SM Mudda, Chairman, Regulatory Affairs Committee, IDMA and Director - Global Strategy (Technical), Micro Labs, emphasises the need to adopt a Quality Management Systems (QMS)-based approach to provide quality medicines
Revisiting the question posed in myarticle 'Pharmaceutical qualityand compliance: Has the 'elephant in the boardroom’ been recognised' in Express Pharma GMP special issue of May 2016, it appears that we have embarked on the quality journey and the industry seems to have corrected its skewed perception related to GMPs. It has recognised the need to go beyond mere ticking the boxes for demonstrating compliance with minimum regulatory standards to adopting a Quality Management Systems (QMS)-based approach and positioning quality as a management function for providing high quality medicines.
A myriad of initiatives have been started by the industry and associations that demonstrate a paradigm shift in the approach towards quality and compliance. The focus clearly seems to be on skill upgradation and capacity building. The IPA Quality Forum is working tobring the large companies together to address quality issues and to jointly develop solutions based on global best practices with a view to help Indian pharma manufacturers to achieve global benchmark in quality. Similarly, the Department of Pharmaceutical (DoP), Ministry of Chemicals & Fertilizers has initiated a nationwide GMP training programme in partnership with IDMA for helping the industry to voluntarily upgrade GMP standards to current global standards. One of the major policy initiatives of Government of India of recent times has been the Prime Minister's Skill India initiative implemented through Life Sciences Sector Skill Development Council (LSSSDC) in pharma industry.
Despite these initiatives, the industry still confronts operational challenges for ensuring ongoing GMP compliance and in implementing successful remediation measures. The common factor in both the cases seems to be lack of adequate skills of personnel in these functions as seen from the observations below.
Consistently inconsistent GMP Compliance- A recurring issue
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