6. Fifth development phase: industrial implementation and primary stability study
At this stage of development, the data previously obtained on a pilot scale means that the manufacturing process can be transposed to an industrial scale in line with Good Manufacturing Practices (GMP) recommendations.
Industrial-scale implementation is carried out in line with the established transposition strategy. At this stage, the criticality levels of the parameters (MAs and CPs) are confirmed and refined where necessary.
Batch productions of industrial size and representative of commercial production are placed in stability and studied according to the recommendations of specific ICH stability study guides under long-term...
Exclusive to subscribers. 97% yet to be discovered!
Already subscribed? Log in!
Fifth development phase: industrial implementation and primary stability study
Sixth development phase: establishing the control strategy
Article included in this offer
"Drugs and pharmaceuticals"
(
125 articles
)
Updated and enriched with articles validated by our scientific committees
A set of exclusive tools to complement the resources
Bibliography
Exclusive to subscribers. 97% yet to be discovered!
Already subscribed? Log in!
