Highly Characterized -Poorly Characterized
The introduction of pre-approval inspection requirements for NDA and ANDA approval has resulted in greater scrutiny being placed on documentation describing the development of the formulation.
Regulatory agency expectations for cleaning validation are formidable within
the confines of marketed product manufacturing (typically highly characterized products) but
placing the same requirements upon developmental drugs (typically poorly characterized)
makes cleaning validation even more difficult.
During product development, the formulation process and equipment to be utilized in production are evaluated in order to ensure a consistent process for commercial scale manufacture.
Before the final equipment selections
are made, however, a wide variety of equipment combinations may be tried, resulting in a vast
array of cleaning combinations.
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