Qualification

Qualification is the process by which it is verified and documented that equipment meets established standards and requirements throughout its lifecycle.

The key elements of the facility qualification and validation program must be clearly defined and documented in a validation plan or a similar document.

Decisions regarding the scope and extent of qualification and validation should be based on a justified and documented risk assessment.

Qualification services

offers the following qualification services in accordance with GMP requirements and industry regulatory documents:

Cleanrooms

Monitoring systems

Equipment

Typically, the qualification process includes the following stages, known as the “four Qs”:

1

Design Qualification (DQ):

Documented confirmation that the proposed design of facilities, systems, and equipment complies with GMP (Good Manufacturing Practice) requirements and the user requirements (URS – User Requirements Specification).

2

Installation Qualification (IQ):

Documented confirmation that equipment and systems are installed in accordance with the approved design, manufacturer specifications, and applicable regulatory requirements. The correctness of installation, connection of utilities (power supply, water supply, ventilation, etc.), as well as the availability of the necessary documentation are verified.

3

Operational Qualification (OQ):

Documented confirmation that the installed equipment and systems operate in accordance with predefined specifications across the full range of operating parameters. At this stage, tests are carried out to verify the critical operating parameters of the equipment.

4

Performance Qualification (PQ):

Documented confirmation that equipment and systems, operating together as a single process, can consistently produce a product that meets predefined quality specifications during routine production. This stage is carried out under real production conditions using production materials.

Assessment of equipment and engineering systems compliance.

Equipment, engineering utilities, and systems must be periodically assessed to confirm their compliance with established requirements (requalification).

The specific evaluation period must be justified, and the assessment criteria defined. Any planned changes (for example, changes in engineering utilities, systems, equipment; maintenance work; relocation, etc.) that may affect product quality must be formally documented, and their impact on the validated state or control strategy must be evaluated.

One or more stages may require re-execution, and all affected critical parameters must be reconfirmed.

By following best documentation practices, we can help you adapt your approach to preparing validation and qualification documentation, as well as to carrying out all related activities