Introduction to Quality Pharmaceutical industry is guided by very stringent norms and guidelines that are laid down by FDA and the regulatory bodies. It is very crucial for the pharma companies to adhere to these guidelines as the stakes are very high. Pharma companies have to follow Good Manufacturing Practice (GMP) procedures and guidelines laid down by the regulatory bodies to assure a good quality end product. The ultimate aim of these guidelines is to safeguard the health of the patients/ consumers by producing good quality medicines or pharmaceutical products. It is mandatory for the pharmaceuticals to comply with GMP and hence, all the pharma companies put a lot of emphasis on quality. There are 3 approaches to quality: Quality Control Quality Assurance Quality Management. Quality Control is an inspection based approach. QC is used to assure a certain level of quality in a product or service. Quality Control is a process by which the product quality is...
Read MoreParadigm shift in Pharma: Quality by Design (QbD)
Posted by Zinal Bhadra |Apr 28, 2012|1 comment