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