Why Validation Is Important In Manufacture Of Drugs

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.
Introduction
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. Different countries have come up with a harmonized GMP while WHO developed GMP which are used in most developing countries.
2.0: Introduction
2.1: Medicinal Product Terms
According to European Medicines Agency (2000, p.2), 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 (2000, p.2) explains that drug substances does not include intermediates used in the manufacture of such ingredients. ……………….