Raw material should be ideally managed and well documented that enables the product longevity
For the production of the API standard and modern Laboratory should be used to enhance the capability
of the API production without any risk of cross contamination with others intermediate guidelines
should be followed in risk of any health hazard.
Documentation of the production and release of batches should be thoroughly accurate to avoid any
Final Preparation for API
Process of active chemical reaction and the diversely reaction types should have maximum flexibility to
enhance the process with the equipment available which becomes optimally stabilized during API
Final Product API
As the standard and optimal needs regarding the product need is growing it should be viable to maintain
the API production across the board from the production of first batch to the last in the form of bulk size
or small scale it should be consistent enough to meet the requirement of the organizational and the
The transparency should be available as to avoid any un-convenience and the product should have
maximum efficiency as prescribed the consumer’s needs.
The Quality assurance of the API would play a major role in maintain the consistency and the viability of
Purification and steps for API
The Purification of the API should be consumed as to avoid any micro-organism for the cross
contamination of the product this can be achieved by the sole purpose of filtration, crystallization,
centrifugal force or via the combination of them including the process of drying the impurities in the API
production are removed by this procedure it should maintain the consistency of the product during the
1. Laboratory should have the necessary equipment and should be working efficiently
2. Purification of the API that has been produced should be correctly tested
3. Final product of the API Production should have the necessary documents.