Regulations Governing Good Manufacturing Practices for Medical Products.

These Regulations govern Good Manufacturing Practices of Medical Products. They are for human and veterinary manufacturing facilities and apply to all types of good manufacturing practice inspections of active pharmaceutical ingredients and finished pharmaceutical products that manufacture, import, export, distribute, store, sell and that are used within and outside Rwanda.
The text regulates all aspects concerning the Good Manufacturing Practices of Medical Products: Inspection, Quality Management, management of Personnel involved in the manufacturing, Premises and equipment, documentation, good practices in quality control, contractual arrangements concerning the various aspects of manufacturing, complaints and product recall, financial aspects etc. It also include sections particularly dedicated to the water requirements for pharmaceutical use, the heating, the ventilation and air-conditionings system for pharmaceutical dosage forms, the use of active pharmaceutical ingredients. Also inspections, offences and penalties are treated, in the final part of the document.