Determining scope of qualification of facility and critical systems
Qualification is the action done to prove that any process or any equipment produces consistent results and works properly.
Equipment and environmental control
Efforts and decisions based on the purpose should be differentiated like multipurpose vs single purpose or continuous production vs batch production
Cleaning validation limits should be specified
Calibration or preventive maintenance
Appropriate schedules for calibration and maintenance should be maintained
Computer controlled equipment’s and systems
Computer hardware and software design should be selected
To know the extent of validation the following should be considered:
Based on manufacturing and engineering provisions design specifications are formed. Reviewing the design at the beginning of the project helps in reducing the deviations during installation and operational qualification protocols. To ensure that design meets the requirements firstly the facility should be defined according to the product to be manufactured.
The construction of facility mandates adherence to title 21, section 211.42 of Code of Federal Regulations of cGMPs to process human drugs & newly proposed regulatory requirements.
Issues that arise during construction should be kept in mind by contractors, owners and facility operators.
The success of a validation project requires integration of qualification and construction activities. Such integration
Critical systems
During construction qualification following critical systems should be inspected:
Documentation
To utilize the inspections and tests they should be documented according to the cGMP requirements including the following:
Inspections and tests should be conducted according to the procedures
Personnel should be trained in procedures and training should be documented
Results obtained from tests should be according to Good Documentation Practices
Based on the project requirement, construction team should have CQ coordinator and team with construction and engineering background. They need to work with the mechanical & general contractors to procure, organize and verify the documents for turn over packages as part of good engineering practices:
The construction schedule should be monitored so the necessary inspections and tests are documented.
The tests and inspections performed should support the qualification of the utility systems. They should be performed as per the specifications and any discrepancies should be documented.
The observations should be entered to construction site audit log.
Two most common utility systems are HVAC & WFI. The tests that need to be performed are following:
Tests for HVAC
Tests for WFI
Facility, equipment, critical systems
