Instrument & System Suitability Specification
This specification defines the Quality Unit–approved requirements for determining the suitability and readiness of instruments and analytical systems used to generate GMP-relevant test results.
Authoritative Quality Control specification defining instrument and system suitability requirements and decision authority. This document does not define equipment operation, calibration procedures, or maintenance instructions.
1. Purpose
To establish Quality Unit–approved criteria for verifying that instruments and analytical systems are suitable for use at the time data is generated, ensuring the reliability and validity of GMP-relevant analytical results.
2. Scope
This specification applies to all instruments, equipment, and analytical systems used to support GMP testing, measurement, or evaluation activities, including laboratory instruments, computerized systems, and associated measurement devices.
Applicable Business Domains include:
- Quality Control (QC)
- Quality Assurance (QA)
- Laboratory Operations
- Engineering & Facilities
- Production (PROD), where measurement systems are used
3. Ownership & Governance
- Owner: Quality Control (Quality Unit)
- Approver: Quality Control Operations (QCO)
- Change Control: Quality Management System (QMS)
- Requirement Authority: QC-REQ-IDX
- QC-REQ-IDX Reference: QC-ANL-002
Instrument and system suitability requirements defined in this specification shall not be modified outside approved QMS change control.
4. Instrument & System Suitability Requirements
| Suitability Attribute | Requirement | Applicability |
|---|---|---|
| Qualification Status | Instruments and systems shall be qualified, as applicable, and approved for GMP use prior to generating reportable results. | All GMP-relevant instruments and systems |
| Calibration & Verification | Instruments shall be calibrated or verified within defined intervals appropriate to their intended use. | Measurement and test equipment |
| Operational Readiness | Instruments and systems shall be in proper working condition and free from known defects at the time of use. | All analytical systems |
| System Suitability Checks | Where applicable, system suitability checks shall demonstrate acceptable performance prior to or during analytical use. | Methods requiring system suitability evaluation |
| Change & Incident Impact | Equipment changes, failures, or incidents shall be evaluated for impact on data reliability and suitability. | Instruments affected by changes or events |
Demonstration of instrument and system suitability may include qualification, calibration, verification, system suitability testing, or other approved mechanisms appropriate to the system and intended use.
5. Decision Logic
- Instruments and systems meeting suitability requirements are considered conforming for use.
- Data generated using instruments or systems not demonstrated to be suitable shall not be used to support GMP acceptance or release decisions.
- Questions regarding instrument or system suitability require escalation to Quality Control for assessment.
- Final determinations regarding instrument and system suitability reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Use of unqualified or out-of-calibration instruments
- Instrument malfunctions or system failures impacting data
- Missed calibration, verification, or qualification activities
- Recurring instrument or system suitability concerns
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Instrument qualification and calibration records
- System suitability test records
- Maintenance and incident reports impacting equipment
- Quality Unit assessments of instrument or system suitability