Commercialisation · Factory clearance
GMP clearance
MCAZ won’t register a product until its factory is cleared for good manufacturing practice. We work out the cheapest valid route, make sure your site passes it, and run it alongside your filing.
A pending inspection holds up registration.
- MCAZ starts the GMP check when the dossier is filed, so this starts the same day.
- The route depends on the exact production line: a site cleared by the EU for tablets doesn’t count for its injectables.
- MCAZ re-inspects international sites every one to three years, depending on risk.
The three routes
Your factoryRouteWhat we do
In the EU, USA, Australia, Canada or JapanNo inspectionFile proof that the home regulator approved it, inside the dossier.
Same dosage form and production line already cleared by a stringent regulator or WHODesk reviewGather the inspection reports, CAPAs, GMP certificate, annual product quality reviews and batch records into one indexed pack, complete enough that MCAZ doesn’t order an inspection.
A new site in a country without a stringent regulator, which covers most Indian plantsOn-site MCAZ inspection, paid by youRequest it from MCAZ with your site master file and product list, pass on MCAZ’s fee, run a mock audit against WHO GMP, arrange the inspectors’ visit and track the fixes until the site is cleared.
What we do
Collect the site factsEach factory, what is made on which line, every inspection with dates, GMP certificates, site master file and WHO prequalification status.
Check the claims ourselvesAgainst EudraGMDP, WHO prequalification inspection reports and FDA inspection results, so expired or overstated certificates are caught before MCAZ sees them.
Run the routeNo inspection, desk review or on-site inspection, as above.
After clearanceWe track your next re-inspection date so it never catches you out.
What we need from you
- Site master file. Current version, for each site. MCAZ needs it to calculate an inspection fee.
- GMP certificates. Every current certificate for each site.
- Inspection reports. From stringent regulators or WHO, ideally the last three years.
- Corrective-action records (CAPAs). Responses to those inspections and their close-out. Can follow later.
- Annual product quality reviews. For the products going to Zimbabwe. Can follow later.
- Batch processing records. For a recent batch of each product. Can follow later.
How it works
- 1Tell us about itA few questions and your documents. About ten minutes.
- 2Get your quoteWithin one business day. Nothing to pay until you accept.
- 3We do the workWith MCAZ and the people involved, so you don’t have to.
- 4Follow it liveYour own status page shows progress, documents and every deadline.
Pricing
Priced per site, not per product: one clearance covers every product from that site.
Confidential. Your documents are stored privately and never shared without your say.