Saturday, January 19, 2008

The 21st Century QA, Part-I

Few months back when one of my friend called me and announced his joining one of India’s biggest and reputed pharmaceutical company, I felt surprised on his new move. The news was important as my friend who is MPharma is also having good technical knowledge and experience in the areas of quality assurance and regulatory compliance. Relieved from the news that now my dear friend will get settled, at least now in the most reputed company, I congratulated him and wish him a great success in his career move.I recalled this call came to me last February, only when he again called me yesterday to reveal his plans for a next change! Totally aghast from my friends routine announcements of changing the jobs despite of working in good organizations, with good pay-package and at senior levels what made the young guys in keep on changing the jobs quite often.This may be a syndrome or symptoms of growing economy and industry needs, but the way quality professionals are changing their jobs put me in introspection. The reason for this sudden change, which my friend shared with me was that “it was again the same routine job”. He explained – “Though, I joined as Senior Manager, Quality Compliance, I was not given a single person in my group,” he complained. That's the routine affair, I tried to console him.Giving it a serious though - Is really Quality Management loosing its glitter which it received in the mid nineties ? Companies are not interested in fully implementing quality systems or is it becoming increasingly difficult to carry on the agenda of quality?
After carefully reviewing the concept paper released by FDA and ICH on 21st century GMPs or the quality systems it clearly reflects the view points of these agencies for future quality systems management, particularly in pharmaceutical industry. These guidance's describes the comprehensive quality systems model, which, if implemented, will allow manufacturers to operate robust, modern quality systems that are fully compliant with cGMP regulations. The overarching philosophy philosophy articulated in these guidelines is Quality should be built into the product, and testing alone cannot be relied on to ensure product quality. This statement in fact lay down the future prespective of quality systems in the pharmaceutical industry.
Therefore, it is now the onus of quality professionals to realise the visionary statement which emphasizes on building quality into the products rather then working for quality.The rapid growth of pharma industry into the international markets is phenomenal and the participation of this industry into generic business is even more significant.
It is my belief, that with a pace the pharma industry is moving and expanding, many a times it also becomes difficult to manage the entire operations keeping the options open. India had not seen such economic expansion of industry, markets and business till last decade. It's a high time, great time and also time for introspection! We need to think of innovative ideas which are indigenous and compatible to our needs and fulfil the concept of quality by design. Now, it is a collective responsibility of companies and the stalwarts of industry to re-design the Quality Systems and their approach towards quality. We have moved ahead from the earlier stages of maturity. The concepts are not new to the industry and above all their is an immense wealth of experience in managing technology, operations, management and systems.My firend may have other different reasons also to make quick changes in job, but, the after effects of our dialogue and then followed by introspection opened new gateway of ideas giving birth to -quality process re-engineering.In my subsequent writings, I will be giving more information on the GMPs, which is much easier to practice, implement and above all productive !!

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