To help quality control heads of Indian pharma companies enhance audit-readiness, the Indian Drug Manufacturers Association (IDMA) and the UK-based agency NSF International have collaborated to jointly start Advanced Programme In Pharmaceutical Quality Management (APPQM) for professionals in R&D, manufacturing and quality control.
NSF International UK (previously David Begg Associates) is a global leader in education for the pharma industry. Spearheaded by S M Mudda, chairman, Regulatory Affairs Committee, IDMA conceptualised the training programme for QA personnel to train and recognise them as qualified persons on the lines of courses conducted in UK by NSF, UK.
Technical and QA professionals in India are trained in GMP compliance mainly through experience and need a formal education in pharmaceutical quality management of international standards.
India is the world’s third largest pharmaceutical generics producer with the highest number of FDA and MHRA GMP-approved manufacturing plants outside the US and Europe. The challenge of remaining in GMP compliance continues to be the main concern and regulatory requirements continue to become more stringent and rigorous.
While Sixty-four percent of companies say a shortage of skilled staff is curtailing their growth, according to global consulting firm Deloitte, there is also an urgent need for more effective training, coaching and mentoring to remove fear and empower pharma professionals, according to Dr. Azaj Hussain, former US FDA Deputy Director of the Office of Pharmaceutical Science.
This program will help quality control heads of Indian pharma companies enhance audit-readiness and implement compliance in areas of good manufacturing practices (GMP), quality assurance, documentation, data integrity and quality management system (QMS). The programme encompasses ICH, WHO and US FDA requirements and best industry practices
In addition to module-specific content, participants will be provided with a deep understanding of simplification, risk-based decision making and advanced problem solving skills. Participants will receive practical instruction on the leadership and communication skills required to add value to their organisations and to successfully interact with regulatory agencies in the US and EU and other key stakeholders.
NSF has trained regulators from eight regulatory agencies including those in the EU and USA. Respected by regulatory agency and industry associations, NSF has excellent relationships with IDMA, ISPE, PDA organisations and US FDA, WHO and EU regulatory authorities. With offices in Delhi, NSF has an excellent understanding of Indian culture and the Indian pharma industry, gained over the last 30 years.
The programme will not only help understanding of global regulatory requirements in the wake of resurgence of quality issues over the past few years but will also reduce repeat deviations by 78 per cent in just 6 months, reduce ‘Human Error’ deviations by 67 per cent in 12 months, help achieve 99 per cent ‘Right First Time’ at product release and also help achieve zero regulatory observations following audit.
The programme is aimed at reducing the frequency of customer complaints and quality non-compliances, drastic simplification of documentation systems to reduce lead times and procedural non-compliances, radical simplification of quality systems to reduce human error events, designing and implementing a simple process for the identification and investigation of out-of-trend results, reducing the frequency of invalid out-of-specification results to speed up batch release and reduce levels of work in progress, improving laboratory productivity by eliminating no-value-added laboratory processes and simplification and harmonizing of sops to reduce the burden of documentation as well as procedural non-compliances.