FDA trains local manufacturers on Process Validation

The Food and Drugs Authority (FDA) is training local manufacturers of pharmaceutical products on process validation for non-sterile finished pharmaceutical products to help them meet the current codes of Good Manufacturing practices.

The two-day training will help ensure consistency in the manufacture of finished pharmaceutical products to ensure safety, quality and efficacy of their products, placed on the Ghanaian market and the export market as well.

Funded by the Department for International Development (DFID) of the UK, the programme will also provide vital information required for the registration of the pharmaceutical products and thus, reduce the delays associated with the process.

The training programme, which would be in two sections throughout the week for 80 participants across the country, would take participants through areas of process validation protocol: Critical Processes and Parameters, Oral Dosage Forms, Liquid Oral Forms and Cases Studies.

Mr Hudu Mogtari, Chief Executive Officer of FDA, said process validation was critical in manufacturing quality medicinal products, to build the quality into the product at every step of the manufacturing process.

This, he said, will address the identified challenge of manufacturers not using best practices since end products tested did not guarantee the quality of a product.

He explained that, it was mandated by law to assure the regulator that subsequent products manufactured will have the quality as what has been approved and documented in a product registration dossier.

“Process validation is essential part of manufacturing since it assures manufacturers of quality of the product and helps to reduce cost that could result when end product testing fails and manufacturers have to resort to re-working of their products.

He urged manufacturers to avail themselves for such trainings to ensure that all products were of good quality and safe for use.

Mr Jones Ofosu, Coordinator of the DFID Project at FDA, commended DFID for the continuous support and admitted that there has been improvement in the dossier preparation by manufacturers after previous trainings.

He assured manufacturers of periodic trainings for the local pharmaceutical manufacturing industry to enable them to compete fairly with their foreign counterparts and expressed the hope that the workshop would make drug registration easier and faster.