8.2.5 Critical and non-critical parameters should be determined by means of a risk analysis for all HVAC installation components, subsystems and controls.

8.2.6 Any parameter that may affect the quality of the pharmaceutical product, or a direct impact component, should be considered a critical parameter.

8.2.7 All critical parameters should be included in the qualification process.

Note: A realistic approach to differentiating between critical and noncritical parameters is required, to avoid making the validation process unnecessarily complex.

Example:

• The humidity of the room where the product is exposed should be considered a critical parameter when a humidity-sensitive product is being manufactured. The humidity sensors and the humidity monitoring system should, therefore, be qualified. The heat transfer system, chemical drier or steam humidifier, which is producing the humidity controlled air, is further removed from the product and may not require operational qualification.

Figure 28

Qualification is a part of validation

Equip 1 Equip 2 Equip 3 Equip 4 Equip 5 Equip 6

QUALIFICATION

VALIDATION

Equip 7

System 2 System 1

Process

Equip, equipment.

80

Figure 29

System operating ranges

• A room cleanliness classification is a critical parameter and, therefore, the room air change rates and HEPA filters should be critical parameters and require qualification. Items such as the fan generating the airflow and the primary and secondary filters are non-critical parameters, and may not require operational qualification.

8.2.8 Non-critical systems and components should be subject to GEP and may not necessarily require qualification.

8.2.9 A change control procedure should be followed when changes are planned to the direct impact HVAC system, its components and controls that may affect critical parameters.

8.2.10 Acceptance criteria and limits should be defined during the design stage.

8.2.11 The manufacturer should define design conditions, normal operating ranges, operating ranges, and alert and action limits.