QUALITY ASSURANCE AND QUALITY CONTROL


Overview

It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.


Scope

Some pharmaceutical industries have both QA and QC departments, are considered as same unit but most of the industries considered them as different units and contain different areas for both. QC is responsible for checking of all aspects related to products. For ex, QC of aerosol involves checking of propellant, checking of container, valve, quality and life span active concentrate etc. And QA of same is checking of products which are passed by QC department. They will check all the limits and equations passed by QC.
In pharmaceutical industries, QA professionals are most welcomed with attractive salary. The main thing is knowledge of analytical skills and experience of working with any pharmaceutical industry is required. It is highly responsible work. We already know that one small mistake can make numerous losses.


Future Prospects

In the present world there are number of pharmaceuticals companies, hospitals and nursing homes all over the globe exhibits rapid growth of the pharmacy sector. Pharmacy offers reasonable job opportunities for their graduates in terms of business or by opening their own business. The consumption of medications and health supplements is increasing worldwide every year. Worldwide sales of medicines reached 1.08 trillion USD in 2011 (an increase of 7.8%over the previous year) and are expected to reach 1.5 trillion USD by 2020 as per the Price Water Cooper report on the pharma industry. To cope with this increasing demand for pharmaceutical products, the number of companies producing the same has increased.
In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and EU. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market.


Program curriculum

We provide Pharma quality assurance and quality control course in two levels as Professional Designation for undergraduate students and Advance PG Program for Graduated Students. The details of the courses are as below:




Job opportunities

Along with an increase in number, over the last 10 years there has been a number of mergers and acquisitions of Indian and MNC pharmaceutical companies for leveraging their strengths resulting in increasing the profitability and effectiveness of the pharmaceutical manufacturing. Today there are a number of Indian companies in close tie ups with global MNC pharma companies for developing, producing and marketing pharmaceutical products.
In order to ensure quality, safety and efficacy of products, every country has their regulatory agencies which regularly review and inspect the company's manufacturing sites where these drugs are manufactured. Additionally there are internationally recognized regulatory bodies whose approval is required before the drug substances and drug products can be exported and sold in the respective countries. To name a few: US FDA in USA, MHRA in UK, Health Canada in Canada, TGA in Australia, MCC in South Africa, ANVISA in Brazil, COFEPRIS in Mexico, the WHO etc.



Industries associated with Pharma Quality Assurance and Quality Control


♦    Baxter BioPharma Solutions
♦    Lyophilization Technology, Inc.
♦    Aurobindo Pharma
♦    Abbott Laboratories
♦    Cipla
♦    Cadila Healthcare
♦    Biocon
♦    Dr. Reddy's Laboratories
♦    Celgene
♦    Bausch & Lomb
♦    Lupin Limited
♦    Novo Nordisk
♦    Novartis
♦    Johnson & Johnson
♦    Wockhardt
♦    Unichem Laboratories
♦    Sun Pharmaceutical
♦    Orion Pharma