knowledge, integrity and motivation to compound a drug of excellence and choice. Systems of inspection, checking and testing are merely tools to eliminate mishaps as far as is humanly and practically possible. They may be looked upon as a form of insurance provided by the law for the benefit of the physician who prescribes, the pharmacist who dispenses and the consumer who purchases drugs for the alleviation of his suffering and pain.


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