Analytical Method Suitability Specification
This specification defines the Quality Unit–approved requirements for determining the suitability of analytical methods used to generate GMP-relevant test results.
Authoritative Quality Control specification defining analytical method suitability requirements and decision authority. This document does not define analytical procedures, validation protocols, or laboratory execution instructions.
1. Purpose
To establish Quality Unit–approved criteria for evaluating whether analytical methods are suitable for their intended use, ensuring that test results used in GMP decisions are scientifically sound, reliable, and appropriate.
2. Scope
This specification applies to all analytical methods used to support identity, purity, strength, quality, safety, or acceptance decisions for components, materials, in-process materials, finished products, and packaging components.
Applicable Business Domains include:
- Quality Control (QC)
- Quality Assurance (QA)
- Laboratory Operations
- Production (PROD)
- Packaging (PKG)
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-001
Analytical method suitability requirements defined in this specification shall not be modified outside approved QMS change control.
4. Analytical Method Suitability Requirements
| Suitability Attribute | Requirement | Applicability |
|---|---|---|
| Intended Use Alignment | Analytical methods shall be appropriate for the specific quality attribute and decision they support. | All GMP-relevant analytical methods |
| Scientific Validity | Methods shall be based on sound scientific principles and capable of generating meaningful results. | All analytical methods |
| Performance Characteristics | Methods shall demonstrate suitable performance characteristics (e.g., specificity, sensitivity, accuracy, precision) appropriate to their intended use. | Methods supporting acceptance or release decisions |
| Method Control Status | Methods shall be formally approved, version-controlled, and maintained under the Quality Management System. | All GMP-relevant analytical methods |
| Change Impact Consideration | Changes to methods shall be evaluated for impact on suitability prior to implementation. | Method revisions or transfers |
Demonstration of method suitability may be achieved through validation, verification, transfer, or other scientifically justified approaches approved by the Quality Unit.
5. Decision Logic
- Analytical methods meeting suitability requirements are considered conforming for use.
- Methods not demonstrated to be suitable shall not be used to support GMP acceptance or release decisions.
- Questions regarding method suitability require escalation to Quality Control for assessment.
- Final determinations regarding analytical method 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 unapproved or uncontrolled analytical methods
- Concerns regarding method performance or reliability
- Method changes impacting acceptance decisions
- Recurring or unexplained analytical anomalies
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Method validation, verification, or transfer documentation
- Approved analytical method documents and revisions
- Suitability assessments and approvals
- Deviation and investigation records related to method performance