Drugs being a very important component of healthcare, these need special attention especially with respect to quality, efficacy and safety. This has always been a matter of concern from the consumer point of view. The quality control concept basically meant that the quality of the product conformed to the predetermined standards as given in the pharmacopoeia. But the concept was not enough as thereafter the concept GMP emerged in the 1960s in USA. It was however the WHO who played a major role in bringing awareness to the manufacturer of the drug product and national drug regulatory authorities through its certification scheme. The setting of global standard is required by WHO constitution. One of the organization function is that it should “develop, establish and promote international standard with respect to food, pharmaceutical and similar products”.
Responsibility of assuring product quality belongs principally to quality assurance personnel but involves team effort. The manufacturer fulfills his obligation to the consumer by following good manufacturing practices, which ensure that a product consistent high quality is manufactured by him every time. Good manufacturing starts from the time raw material enters the factory and continues into the final dosage form and takes care that it is delivered safely into the hands of consumer.
In the recent past pharmaceutical manufacturing organizations world over have devoted a great deal of effort (resources) to ensure compliance with cGMP guidelines issued by licensing authorities. The Indian pharmaceutical industry in particular has demonstrated remarkably its ability to comply with the stringent requirements of regulatory authorities like the USFDA and UKMCA, etc. Still except for multinational companies and a few other pharmaceutical companies, GMP did not percolate to a large number of medium and small-scale pharmaceutical companies.
In the view of change which is taking place Indian pharmaceutical industry; to stand in the global market, Quality assurance department is set to help the students to learn and understand the concepts of cGMP, GCP, GLP, etc. and implement them successfully to industry.
Thurst area:
- Validation of equipments, process.
- Analytical method development and validation
- Formulation development
- Documentation
Department Staff:
- Dr. M C Damle (Professor)
- Mr. Shrikant Morkar (Assistant Professor)
Support Staff:
- Mr. Chingle R. Y.(Lab Assistant)