Hygiene Concepts, Cross-Contamination Risks and Cleaning Validation (cGMP)

As a result of the Covid-19 pandemic, many manufacturing sites on the African continent had to scale down their pharmaceutical production due to lockdowns, supply shortages and stock-outs of imported active ingredients and other excipients. These supply shortages show once again the importance of local production of medicines and medical devices in accordance with international standards for the independence and sustainable development of African countries.

In order to resume and continue production - even in times of a pandemic - it is essential that manufacturers are able to comply with local hygiene regulations and provide adequate protection for their workers from the infection with the virus.

Current Good Manufacturing Practices (cGMP) is a system to ensure medicinal products are consistently produced and controlled according to quality standards. Moreover, it is a requirement for fulfilling regulatory requirements, being competitive, and entering international markets. Local manufacturers have highlighted the prevention of cross-contamination and cleaning validation as one of the big challenges in the area of compliance with international Good Manufacturing Practices (cGMP). There is a need for local manufacturers to build up human capacity to produce quality assured medical products and for regulators to strengthen regulatory oversight as many African countries struggle to improve access to high quality essential medical products and strengthen health security.

Goal

The aim of this e-learning course is to provide practical information and knowledge about the risks of cross-contamination and cleaning validation. The course also informs about possible transmission routes of the new corona virus SARS-CoV-2 in the professional context and to recommend hygiene concepts for pharmaceutical manufacturing sites.

The course focuses on the cGMP standards and requirements of the WHO as one of the most important GMPs.

The course participants will be able to critically analyse the cGMP requirements for sanitation, hygiene and cleaning validation and to implement them in their daily work routine in the manufacturing and regulatory environment. The course contents are practiced interactively by the participants in quizzes, tasks and discussion forums.

These capacity building activities in the areas of hygiene concepts, cross-contamination risks and cleaning validation will ultimately prepare participants from pharmaceutical manufacturers and national regulatory authorities better for working in pandemic situations and will make them better equipped to produce and regulate quality assured essential medicines in accordance with national and international standards.