Validation in the Pharmaceutical Industry
Introduction
The Manufacture of pharmaceutical products is a highly complex procedure and is one of the most regulated sectors of any manufacturing industry. The original method of pestle and mortar of yester year have given way to highly advance and complex manufacturing procedures of pharmaceutical products. What was once the preserve of a chemist or pharmacist are now controlled by computerized system. Due to the growth of the pharmaceutical sector fuelled by the demand for existing and new products, the methods of ensuring that all products that are released to the markets are safe ,pure and effective for use by the general public have also developed The regulatory requirement on the sector by such
Up to this point a company could not be prosecuted as was the case of Massergill and Co who were only charged with mislabelling of the product.
With the introduction the Food, Drug and Cosmetic act (FDCA) companies were required to carry out safety testing on their products and would be held accountable for any deaths or injury caused by their products. The goal of the Food, Drug and Cosmetic act was to verify that the food, drugs and cosmetics were pure, safe and effective before been released for general sale. The FDCA also ensure the correct labelling and packaging of products
The Sulfathiazole tragedy occurred as a result of the Winthrop Chemical Company of New York released sulfathiazole tablets which were contaminated with phenobarbital to the market, the result was hundreds of deaths and injuries. The FDA`s investigation revealed serious plant control deficiencies and irregularities in the firm's recall processes. As a result of the Sulfathiazole tragedy the FDA drastically revise their current rules on manufacturing and quality controls. The 1941 sulfathiazole disaster was hailed as the birth of good manufacturing practices
The Septicaemia outbreak of the early 1970`s in hospitals which was caused Enterobacter cloacae of E. agglomerans due to improper sterilising of large volume parenteral resulting in 54 deaths. As a consequence of the FDA investigation which resulted in total product recall and closure of the plant the FDA proposed changes to the GMP`s which resulted in the introduction of GMP`s procedures In 1976 the Medical Device Amendments was signed in to law. This give the FDA greater powers over medical devices. The FDA also Proposed changes to the GMP`s with a strong emphasis on the Sterilisation procedures used to sterilize manufactured products. It was at this time that terms validation and Qualification began to be used within the pharmaceutical sector. In 1978 the cGMP`s rules final established the minimum current good manufacturing practices for the manufacturing process , packing ,storage and transportation of medical products and