Hooo-Hooo Volume 10, Nr 1 - Page 21

Five years ago we realised that small batches of highly dangerous and highly controlled medicines will never be attractive for Contract Manufacturers. We designed a facility specifically for small batch, dangerous products. In 2014 we commenced with the building process. We obtained advanced technology like fully robotic filling systems to avoid any human contact. Everything is single use, eliminating any cross contamination. The facility is finished and have been inspected by the Pharmacy Council. We obtained a Grade A Certificate from them on Monday 8 February. Now we are just awaiting the MCC inspection for our GMP certificate. This is a massive inspection (Five Days) and is not only on the facility, but all the paperwork, logging, control personnel training, SOP’s etc that goes with it, and I am sure that there will be shortfalls we will have to address after the inspection. This inspection is imminent any day. South Africa is a signatory to the PIC (International) standards and therefor all our facilities should be on World Standards. This is the tough one! Once we have the GMP certificate, we have to keep our first