The World Health Organization (WHO) has facilitated the holding of a training program in Dhaka from 23 to 27 October 2016, to ensure that the regulatory inspection functions of the national regulatory authority, the Directorate-General of Drug Administration (DGDA) of Bangladesh, are performed as per WHO recommended standards. This training program was arranged following identification of some gaps in the process of factory inspections and the compliance process for GMP.
With 20 participants from the DGDA office, 10 observers from private sector manufacturing companies, and 10 additional observers from DGDA, the workshop specifically targeted regulatory inspectors involved in inspections of plants and factories. The “observers” were comprised of technical and scientific staff working in medicine and vaccine manufacturing facilities, primarily from quality assurance departments.
The workshop combined both lectures and interactive discussions which were supported by practical sessions. As regulatory inspection for medicines in general, and vaccines in particular, is a complex process which requires special considerations and expertise to ensure GMP compliance, the workshop conducted a thorough review of the various internationally-accepted quality-control standards.
Hands-on experience in inspection was done through a “mock-inspection” at a factory site in Ashulia, Savar, outside Dhaka city. The trainers were from the WHO headquarters, Geneva, and other internationally reputed agencies working on quality of pharmaceutical products and vaccines. The training workshop was judged to be a success, given that the post-workshop test scores of participants indicated an increase in knowledge of GMP methodology for on-site inspections.