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“under anticipated conditions, consistently produces a product … which meets all
predetermined requirements” considering all sources of variability. The US FDA
guidance includes the concepts of IQ and OQ into “equipment qualifica-
tion” and defines the process performance qualification (PPQ) as the step
to “confirm the process design and demonstrate that the commercial manufacturing
process performs as expected.” The Global Harmonization Task Force (GHTF)
guidance and ISO 11607-2 include under OQ to run the process based on
the established parameters resulting from process development to assure that
the process output actually meets the defined requirements under all an-
ticipated conditions of manufacturing. The objective of the PQ is to assess
the long-term capability while considering sources of potential variability
such as machine start-ups, different operators or shifts, material lot-to-lot
differences, change over procedures.

5.3.5.3 Process control and monitoring (continuous process
verification)
Process development should also specify the process variables and attributes
and acceptance criteria for continuous monitoring or scheduled testing.
Under the FDA, these measures are defined as “continuous process verification.”
All these measures along with the acceptance criteria should be included
during the PQ.
The validation activities require substantial testing and deviations and/
or failures may be observed during the various process validation exercises.
The expectation is that the validation should include root cause investiga-
tion as well as any corrective or preventive actions.

5.3.6 Packaging and device families

Validation is an essential activity, but it can be an extensive undertaking.
Significant leveraging of cost and time can be achieved if the validation is
performed for entire packaging or medical device families.
ISO 11607-1 [72] includes a key statement that is the basis for establish-
ing packaging families:
“6.1.6 When similar devices use the same packaging system, a rationale for es-
tablishing similarities and identifying the worst-case configuration shall be docu-
mented. As a minimum, the worst-case configuration shall be used to determine
compliance with this part of ISO 11607.
NOTE For example, similarity could be established by different sizes of the same product.”

ISO 11607-2:2006/Amd:2014 [2] includes a similar statement in para-
graph 5.1.5. It further states under 5.1.4, that validation may rely on data