Validation
According to international regulations the goal of validation is to: “establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
The specifications for validation are determined by each manufacturing company in accordance with international guidelines.
These specifications refer to the total life cycle of an instrument: development through use and maintenance. Consequently owners/users are responsible for validating their processes to ensure that the instrument and systems operate in a manner consistent with the predefined specifications.
Qualification
Qualification is part of the validation process that verifies the functional performance of an instrument prior to its installation to ensure its ability to achieve its intended purpose.
The four steps of instrument qualification:
• Design Qualification (DQ)
• Installation Qualification (IQ).
• Operational Qualification (OP).
• Performance Qualification (PQ).
Design qualification
The DQ phase defines the functional and operational specifications of an instrument in order to meet user requirements.
This phase is a documented verification that the proposed design of the instrument is consistent with its intended purpose in accordance with Good Manufacturing Practice (GMP).
Installation Qualification
ICP ensures that your instrument is received as designed and specified by:
• Verifying that all the parts of the instrument have been installed correctly and comply with the original design
• Identifying each component and checking them against the manufacturer’s component list. We record this process accordingly
• Checking and documenting that the instrument´s working environment is suitable for the its proper functioning
Operational Qualification
Operational Qualification is the process of testing an instrument to ensure that individual and combined systems function according to operational specifications in a determined environment.
• ICP tests and documents that an instruments´ functions conform to the manufacture´s operational specifications in its determined working space
• ICP uses certified electrical simulators and standards to verify that the instrument is processing the input signals correctly
Performance Qualification
PQ is the process of testing instruments to verify that all its systems, individual and combined, meet the function criteria specified by the manufacturer on a consistent basis and to check how the result testing is recorded. The purpose of this phase is to ensure that the instrument´s specified criteria can be reached on a reliable basis over a period of time.
• ICP runs your routine analytical procedure to demonstrate that the instrument consistently performs according to the specification requirements for routine analytical use