FDA ensuring medicines meet quality standard
The Food and Drugs Authority (FDA) is taking measures to ensure that all medicinal products on the market are of high and acceptable quality to safeguard the health of the public.
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The Chief Executive Officer of the authority, Mr Hudu Mogtari, said many pharmaceutical products submitted to it for quality tests failed.
He attributed the standard test failures to, among other things, the lack of upgraded skills, including new approved manufacturing technologies and strategies that ensured the quality of all medicinal products.
Process validation workshop
Mr Mogtari was speaking at the opening session of a two-day training workshop on process validation for non-sterile finished pharmaceutical products for local manufacturers in Accra yesterday.
The workshop which has brought together most of the pharmaceutical manufacturing companies, is expected to help industry players build their capacity on process validation of manufacturing processes for medicinal products.
It is being organised by the FDA, under the sponsorship of the United Kingdom’s Department for International Development (DFID).
“The FDA, although a regulator of the manufacture, preparation, importation, exportation, distribution, sale and supply of medicinal products locally, is equally interested in ensuring that industry players employ the highest standards in their sphere of operations to remain competitive both locally and internationally,” Mr Mogtari said.
In that regard, he said, the authority had been organising periodic training programmes on varying subjects in the medicinal products manufacturing value chain for industry players to aid them to meet current codes of good manufacturing practices.
He said that would ensure consistency in the finished products on both the local and international markets in terms of quality, safety and efficacy.
Why process validation
Mr Mogtari said initially emphasis was laid on end-product testing as a quality assurance test parameter. However, industry players now agreed that end-product testing was becoming ineffective in ensuring that medicinal products were of standard.
He said process validation was the analysis of data gathered at every stage of the product design and manufacturing process to confirm that the process could produce a reliable output.
Mr Mogtari called on the public to ensure that all products they consumed had been approved by the FDA to safeguard their health.
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