Evaluation of Quality and Interchangeability of Medicinal Products. Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community Dar Es Salaam, Tanzania Date: 10 to 14 September 2007.
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Evaluation of Quality and Interchangeability of Medicinal Products
Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community
Dar Es Salaam, Tanzania
Date: 10 to 14 September 2007
Finished Pharmaceutical Products
3.1.Manufacturing and marketing authorization
3.4.Sites of manufacture
3.6. Manufacturing process controls of Critical steps and intermediates
3.7.Process validation and Evaluation
3.8. Specifications for excipients
3.9. Control of the FPP
3.10. Container/closure system (s) and other packaging
3.11. Stability testing
3.12. Container labelling
3.13.Product information for health professionals
3.14.Patient information and package leaflet
3.15.Justification for any differences to the product in the country or countries issuing the submitted WHO-type certificate(s)
- Precise any overage,
- Precise quantity adjustment of the API,
- Precise q.s. for excipient.
2 sets of specifications are possible: at release and at the end of shelf-life(list non exhaustive)
Blisters and strips should include, as a minimum, the following information