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Why Validation Is Important In Manufacturing Of Drugs? - Essay Example
Validation is an important aspect in ensuring the quality of a product. The manufacture of a medicinal product is a very sensitive process since it entails a final product consumed by human beings. The V model is another measure of validity that compares specifications with the delineated requirements…
Why Validation Is Important In Manufacture Of Drugs?
Validation is required for the manufacture of a medicinal product since this enhances the quality of a medicinal product manufactured. Validation comes through a variety of methods. Use of quality management systems is one of the ways of ensuring validity of a medicinal product since this ensures that the accreditation procedures have been followed to the latter.
The V model is another avenue of enhancing validation of a medicinal product since it stipulates the specifications upon which requirements are measured and evaluated. They will further be discussed in the introduction and discussion of this report.Medicinal products are affected by manufacturing facility used in its synthesis. Enteral, parenteral and topical are the different techniques used in drug administration. These forms of drug administration influence the type of tests that should be done on medicinal products. There are guidelines proposed in the good management practices which define quality control, equipment and facility requirement for manufacture of medicinal products.
According to European Medicines Agency, a drug substance is defined as an active ingredient intended to accomplish a pharmacological activity or a direct effect in the treatment, prevention of disease, diagnosis, cure, mitigation, or to influence the function or structure of the human body. However, European Medicines Agency explains that drug substances does not include intermediates used in the manufacture of such ingredients. ...