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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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): GMPQMSIVDsNon-complianceRecallRecallsSafetyAdverse Drug ReactionSRPINSAdverse Drug Event

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 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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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): GMPIVDsLicencingMedical devicesClassification Conformity assessmentSafety and performanceFeesClassificationImportersDistributor

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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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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