in Tag: Gmp (clear all)
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Aerosol Manufacturing (MCC: 4.03, Jun 2003)
Specific GMP guidelines on the manufacture of aerosol – based medicines. Circular 4.03
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Cephalosporin Manufacturing (MCC: 4.05, Jun 2003)
Specific GMP guidelines on the manufacture of cephalosporin - containing medicines circular 4.05
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Radiopharmaceutical Manufacturing (MCC: 4.07, Jun 2003)
Pacific GMP guidelines on radiopharmaceutical manufacturing. Circular 4.07
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Penicillin Manufacturing (MCC: 4.06, Jun 2003)
Specific GMP guidelines on the manufacture of penicillin - containing medicines circular 4.06
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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
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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
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
Guidelines on Inspections Involving the GMP Inspectors (MCC: 4.09, Jul 2006)
Guidelines on Inspections Involving the GMP Inspectors. Circular 4.09
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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
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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
Isolator Technology (MCC: 4.04, Jun 2003)
Specific GMP guidelines on the manufacture of products using isolator technology. Circular 4.04
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