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. A drug substance is affected by the manufacturing facility used in its synthesis where Balogh and Corbin (2005, p. 56)observe that drugs produced in facilities that do not compile with good manufacturing practices may have toxic materials which may be introduced by non clean air, or low quality water. In addition, cross contamination may happen from other chemicals being used in facility. Viruses and bacteria may also contaminate drug substances where they could be introduced by operators working in the manufacturing facility. A drug product refers to a finished dosage form such as capsule, tablet, or solution that contains a drug substance. A drug product is a dosage form in the final primary packaging intended for marketing. Packaging is important to protect the drug product against adverse external influences that can change the properties of the product as observed by Bhat (2000, p 3). Packaging is also used to help in the identification of the product and protect the drug product from physical damage. There are various techniques applied in drug administration. (Lees, Cunningham and Elliott, ,2004, p. 396) explains that drug administration via the gastrointestinal tract also referred to as enteral or enteric administration. This form of administration includes drug administration through either the mouth or rectum where the drug does into the intestines. Parenteral drug administration is where the drug is administered by other routes other than the digestive system. This can be either through intravenous, intra-arterial, intramuscular, or intracerebral. On the other hand, topical administration is when a substance is applied directly on the place where the action is required. 2.2: Good Manufacturing Practices (GMP) To ensure the efficacy and the safety of drug products consumed, pharmaceutical companies are required to observe some manufacturing practices. Good manufacturing practices are defined as the ways and systems that pharmaceutical companies need to adapt to in manufacturing, quality assurance, manufacturing and quality systems testing of drugs, diagnostics reagents, medical devices and foods. GMPs set out guidelines on the aspects that can have an effect on production and testing of the quality of a product. Different countries have