Analytical Instrument Qualification
About Analytical Instruments
Analytical instruments and devices are essential for manufacturing and quality control of biopharmaceuticals. Most of these instruments link metrological and software-controlled functions. QA is responsible for assuring that their instruments are suitably qualified.
USP general chapter <1058> on Analytical Instrument Qualification (AIQ)
In 2008 the US Pharmacopeia (USP) implemented the general chapter <1058> on Analytical Instrument Qualification (AIQ) originated by the American Association of Pharmaceutical Scientists (AAPS).
This chapter was updated in 2017 to propose an integrated approach to AIQ and Computerized System Validation (CSV) together with GAMP.
The USP <1058> has become an important document since it is the only risk-based regulatory guidance regarding analytical instrument qualification (AIQ).
Risk Assessment
A risk-based approach belongs to one of the most critical GMP requirements to identify detailed analytical instrument operating parameters to be qualified. This approach also defines the instrument classification to determine the extent of qualification activities.
System Classification
Analytical instruments and devices are categorized into groups depending on their complexity and purpose. The purpose of system classification is to determine the scope of qualification.
CSV and Data Integrity
Most analytical instruments are combined with computerized systems and contribute significantly to datasets. Software must be categorized and specified, computerized systems must be specified and both must be validated. GMP-regulated laboratories require data to be accurate, complete, reliable and consistent.
Regulatory GMP requirements
The use of qualified instruments is mandatory, as it is required by regulatory authorities such as the U.S. Food & Drug Administration (FDA) or European Medicines Agency (EMA).
Qualified instruments contribute to client’s confidence that the analytical instruments used for quality control perform suitably according to their intended purpose.
Analytical instruments should be qualified, calibrated, inspected and maintained at defined intervals to ensure adequate performance. The Guideline for Qualification and Validations are stated in the EU GMP Guide Annex 15.
Summary
The URS and the risk assessment are the most important documents as they impact directly the outcome of the qualification. However, user requirements and system specifications are not necessarily defined in the same manner between supplier and laboratory. Instrument or system specification plays a key role in procurement.
The devise of a thorough URS is of utmost avail and influences the outcome of the qualification, as the URS is linked to the operational qualification (OQ). Remember that the instrument testing performed in the OQ aim to satisfy regulatory requirements..