Spiking:Spiking can be defined as the addition of unknown amount of a compound to a standard sam…
Quality Risk Management (QRM):Quality Risk Management is a systematic process for the assessment…
Process Validation:Process Validation is defined as the collection and evaluation of data, from …
Performance Qualification (PQ):Document verification that the equipment or system operates consi…
Operational Qualification (OQ):Document verification that the system or sub-system performs as i…
Installation Qualification (IQ):The performance of tests to ensure that the installations used i…
GAP Analysis:Identification of critical element of a process which are available at the SU but a…
Sending Unit (SU):The involved discipline at an organisation from where a designated product, pr…
Finished Pharmaceutical Product (FPP):FPP or Finished Pharmaceutical Product can be defined as a…
Drug Master File (DMF):DMF or Drug Master File is teh detailed information regarding a specific …
Design Qualification (DQ):Design qualification is the document evidence that the premises, suppo…
Quality control, Analytical method transferTechnology Development and Transfer of Technology- In…
Critical Control Point (CCP):Critical control point can be defined as a step at which control ca…
Corrective Action (C/A):Corrective action is any action to be taken when the result of monitorin…
Control strategy:Control strategy is a planned set of controls, derived from current product and…
Commissioning:The setting up, adjustment and testing of equipment or a system to ensure that is …
Change Control (C/C)::Change control is a formal system by which qualified representatives of ap…
Bracketing:Bracketing is an experimental design to test only the extremes of certain design fact…
Acceptance criteria:Acceptance criteria can be defined as a measurable terms under which a test …
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