A large variety of analytical instruments, ranging from a simple apparatus to complex computerized systems, is used in the pharmaceutical industry to acquire data that will help ensure that products meet their specifications.
There are many ways of demonstrating that an instrument is qualified and under control, and these can include qualification, calibration, validation, and maintenance. In order to ensure “fitness for purpose”, an integrated approach, based upon a risk assessment, is recommended.
Analytical Instrument Qualification (AIQ) is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data.
Analytical Instrument Qualification Process
Qualification Phases
AIQ is not a single, continuous process but instead results from interconnected activities over the lifetime of the instrument. The first activity is the generation of a user requirements specification (URS), which defines the laboratory's particular needs and technical and operational requirements that are to be met.
The subsequent qualification activities necessary to establish fitness for purpose may be grouped into four phases: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). PQ is also sometimes called user acceptance testing (UAT).
Roles and Responsibilities
Users
- Users are ultimately responsible for specifying their needs and ensuring that a selected instrument meets them, and that data quality and integrity are maintained. The user's group encompasses analysts, their supervisors, instrument specialists, and organization management.
- Users should be adequately trained in the instrument's use, and their training records should be maintained as required by the regulations.
- Users should also be responsible for qualifying their instruments, because their training and expertise in the use of instruments make them the best-qualified group to design the instrument test(s) and specification(s) necessary for a successful AIQ.
Quality Unit
- Quality personnel are responsible for ensuring that the AIQ process meets compliance requirements, that processes are being followed, and that the intended use of the instrument is supported by complete, valid, and documented data.
Manufacturers or Suppliers
- Manufacturers are responsible for designing and manufacturing the instrument, and ensuring the quality of relevant processes used in manufacturing and assembly of the instrument.
- There should be a quality or technical agreement between the user organization and manufacturers, suppliers, service agents, or consultants who supply calibration, maintenance, qualification, or validation services; the agreement should define the scope of work and the responsibilities of the two parties.
Software Validation
The software is needed to qualify the instrument, and the instrument operation is essential when validating the software. The software validation and instrument qualification can be integrated into a single activity.
One source of the validation of software is the guide GAMP: A Risk-Based Approach to Compliant GxP Computerized Systems.
Change Control
Change control applies to all elements of qualification and may follow the general qualification process. Users should assess the effects of changes to determine what, if any, requalification activities are required. If implementation of the change is needed, install the changes to the system. Consider if the change will affect the ability of the instrument to meet the user requirements or if the user requirements have changed. Evaluate which of the existing OQ and PQ tests need revision, deletion, or addition as a result of the installed change.
Analytical Instrument Qualification Documentation
Documents obtained during qualification activities should be retained in an accessible manner. Where multiple instruments of one kind exist, documents common to all instruments and documents specific to an instrument may be stored separately. During change control, additional documents may supplement those obtained during the qualification process, and both sets of documents should be retained and maintained in a suitable manner that allows for appropriate protection and access.
