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Training Workshop for Evaluators from National Medicines Regulatory
Training Workshop for Evaluators from National Medicines Regulatory
Evaluation of Quality and Interchangeability of Medicinal Products
Evaluation of Quality and Interchangeability of Medicinal Products
Quality dossier / Section 3 Finished Pharmaceutical Product (FPP)
Quality dossier / Section 3 Finished Pharmaceutical Product (FPP)
Quality dossier / Section 3 Finished Pharmaceutical Product (FPP)
Quality dossier / Section 3 Finished Pharmaceutical Product (FPP)
3.4. Manufacturing sites
3.4. Manufacturing sites
3.5. Manufacturing Process
3.5. Manufacturing Process
3.5. Manufacturing process (cont
3.5. Manufacturing process (cont
3.6. Manufacturing Process Controls of Critical steps and
3.6. Manufacturing Process Controls of Critical steps and
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
3.7. Process Validation and Evaluation
THANK YOU
THANK YOU

Презентация: «Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community». Автор: . Файл: «Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community.ppt». Размер zip-архива: 148 КБ.

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

содержание презентации «Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community.ppt»
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1 Training Workshop for Evaluators from National Medicines Regulatory

Training Workshop for Evaluators from National Medicines Regulatory

Authorities in East African Community Dar Es Salaam, Tanzania Date: 10 to 14 September 2007

Evaluation of Quality and Interchangeability of Medicinal Products

2 Evaluation of Quality and Interchangeability of Medicinal Products

Evaluation of Quality and Interchangeability of Medicinal Products

Finished Pharmaceutical Products Manufacturing process and in-process controls Process validation Compliance with GMP Presenter: Deus K. Mubangizi, pharmacist, MSc(Pharm.) deuskm@yahoo.co.uk, dmubangizi@nda.or.ug Chief Inspector of Drugs, National Drug Authority WHO expert

3 Quality dossier / Section 3 Finished Pharmaceutical Product (FPP)

Quality dossier / Section 3 Finished 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 packaging 3.11. Stability testing

4 Quality dossier / Section 3 Finished Pharmaceutical Product (FPP)

Quality dossier / Section 3 Finished 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 or countries issuing the submitted WHO-type certificate(s)

5 3.4. Manufacturing sites

3.4. Manufacturing sites

Name and street address of each facility where any aspect of manufacture occurs including production, sterilisation, packaging and quality control Include any alternative manufacturers Certificate issued by the Competent DRA according to WHO Certification scheme for each site where a major step of manufacturing is performed Submit a valid GMP certificate (may not insist if inspected by WHO)

6 3.5. Manufacturing Process

3.5. Manufacturing Process

Flow chart with indication of each step showing where materials enter the process. Indication of critical steps and in-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

7 3.5. Manufacturing process (cont

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 aseptic procedures. Description of in-process tests including plan of sampling and acceptance limits). Data for 3 full scale batches to support achievement of predetermined specifications.

8 3.6. Manufacturing Process Controls of Critical steps and

3.6. Manufacturing Process Controls of Critical steps and

Intermediates

Identification of critical steps with test methods and justified acceptance criteria Information on quality of isolated intermediates, test methods and justified acceptance criteria to control them

9 3.7. Process Validation and Evaluation

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.

10 3.7. Process Validation and Evaluation

3.7. Process Validation and Evaluation

What should be validated ? “Any aspect of operation, including significant changes to the premises, facilities, equipment or processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated”

11 3.7. Process Validation and Evaluation

3.7. Process Validation and Evaluation

Purpose of validation Process validation is intended to establish that the proposed manufacturing process is a suitable one and yields consistently a product of the desired quality. i.e. that the process is suitable and under control

12 3.7. Process Validation and Evaluation

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 lead continuously to the desirable quality Examples of critical steps (list non exhaustive) mixing, coating, granulation, emulsification, non-standard sterilisation

13 3.7. Process Validation and Evaluation

3.7. Process Validation and Evaluation

3.7. Process Validation and Evaluation (details on first 3 production batches) 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

14 3.7. Process Validation and Evaluation

3.7. Process Validation and Evaluation

Concurrent validation carried out during normal production on the first 3 production batches OR For well-established processes process data, in-process controls and quality controls on a total of 10- 25 batches to present a statistically significant picture

15 3.7. Process Validation and Evaluation

3.7. Process Validation and Evaluation

If 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 of inspection, commitment that WHO will be informed of any significant deviation.

16 3.7. Process Validation and Evaluation

3.7. Process Validation and Evaluation

Validation protocol should include brief description of the process with summary of critical steps and parameters to be followed during validation, specifications of the FPP at release, details of analytical procedures and limits, sampling plan, unifromity of dosage units essential for FDCs, proposed timeframe Validation report when submitted should include results for each batch, certificates of analysis, batch production records, report on usual findings, modifications, observations and conclusions

17 THANK YOU

THANK YOU

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