Any action to be taken when the results of monitoring at a critical control point indicate
Having the potential to impact on product quality or performance in a significant
A step at which control can be applied and is essential to prevent or eliminate a
pharmaceutical quality hazard or to reduce it to an acceptable level.
Documented evidence that the premises, supporting systems, utilities, equipment and
processes have been designed in accordance with the requirements of good
manufacturing practices (GMP).
The multidimensional combination and interaction of input variables (e.g. material
attributes) and process parameters that have been demonstrated to provide assurance
Detailed information concerning a specific facility, process or product submitted to
the medicines regulatory authority, intended for incorporation into the application
Finished pharmaceutical product (FPP)
A product that has undergone all stages of production, including packaging in its
final container and labelling. An FPP may contain one or more APIs.
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