Published on 07/12/2025
Effective On-the-Job Qualification and Practical Assessment Framework for Validation Personnel
Introduction
Validation activities in pharmaceutical manufacturing require hands-on proficiency and deep regulatory understanding. While classroom and theoretical training form the foundation, on-the-job qualification (OJT) and practical assessment ensure that employees can apply knowledge under GMP conditions. This article provides a structured approach to implementing OJT programs aligned with regulatory guidelines from FDA, EMA, and WHO.
Regulatory Expectations for OJT
Regulatory bodies require documented evidence that employees are trained and qualified to perform validation tasks. Key references include:
- 21 CFR 211.25(a): Each person engaged in manufacturing, processing, packing, or holding of a drug product shall have the education, training, and experience to perform their assigned functions.
- EU GMP Chapter 2.9: Personnel should receive initial and continuing training, including hygiene instructions, relevant to their needs.
- WHO TRS 986 Annex 2: Validation activities must be executed by competent and qualified personnel, with documentation to support hands-on skill qualification.
These guidelines place significant emphasis on both the competence of the trainer and the traceability of the OJT process.
Components of a Validation OJT Program
An effective OJT program in validation should include the following components:
- OJT Plan and Schedule: Prepared for
Trainer Qualification and Responsibilities
Only qualified personnel should conduct OJT. Qualification criteria may include:
- Minimum 2 years hands-on experience in validation activities
- Completion of “Train-the-Trainer” program (documented)
- Approval from QA or Training Department
Trainers are responsible for:
- Ensuring training is aligned with current SOPs and protocols
- Providing live demonstrations in controlled conditions
- Evaluating the trainee’s performance objectively
- Documenting the completion and providing feedback
OJT Checklist Design
A good OJT checklist is task-specific and includes:
- Task name and description
- GMP reference (SOP number, protocol ID)
- Key steps with pass/fail or observation comments
- Trainer initials, trainee signature, date of completion
- Acceptance criteria (e.g., “Gloved swab sampling with no contact errors”)
Here’s an example for cleaning validation swab sampling:
| Step | Description | Result | Remarks |
|---|---|---|---|
| 1 | Select sampling location as per protocol | Pass | Compliant |
| 2 | Label and disinfect swab tube before entry | Pass | Used 70% IPA |
| 3 | Swab using horizontal and vertical strokes | Fail | Retest needed – improper angle |
Timing and Duration of OJT
OJT should be conducted shortly after theoretical training and before independent task execution. Recommended minimum durations:
- Cleaning validation sampling: 3 supervised sessions
- Equipment qualification data recording: 2 days with live execution
- Temperature mapping setup: 2 complete test runs
Include these durations in your training matrix and validation master plan (VMP). For template documents, refer to pharmaregulatory.in.
Competency Assessments and Final Qualification
Once OJT is completed, each trainee should undergo a competency-based assessment to validate readiness. These assessments should include:
- Hands-on task repetition under observation (e.g., executing a sampling SOP as per protocol)
- Scenario-based Q&A: Assess how the trainee would handle deviations or unexpected results
- Checklist-based scoring system: Each step scored to meet minimum acceptable percentage (e.g., 85%)
- Final approval by QA/Training Coordinator: Ensures objectivity and regulatory alignment
Records of assessments, trainer comments, and CAPAs (if any) must be retained as part of the training file. Example:
- “Operator passed practical test on protocol execution with 92% score. Minor correction noted on logbook entry format. Retraining advised in 1 month.”
Handling Deviations During OJT
Any deviations or non-conformances observed during OJT must be documented immediately. These may include:
- Incorrect gowning or entry into classified area
- Failure to follow protocol sampling steps
- Improper data recording
Deviation records should be evaluated as learning opportunities. CAPA may include retraining, revision of SOP, or enhanced supervision. Avoid using actual production materials during high-risk OJT to prevent batch failures.
Audit Readiness and Documentation Practices
OJT and practical assessment documentation is subject to regulatory review. Ensure that records include:
- OJT plan and schedule per trainee
- Signed OJT checklists with trainer/trainee/date
- Assessment results and qualification decision
- Training matrix update reflecting completion
- Version-controlled SOPs/protocols used during training
During FDA or EMA audits, be prepared to present OJT evidence for key validation personnel. Common inspector questions include:
- “Show me how this person was trained to perform swab sampling.”
- “What tasks were covered during OJT and when?”
- “Who qualified this person and under what criteria?”
Integrate OJT records into Learning Management Systems (LMS) if used. Audit trails for completion, trainer approval, and expiry of qualification must be traceable.
Requalification and Retraining Cycles
Personnel engaged in high-impact validation tasks must undergo periodic requalification. Suggested frequencies:
| Validation Task | Requalification Frequency | Trigger Events |
|---|---|---|
| Cleaning Validation Sampling | Every 12 months | Deviation, SOP revision |
| Data Logger Setup & Use | Every 18 months | Equipment change, Audit finding |
| Protocol Execution & Review | Every 24 months | GMP update, Inspection prep |
Requalification may consist of both practical repetition and retraining modules, documented under GMP guidelines.
Integrating OJT with the Validation Lifecycle
OJT should align with the stage of the validation lifecycle:
- Stage 1 (Process Design): R&D-to-validation knowledge transfer training
- Stage 2 (Process Qualification): Training on PQ protocol execution, sampling strategy
- Stage 3 (Continued Process Verification): Monitoring technique, data trending, and alarm response handling
Personnel movement from one stage to another should involve bridging OJT if tasks differ significantly.
Continuous Improvement and Feedback Loops
Collect feedback from trainees and trainers to improve the OJT system. Conduct periodic training effectiveness evaluations. KPIs may include:
- % of OJT completion vs plan
- Trainer-to-trainee ratio
- Practical test pass rate on first attempt
- No. of OJT-related deviations
Leverage digital dashboards and templates from PharmaSOP.in and StabilityStudies.in to enhance control and traceability.
Conclusion
OJT and practical assessments ensure that validation personnel are not just trained but truly competent. A robust system includes role-specific plans, qualified trainers, traceable documentation, and performance-based evaluation. Integrate with the QMS and validation master plan for a compliant, audit-ready training program.
Explore more tools and SOP templates on PharmaGMP.in and keep your training practices aligned with global standards.