The Indian Drug Manufacturers Association (IDMA) and UK based agency NSF have collaborated to start qualified pharmacists course from April this year to 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 course which is being conducted by NSF in UK is widely recognised by UK MHRA to conduct audits for quality assurance. UK based NSF also trains UK MHRA personnel in the areas of GMP, quality assurance, data integrity and QMS.
The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the United Kingdom (UK).
Says IDMA Chairman S V Veerramani, “Through the qualified pharmacists course, we will produce 30 qualified pharmacists initially. The course is spread over 40 modules for a period of 10 months. The candidate will devote 4 days in one month to cover 4 modules with one module every day. This will enhance the audit-readiness and quality compliance of the QA professionals in the country.”
The Department of Pharmaceuticals (DoP) is also collaborating with IDMA in organising seminars and workshops jointly aimed at imparting technical skills and improving regulatory and quality standards of manufacturers. DoP has agreed to part fund all technical workshops for which IDMA has sought their support during the year. “We provided them a list of workshops to be conducted with the support of our state boards. We jointly organised GMP workshops at Chennai, Kolkata, Ahmedabad, Haridwar, Bengaluru and Mumbai. Similar workshops are also scheduled to be held at Nashik, Baddi, Indore and other places. The department has also actively supported our seminars on goods and service tax held at Mumbai, Kolkata and Chennai,” Veerramani added.
Union health ministry has also been working on harmonising provisions of GMP vis-a-vis WHO GMP and is also planning to organise training programmes for upgradation to WHO-GMP for the SME industry at Chennai, Kolkata, Mumbai, Ahmedabad and Hyderabad.
Source: Pharmabiz.com
