Operational qualification - (OQ)

In this phase the process parameters should be challenged  to assure that they will result in a product that meets all defined requirements under all anticipated conditions of manufacturing, i.e., worst case testing during routine production and process control.

OQ considerations include:

o           Process control limits (time, temperature, pressure, linespeed, setup conditions, etc.)

o           Software parameters

o           Raw material specifications

o           Process operating procedures

o           Material handling requirements

o           Process change control

o           Training

o           Short term stability and capability of the process, (latitude studies or control charts)

o          Potential failure modes, action levels and worst-case conditions (Failure Mode and Effects Analysis, Fault Tree Analysis)

The use of statistically valid techniques such as screening experiments to establish key process parameters and statistically designed experiments to optimize the process can be used during this phase.  

Performance qualification - (PQ)  

In this phase the key objective is to demonstrate the process will consistently produce acceptable product under normal operating conditions.  Please note the guidance for process stability in Annexes A and B “Methods and tools for process validation”.  

PQ considerations include:

o           Actual product and process parameters and procedures established in OQ

o           Acceptability of the product

o           Assurance of process capability as established in OQ

o         Process repeatability,  long term process stability

  Challenges to the process should simulate conditions that will be encountered during actual manufacturing.  Challenges should include the range of conditions as defined by the various action levels allowed in written standard operating procedures as established in the OQ phase and repeated enough times.