With regulatory mechanisms getting streamlined across countries in Africa, inspection and certification of manufacturing sources are becoming an important prerequisite for the product registration process for an importing country.
A delegation from the Ministry of Health DRC visited our Jejuri plant for a routine inspection.
Pharmacist Clement Wuteji Wa Lofembe who is the Chief of quality assurance and quality control and Pharmacist Jean Pierre Bitibiri Bitilon, who is the Chief of registration and authorization of marketing visited the Shalina Plant in Pune, India, on 13th and 14th September 2009 for an Audit, specifically aiming inspection and approval of the Tablet, Capsule and Cream formulation production facilities.
The Audit included a review of various points such as location, plant & machinery, hygiene, quality assurance, various systems, documentation process, self-inspection & quality audits. The inspection went smoothly, which is a tribute to the quality and dedication of our team who ensured that our operation, quality processes & documentation were all well organized and well presented.
The DRC team was pleased with our preparation and professional integrity, and we were presented with a “Clean report” from the delegation.