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Transcript of Manuf Process
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Slide 1 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Training Workshop for Evaluatorsfrom National Medicines Regulatory
Authorities in East AfricanCommunity
Dar Es Salaam, Tanzania
Date: 10 to 14 September 2007
Evaluation of Quality and Interchangeability ofMedicinal Products
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Slide 2 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Evaluation of Quality and Interchangeability ofMedicinal Products
Finished Pharmaceutical ProductsManufacturing process and in-process controls
Process validation
Compliance with GMPPresenter: Deus K. Mubangizi, pharmacist, MSc(Pharm.)
[email protected] , [email protected]
Chief Inspector of Drugs, National Drug AuthorityWHO expert
mailto:[email protected]:[email protected]:[email protected]:[email protected] -
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Slide 3 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Quality dossier / Section 3Finished Pharmaceutical Product (FPP)
3.1. Manufacturing and marketing authorization
3.2. Pharmaceutical development
3.3. Formulation
3.4. Sites of manufacture
3.5. Manufacturing process
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 packaging3.11. Stability testing
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Slide 4 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
Quality dossier / Section 3Finished Pharmaceutical Product (FPP)
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 orcountries issuing the submitted WHO-type certificate(s)
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Slide 6 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.5. Manufacturing Process
Flow chart with indication of each step showing wherematerials enter the process. Indication of critical steps andin-process controls
Description of manufacturing/packaging including
Scale Equipment by type (e.g. tumble blender) & working capacity Process parameters for steps, (e.g. time, temperature, pH) Environmental conditions, e.g. relative humidity for hygroscopic
FPPs., area class for sterile FPPs
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Slide 7 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.5. Manufacturing process (cont.)Proposal for reprocessing justified with data.
Copy of master formula.
Batch manufacturing record real batch.
Sterile products sterilisation steps and/or asepticprocedures.
Description of in-process tests including plan of samplingand acceptance limits).
Data for 3 full scale batches to support achievement ofpredetermined specifications.
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Slide 8 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.6. Manufacturing Process Controls ofCritical steps and Intermediates
Identification of critical steps with test methods and justifiedacceptance criteria
Information on quality of isolated intermediates, testmethods and justified acceptance criteria to control them
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Slide 9 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.7. Process Validation and Evaluation
WHO validation definition
The documented act of proving that any procedure, process,equipment, material, activity, or system actually leads to the
expected results.
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Slide 10 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.7. Process Validation and Evaluation
What should be validated ?
Any aspect of operation, including significant changes to thepremises, facilities, equipment or processes, which may affect
the quality of the product, directly or indirectly, should bequalified and validated
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Slide 11 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.7. Process Validation and Evaluation
Purpose of validation
Process validation is intended to establish that the proposedmanufacturing process is a suitable one and yields
consistently a product of the desired quality.
i.e. that the process is suitable and under control
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Slide 12 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.7. Process Validation and Evaluation
Validation mandatory for processes including a critical step
The aim is to show that critical steps are under control and leadcontinuously to the desirable quality
Examples of critical steps (list non exhaustive)
mixing,
coating,
granulation,
emulsification,
non-standard sterilisation
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Slide 13 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation (details on first 3 production batches)
Batchesbatch numberbatch sizeplace and date of manufacturebatch number of API(s)yieldbatch purpose (validation, stability, clinical trial )
Processequipmentprocess parametersvalidation protocol.
Resultscritical stepsin process controlfinished product specification
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Slide 14 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.7. Process Validation and Evaluation
Concurrent validation carried out during normal productionon the first 3 production batches
OR
For well-established processesprocess data, in-process controls and quality controls on a
total of 10- 25 batches to present a statistically significantpicture
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Slide 15 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
3.7. Process Validation and EvaluationIf validation data (on production scale batches) are not available
submit
validation protocol,
commitment that validation report will be submitted later
for evaluation,
commitment that data will be available in case ofinspection,
commitment that WHO will be informed of any significantdeviation.
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Slide 17 of 19 D.K. Mubangizi, Dar Es Salaam Sept. 2007
THANK YOU
