in Tag: Gmp  (clear all)


Found 13 results

Showing 1 to 13

Aerosol Manufacturing (MCC: 4.03, Jun 2003)

Specific GMP guidelines on the manufacture of aerosol – based medicines. Circular 4.03

Related Tags (New Search): GMP

Cephalosporin Manufacturing (MCC: 4.05, Jun 2003)

Specific GMP guidelines on the manufacture of cephalosporin - containing medicines circular 4.05

Related Tags (New Search): GMP

Radiopharmaceutical Manufacturing (MCC: 4.07, Jun 2003)

Pacific GMP guidelines on radiopharmaceutical manufacturing. Circular 4.07

Related Tags (New Search): GMP

Good Pharmacy Practice in South Africa

Related Tags (New Search): GMP,   IVDs

Guidelines for Recall/Withdrawal of Medicines, Medical Devices and IVDs (MCC: 5.07, Nov 2015)

This is a draft guideline incorporating medical devices. Not yet finalised

Related Tags (New Search): GMP,   QMS,   IVDs,   Non-compliance,   Recall,   Recalls,   Safety,   Adverse Drug Reaction,   SRPINS,   Adverse Drug Event

Penicillin Manufacturing (MCC: 4.06, Jun 2003)

Specific GMP guidelines on the manufacture of penicillin - containing medicines circular 4.06

Related Tags (New Search): GMP

Guidelines for Preparation of Site Master File (MCC: 4.08, Oct 2010)

Guidelines for Preparation of Site Master File in preparation for a GMP inspection or for a licence application. 4.08

Related Tags (New Search): GMP,   GWP,   Inspections

SA GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINES (v6, MCC: 4.01, Dec 2017)

Guide to Good Manufacturing Practice for Medicines in South Africa, Circular 4.01

Related Tags (New Search): GMP,   GWP,   PICS

Medicines Control Council: Schedules

Related Tags (New Search): GMP,   QMS,   Licencing

Guidelines on Inspections Involving the GMP Inspectors (MCC: 4.09, Jul 2006)

Guidelines on Inspections Involving the GMP Inspectors. Circular 4.09

Related Tags (New Search): GMP,   Inspections

Guidelines for a Licence to Manufacture, Import Export or Distribute Medical Devices and IVDs (MCC: 16.03, July 2016)

Recommendations or licensing requirements for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices. Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party…

Related Tags (New Search): GMP,   IVDs,   Licencing,   Medical devices,   Classification,   Conformity assessment,   Safety and performance,   Fees,   Classification,   Importers,   Distributor

Guide to Good Manufacturing Practice for Medicines in South Africa (MCC: 4.01, Nov 2010)

Guide to Good Manufacturing Practice for Medicines in South Africa. Circular 4.01

Related Tags (New Search): GMP

Isolator Technology (MCC: 4.04, Jun 2003)

Specific GMP guidelines on the manufacture of products using isolator technology. Circular 4.04

Related Tags (New Search): GMP