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Manufacturing Process and Validation: Rutendo Kuwana
Manufacturing Process and Validation: Rutendo Kuwana
Rutendo Kuwana
Pre- formulation
Formulation
Pilot manufacture
Industrial Scale
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Assessment of Interchangeable Multisource Medicines, Kenya, August 2009
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Development of manufacturing process
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Development of manufacturing process
Scale Up Data
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Manufacturing process
Information required
Flow diagram
critical steps in-process controls
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Manufacturing process (2)
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Manufacturing process
Controls of critical steps and intermediates
Critical steps
Acceptance criteria (justified)
Test methods (cross reference acceptable)
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Manufacturing Process Controls of Critical steps and
Intermediates
Manufacturing step Test Item Methods Acceptance criteria
Thickness 4.1-4.4mm
Hardness 100N<
US FDA
Established FPPs
The manufacturer has manufactured & marketed this FPP for quite some
time
Submit review of report for 10 recent consecutive batches
Manufactured within the preceding year. If less than 10 batches, may extend the period to
3 years
result/trend/statistical analysis & discussion
Rejected batches excluded - submit failure investigation
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What should be validated ?
The aim is to show that critical steps are under control and lead
continuously to the desirable quality
coating,
granulation,
emulsification,
non-standard sterilisation
Batches
batch number
batch size
place and date of manufacture
batch number of API(s)
yield
batch purpose (validation, stability, clinical trial )
Process
equipment
process parameters
validation protocol.
Results
critical steps
in process control
finished product specification
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Validation new product
Concurrent / prospective validation (2)
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Assessment of Interchangeable Multisource Medicines, Kenya, August 2009
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Validation new product
Concurrent / prospective validation (4)
Pilot batches
Used e.g. in stability and safety/efficacy studies
Size for oral solid dosage forms: the largest of 10% of production scale or
100,000 units
Productions scale
For full validation and stability studies
Scale-up / scale down after registration
Up to10-fold compared to the original batch size (minor amendment/change)
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Process Validation Data
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Development of manufacturing process
Process Validation Scheme/Protocol
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Development of manufacturing process
Process Validation Scheme/Protocol (2)
Information required
- short description of the process including critical processing steps or parameters to be monitored
- proposed timeframe
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Assessment of Interchangeable Multisource Medicines, Kenya, August 2009
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Development of manufacturing process
Process Validation Report
After validation
Certificates of analysis
Conclusions
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Other requirements