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, QA, QC and professionals from functions having direct or indirect impact on the quality of products from February this year.
NSF International UK (previously David Begg Associates) is a global leader in education for the pharma industry.
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).
IDMA has collaborated with NSF because the latter has extensive knowledge of the India pharma industry and over 40 years global experience with offices in India, USA, China, the EU and UK. Its team of experts include ex regulators from MHRA and USFDA and professionals with 35 years plus hands on experience. The UK based NSF is the global leader in providing ‘Qualified Person’(QP) training across the EU also.
AAPQM comprises five intensive modules each of 4 days duration scheduled every 8 weeks. Each module will be assessed by written examination. Successful candidates will be awarded an internationally recognized Certification from NSF and IDMA.
Introduction of APPQM is a major breakthrough for Indian pharma industry as technical and QA professionals in India are trained in GMP compliance only through experience and therefore need a formal education in pharmaceutical quality management of international standards. The programme encompasses ICH, WHO And USFDA requirements and best industry practices
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.
As there was no formal training program in India on taking corrective measures timely raised by regulatory authorities like US FDA, UK MHRA and other regulators on GMP deficiencies, Data Integrity issues among others, IDMA, 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.
Acharya Institute of Technology, Bengaluru has been finalised as the venue for the training programme with local administrative support of IDMA Karnataka State Board. The course is expected to start after a pre-launch event in Mumbai on 16 February, 2017.
The event will witness speeches and presentations from NSF and IDMA officials on the day of pre-launch event. After the welcome address by S M Mudda, chairman regulatory affairs committee, IDMA and programme coordinator, a presentation on IDMA initiatives for ‘Building Brand India’ by S V Veerramani, immediate past national president, IDMA, followed with address by Deepnath Roy Chowdhury, national president, IDMA, Mumbai, O Sadhwani, joint commissioner Maharashtra FDA, Dr K Bangarurajan, Deputy Drugs Controller (I) CDSCO, West Zone Mumbai, Sudhanshu Pandey, joint secretary, Department of Commerce, Ministry of Commerce and Industry, Government of India and two presentations on advanced programme in PQM by Martin Lush, president NSF will be the key highlights of the pre-launch event.