Quality Assurance

Quality Assurance (QA) involves a planned and systematic set of activities implemented to fulfill quality, safety, efficacy and appropriateness of healthcare and Pharmaceutical products. It was experienced by Pharmaceutical and Healthcare industries that Quality Control (QC) and Manufacturing sections were unable to meet the Quality criteria and regulatory expectations which were experienced by increasing compliance failure cases.  Therefore QA educational program at PG level in pharmacy institutes was introduced in India some were in 1990s to take care of increasing regulations and ever increasing regulatory expectation as the Pharmaceutical industry is most regulated among all.

This has led to the introduction of postgraduate QA programs in few Universities. In academics QA programs are said to be the perfect combination of Pharmaceutical Chemistry and Pharmaceutics. In which the first branch is mostly dealing with development of new drugs and modification of the existing/new drugs to solve the problems/ improve drug safety / performance. Second branch deals with development of conventional or novel drug delivery systems (NDDS) to comply with the safety and efficacy of formulated drugs. As QA is a perfect combination of these two branches all these aspects of not only drugs but also of Food, Nutraceuticals, Medical Devices, etc. comes under QA scrutiny for compliance in all respects. In industry QA and QC departments are working in coordination for many aspects as a Quality Unit (QU); QA is playing a major decisive role in QU.

Some of the important designations observed in industry are QA Research Director, QA Audit Manager, Corporate QA Director, etc. highlights the current vital role played, responsibilities deciphered by QA experts for success of organizations. When it comes to warning letters and 483 regulatory observations by FDA; QA dept. is the first choice to handle issues and take care of compliance. It is only QA in industry who translate regulatory expectations for QC, Production, R&D, etc. sections to achieve necessary compliance.

Thus by identifying the current need of a well-structured program MIT introduced the M. Pharm Quality Assurance Program. M. Pharm QA is the pioneering PG branch at MIT since 2006; students work with enthusiasm and zeal, which has led to more than 200 students’ publications and various drug technology patents with students as co-applicant.

All Pharmacy PG scholars and QA scholars in particular at MIT WPU are at advantages as large no options are available to choose research topics such as synthesis of prod drugs, conjugates, formulating conventional and NDDS dosages forms, evaluation of quality, safety and efficacy aspects of various drug, Food, Nutraceuticals, Herbals as well as drug- excipients, Drug –drug and Food – drug interactions. Typically facilities available for research are excellent. Students have access to a cell biology facility, well equipped instrument room for manufacturing of trial batches, CPCSEA approved animal house, and a well equipped analytical instrumentation facility in the institute. Students are at their liberty to choose the research guide of their interest. Students can select one principle guide and one more teacher as co-guide so that he/she can work with ease on multidisciplinary research projects.

Extensive academic coverage is achieved with subjects spread over two semesters in the first year. First semester offers four theories and one practical subject; theory subject offered for first sem. are i. MPAT, ii. Quality Management Systems, iii. Quality Control and Quality Assurance iv. Product Development and Technology Transfer. Second semester also includes four theories and one practical subject. These subjects are i. Hazards and safety Management ii. Pharmaceutical Validation, iii. Audits and Regulatory compliance and iv. Pharmaceutical Manufacturing Technology.

The job opportunities are ample in various sections such as Pharmaceuticals Manufacturing, Formulation Research, Analytical Research, Quality Assurance, Biotech industries, Food Industry, Cosmetics, Veterinary Pharmaceuticals, etc. Successful QA candidates will find employment in these industries in sections such as Regulatory Affair, Quality Assurance, Quality Control, Documentation Officer, Medical Information Associates, in Pharmacovigilance, etc. Students can opt for academic career in educational establishments.