Manufacturing Process. Rutendo Kuwana Technical Officer, WHO, Geneva. Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.
Technical Officer, WHO, Geneva
Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.
WHO validation definition
The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results.
“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”
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
Validation is mandatory for processes including all critical steps
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)
place and date of manufacture
batch number of API(s)
batch purpose (validation, stability, clinical trial …)
in process control
finished product specification
If validation data (on production scale batches) are not available submit
Validation report when submitted should include results for each batch, certificates of analysis, batch production records, report on unusual findings, modifications, observations and conclusions
NB: One batch, One Report
NB:Three Batches, One Report