Standard Operating Procedure for Qualification of Regulatory Affairs Personnel
| Department | Regulatory Affairs |
| SOP No. | RA/2026/791 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 18/04/2026 |
| Effective Date | 18/04/2026 |
| Review Date | 18/04/2028 |
Purpose
This Standard Operating Procedure (SOP) establishes the systematic process for qualification of Regulatory Affairs personnel to ensure they possess the required knowledge, skills, and competencies necessary to perform their duties effectively and in compliance with applicable regulatory requirements and company policies. This SOP supports the control objective of maintaining regulatory compliance, minimizing risk of errors in submission management, and safeguarding the integrity and quality of regulatory documentation.
Scope
This SOP applies to all Regulatory Affairs personnel involved in regulatory governance, submission preparation and management, compliance monitoring, and cross-functional coordination activities within the organization. It covers qualification activities including education, training, assessment, and documentation related to personnel suitability. The SOP excludes personnel qualification outside the Regulatory Affairs department and excludes ongoing performance management processes not related to initial or refresher qualification activities.
Responsibilities
- Regulatory Affairs Manager: Oversees qualification process, approves qualification assessments, and ensures adequate resources.
- Training Coordinator: Organizes and schedules qualification training sessions and assessments.
- Subject Matter Experts (SMEs): Develop and deliver training content, conduct assessments.
- Quality Assurance (QA): Reviews qualification records for compliance during audits and ensures adherence to SOP.
- Regulatory Affairs Personnel: Participate in qualification activities, complete training and assessments as required, maintain qualification status.
Accountability
The Regulatory Affairs Manager is accountable for ensuring full implementation, compliance, periodic review, escalation of non-compliances, and effectiveness monitoring of this SOP. The manager is responsible for timely qualification of new and existing personnel and adherence to the qualification process as defined.
Procedure
The qualification of Regulatory Affairs personnel shall be conducted through a structured process comprising the following stages:
1. Preparation and Prerequisites
Review the job descriptions and competency requirements associated with the Regulatory Affairs roles to identify qualification criteria. Ensure all relevant regulatory and internal training materials are current, approved, and accessible. Confirm the availability of qualified trainers and assessors.
2. Training Delivery
Schedule and conduct training sessions covering key regulatory principles, company policies, documentation standards, submission procedures, and applicable regulatory guidelines. Training methods may include classroom sessions, e-learning modules, workshops, and on-the-job training. Attendance and participation shall be documented.
3. Assessment and Evaluation
After completion of training, personnel shall undergo assessment via written tests, practical evaluations, or interviews conducted by SMEs to verify comprehension and competency. The assessment shall be standardized, objective, and aligned with the job-specific qualification requirements. Passing criteria should be clearly defined.
4. Documentation and Record Keeping
Maintain comprehensive qualification records including training attendance sheets, assessment results, qualification status forms, and related certificates. Records must be stored securely in compliance with document control policies and be readily retrievable for audits and inspections.
5. Qualification Approval and Communication
The Regulatory Affairs Manager shall review assessment outcomes and training records to formally approve personnel qualification. Qualified personnel shall be notified and authorized to perform their assigned regulatory activities.
6. Re-qualification and Continuous Competency
Periodic re-qualification shall be conducted in accordance with regulatory changes, process updates, or at a minimum two-year interval to ensure ongoing competency. Refresher trainings and reassessments shall follow the same structured approach. Any identified gaps must be addressed promptly.
7. Handling Deviations
Any deviations or non-conformities in qualification process or outcomes shall be documented, investigated, and corrective actions implemented. Escalation and reporting to Quality Assurance shall be performed as per the deviation management SOP.
8. Closure
Upon successful qualification and approval, update personnel training records and access rights as applicable. Ensure all documentation is complete and retain records for the defined retention period.
This procedure ensures that Regulatory Affairs personnel remain competent, comply with quality and regulatory requirements, and contribute effectively to regulatory operations and compliance.
Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- SME: Subject Matter Expert
- GMP: Good Manufacturing Practice
- RA: Regulatory Affairs
- e-learning: Electronic Learning
Documents
The following documents are used during the qualification process for Regulatory Affairs personnel:
- Training Attendance Sheet – Qualification of Regulatory Affairs Personnel (Annexure-1)
- Qualification Assessment Form for Regulatory Affairs Personnel (Annexure-2)
- Qualification Approval and Status Record (Annexure-3)
References
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ICH Q10 – Pharmaceutical Quality System
- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
- EU GMP Annex 16 – Qualification and Validation
- Company Quality Manual
- Internal Document Control and Training Policies
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Training Attendance Sheet – Qualification of Regulatory Affairs Personnel
Purpose: To document attendance of Regulatory Affairs personnel in qualification training sessions.
| Session Date | Participant ID | Participant Role | Trainer | Signature |
|---|---|---|---|---|
| 15/02/2026 | RA-001 | Regulatory Affairs Specialist | SME Trainer | Present |
| 15/02/2026 | RA-002 | Regulatory Affairs Associate | SME Trainer | Present |
| 16/02/2026 | RA-003 | Regulatory Affairs Analyst | SME Trainer | Present |
Annexure-2: Qualification Assessment Form for Regulatory Affairs Personnel
Purpose: To evaluate the competency of Regulatory Affairs personnel post training.
| Participant ID | Assessment Date | Assessment Type | Score | Result | Assessor Comments |
|---|---|---|---|---|---|
| RA-001 | 20/02/2026 | Written Test | 85% | Pass | Meets competency requirements |
| RA-002 | 20/02/2026 | Practical Evaluation | 78% | Pass | Strong understanding with minor clarifications |
| RA-003 | 21/02/2026 | Interview | N/A | Pass | Demonstrates sufficient knowledge |
Annexure-3: Qualification Approval and Status Record
Purpose: To formally document approval of qualification status for Regulatory Affairs personnel.
| Participant ID | Qualification Date | Approved By | Qualification Status | Comments |
|---|---|---|---|---|
| RA-001 | 22/02/2026 | Regulatory Affairs Manager | Qualified | Eligible for regulatory submission activities |
| RA-002 | 22/02/2026 | Regulatory Affairs Manager | Qualified | Recommended for continued competency monitoring |
| RA-003 | 23/02/2026 | Regulatory Affairs Manager | Qualified | Approved for limited regulatory documentation handling |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 18/04/2026 | 1.0 | Initial issue | New SOP creation |