Essay paper help

Why Validation Is Important In Manufacturing Of Drugs? Essay

Category: Health Sciences & Medicine Pages: 10 Type: Essay Level: Ph.D.
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