FDA ORGANISES GMP TRAINING FOR LOCAL PHARMACEUTICAL MANUFACTURING COMPANIES
The Food and Drugs Authority (FDA) in collaboration with the Pharmaceutical Manufacturers Association of Ghana (PMAG) has organized a two-day training workshop on the 11th and 12th December 2018 at the Swiss Spirit Hotel for Local Pharmaceutical Manufacturers to address deficiency gaps after a Good Manufacturing Practice (GMP) assessment. This is to ensure that only quality medicines are produced and distributed.
The Chief Executive of the FDA, Mrs. Delese Darko, who opened the workshop, remarked that the training has become necessary after a GMP assessment in 2016 and a much more recent USP-PQM led assessment of four local pharmaceutical manufacturers of antimalarial medicines conducted in 2017, which also revealed a number of deficiencies in the Pharmaceutical Manufacturing processes and facilities.
Mrs. Darko stated that, addressing these deficiencies will require a lot of financial commitment and human resource capacity development which was a major challenge identified during the Corrective Action Preventive Action (CAPA) development phase of the 2020 GMP roadmap by the Drug Industrial Support Unit of the FDA. This is to ensure the protection of Public Health and Safety.
She also said that, the FDA has partnered PQM to provide the needed technical assistance with support from the USAID/PMI taking into cognizance the various challenges in the industry.
The workshop began with a pre-assessment of the participants. They were taken through series of Quality Management Systems, development of Validation Master Plan (VMP), validation protocols and Good Practice in Production and Quality Control by both the FDA and USP-PQM officials. A final post-assessment was done to ensure that the training was effective.