PUM NETHERLANDS SENIOR EXPERTS ONLINE TRAINING ON QUALIFICATION AND VALIDATION FOR PHARMACEUTICAL INDUSTRIES IN GHANA

The Food and Drugs Authority(FDA) Ghana has over the years taken various steps including the conduction of routine inspections to improve on the compliance levels of manufacturing companies to GMP and regulatory requirements to ensure the availability of quality products in the country.

The pharmaceutical industry in Ghana has since 2015 been challenged by the FDA to undergo major transformations to enhance their compliance through the 2020 GMP compliance roadmap leading to the construction of new pharmaceutical facilities across the country.

Having identified Premises and Quality Management System (QMS) issues as the main challenges with the existing manufacturing facilities, the FDA in collaboration with other stakeholders such as UNIDO, USP-PQM and PUM Netherlands Senior experts have carried out a series of training programmes through the Drugs Industrial Support Department (DISD) to help address QMS related issues with existing pharmaceutical industries in the country.

In line with this, the DISD of the FDA has over the years employed various capacity-building strategies including classroom training and tailor-made company-specific training programmes to help address QMS related issues with pharmaceutical industries.

Among the major challenges identified through the GMP compliance Roadmap Gap assessment (conducted in 2015 and 2016) was Qualification and validation (Q&V).

To help address this, the management of FDA in collaboration with PUM Netherlands Senior Experts is organizing an online training programme for the pharmaceutical industries in Ghana.

The programme which is scheduled to start on the 7th of February 2022 will be facilitated by GMP Experts from PUM Netherlands Senior Experts and shall cover the following areas:

1. General Qualification and Validation principles
2. Cleaning Validation
3. Q & V of Facilities
4. Process validation
5.Q & V of Equipment
6. Analytical method validation
7.Q & V of Utilities

Each topic shall be delivered in two sessions (two times a week) with a maximum of two hours each day (10 am to 12noon).

The main objective of this training programme is to enhance the understanding of personnel in Qualification and Validation and to enable them meet Q & V requirements for their manufacturing facilities.

The second phase of the programme which involves site visits shall be executed after the online sessions have been completed. The visits shall aim at further supporting industries to address peculiar/pertinent Q&V issues.

Pharmaceutical companies are therefore entreated/ encouraged to take advantage of this opportunity and fully participate in the programme.