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Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community

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1Training Workshop for Evaluators from 8acceptance criteria to control them.
National Medicines Regulatory Authorities 93.7. Process Validation and
in East African Community Dar Es Salaam, Evaluation. WHO validation definition The
Tanzania Date: 10 to 14 September 2007. documented act of proving that any
Evaluation of Quality and procedure, process, equipment, material,
Interchangeability of Medicinal Products. activity, or system actually leads to the
2Evaluation of Quality and expected results.
Interchangeability of Medicinal Products. 103.7. Process Validation and
Finished Pharmaceutical Products Evaluation. What should be validated ?
Manufacturing process and in-process “Any aspect of operation, including
controls Process validation Compliance significant changes to the premises,
with GMP Presenter: Deus K. Mubangizi, facilities, equipment or processes, which
pharmacist, MSc(Pharm.) may affect the quality of the product,
deuskm@yahoo.co.uk, dmubangizi@nda.or.ug directly or indirectly, should be
Chief Inspector of Drugs, National Drug qualified and validated”.
Authority WHO expert. 113.7. Process Validation and
3Quality dossier / Section 3 Finished Evaluation. Purpose of validation Process
Pharmaceutical Product (FPP). 3.1. validation is intended to establish that
Manufacturing and marketing authorization the proposed manufacturing process is a
3.2. Pharmaceutical development 3.3. suitable one and yields consistently a
Formulation 3.4. Sites of manufacture 3.5. product of the desired quality. i.e. that
Manufacturing process 3.6. Manufacturing the process is suitable and under control.
process controls of Critical steps and 123.7. Process Validation and
intermediates 3.7. Process validation and Evaluation. Validation mandatory for
Evaluation 3.8. Specifications for processes including a critical step The
excipients 3.9. Control of the FPP 3.10. aim is to show that critical steps are
Container/closure system (s) and other under control and lead continuously to the
packaging 3.11. Stability testing. desirable quality Examples of critical
4Quality dossier / Section 3 Finished steps (list non exhaustive) mixing,
Pharmaceutical Product (FPP). 3.12. coating, granulation, emulsification,
Container labelling 3.13. Product non-standard sterilisation.
information for health professionals 3.14. 133.7. Process Validation and
Patient information and package leaflet Evaluation. 3.7. Process Validation and
3.15. Justification for any differences to Evaluation (details on first 3 production
the product in the country or countries batches) Batches batch number batch size
issuing the submitted WHO-type place and date of manufacture batch number
certificate(s). of API(s) yield batch purpose (validation,
53.4. Manufacturing sites. Name and stability, clinical trial …) Process
street address of each facility where any equipment process parameters validation
aspect of manufacture occurs including protocol. Results critical steps in
production, sterilisation, packaging and process control finished product
quality control Include any alternative specification.
manufacturers Certificate issued by the 143.7. Process Validation and
Competent DRA according to WHO Evaluation. Concurrent validation carried
Certification scheme for each site where a out during normal production on the first
major step of manufacturing is performed 3 production batches OR For
Submit a valid GMP certificate (may not well-established processes process data,
insist if inspected by WHO). in-process controls and quality controls
63.5. Manufacturing Process. Flow chart on a total of 10- 25 batches to present a
with indication of each step showing where statistically significant picture.
materials enter the process. Indication of 153.7. Process Validation and
critical steps and in-process controls Evaluation. If validation data (on
Description of manufacturing/packaging production scale batches) are not
including Scale Equipment by type (e.g. available submit validation protocol,
tumble blender) & working capacity commitment that validation report will be
Process parameters for steps, (e.g. time, submitted later for evaluation, commitment
temperature, pH) Environmental conditions, that data will be available in case of
e.g. relative humidity for hygroscopic inspection, commitment that WHO will be
FPPs., area class for sterile FPPs. informed of any significant deviation.
73.5. Manufacturing process (cont.). 163.7. Process Validation and
Proposal for reprocessing – justified with Evaluation. Validation protocol should
data. Copy of master formula. Batch include brief description of the process
manufacturing record – real batch. Sterile with summary of critical steps and
products – sterilisation steps and/or parameters to be followed during
aseptic procedures. Description of validation, specifications of the FPP at
in-process tests including plan of release, details of analytical procedures
sampling and acceptance limits). Data for and limits, sampling plan, unifromity of
3 full scale batches to support dosage units essential for FDCs, proposed
achievement of predetermined timeframe Validation report when submitted
specifications. should include results for each batch,
83.6. Manufacturing Process Controls of certificates of analysis, batch production
Critical steps and Intermediates. records, report on usual findings,
Identification of critical steps with test modifications, observations and
methods and justified acceptance criteria conclusions.
Information on quality of isolated 17THANK YOU.
intermediates, test methods and justified
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