Standard Operating Procedure (SOP)
Title: Analyst Qualification and Certification
SOP No.: [Insert Number]
Effective Date: [Insert Date]
Review Date: [Insert Date]
Version: [Insert Version]
1. Purpose
To establish a standardized procedure for the qualification, evaluation, and certification of
analysts performing laboratory activities to ensure accuracy, reliability, and compliance
with regulatory requirements.
2. Scope
This SOP applies to all analysts working in the Quality Control (QC), Research &
Development (R&D), and other laboratories within [Company/Organization Name].
3. Responsibilities
- Quality Assurance (QA): Approves qualification protocols, assessment tools, and
certification records; Ensures compliance with regulatory guidelines.
- Department Head / Lab Manager: Identifies training needs for analysts; Authorizes analyst
qualification and certification.
- Trainer / Qualified Senior Analyst: Conducts training and evaluation; Provides feedback
and retraining as required.
- Analyst: Completes training modules and practical assessments; Adheres to SOPs, Good
Laboratory Practices (GLP), and regulatory standards.
4. Definitions
- Analyst Qualification: Process of training and evaluating an analyst to verify competency in
laboratory methods, instruments, and documentation.
- Certification: Formal authorization granted to an analyst upon successful completion of
qualification.
- Re-qualification: Periodic or corrective re-assessment to ensure continued competency.
5. Procedure
5.1 Pre-Qualification Requirements
- Required educational background.
- Completion of GMP/GLP, safety, and data integrity training.
5.2 Training Program
- SOPs and regulatory requirements.
- Instrument operation and calibration.
- Method-specific training.
- Documentation practices.
- Safety protocols.
5.3 Qualification Process
Step 1: Shadowing a qualified analyst.
Step 2: Performing tests under supervision.
Step 3: Performing independent analysis on pre-approved samples.
Step 4: Review by evaluator.
5.4 Evaluation Criteria
- Accuracy and reproducibility.
- SOP compliance.
- Instrument handling.
- Documentation and data integrity.
- Safety adherence.
5.5 Certification
- Granted after successful completion.
- Certificate of Qualification issued.
- Authorization to perform analyses independently.
5.6 Re-Qualification
- Every [2 years] or after absence, method changes, or updates.
- Includes refresher training and reassessment.
5.7 Documentation
- Training Records.
- Qualification Protocol and Report.
- Analyst Certification Form.
- Re-qualification records.
6. References
- ICH Q7, Q10 Guidelines
- WHO Good Laboratory Practice Guidelines
- 21 CFR Part 211 (GMP for Finished Pharmaceuticals)
- Company Quality Manual
7. Annexures / Attachments
- Annexure 1: Analyst Training Checklist
- Annexure 2: Qualification Assessment Form
- Annexure 3: Analyst Certification Template
- Annexure 4: Re-qualification Log
