Standard Operating Procedure for Training Record Maintenance in QA Departments

Department	Tablet
SOP No.	SOP/TAB/201/2025
Supersedes	SOP/TAB/201/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for maintaining training records for all personnel involved in the quality assurance (QA) processes within tablet manufacturing, ensuring compliance with regulatory standards and internal quality systems.

2. Scope

This SOP applies to all personnel working in the QA department, including those involved in product quality testing, regulatory compliance, audits, and other quality control functions in tablet manufacturing.

3. Responsibilities

• Quality Assurance (QA) Manager: Responsible for ensuring that all QA personnel are adequately trained and that training records are maintained in accordance with regulatory requirements and internal policies.
• Training Coordinator: Responsible for scheduling and tracking training sessions, maintaining records, and ensuring that all training materials are up to date and relevant.
• QA Personnel: Responsible for attending all mandatory training sessions and ensuring that they understand and apply the training content in their daily work.
• Human Resources (HR): Responsible for assisting in maintaining personnel training records and ensuring compliance with training retention policies.

4. Accountability

The QA Manager is accountable for ensuring that all training records are complete, accurate, and compliant with both regulatory guidelines and company policies. The Training Coordinator is responsible for maintaining the training schedule and tracking the completion of training.

5. Procedure

5.1 Training Needs Assessment

1. Assess training needs for each individual based on their role within the QA department and the regulatory requirements for their position.
2. Ensure that new employees undergo an initial training program covering general QA processes, GMP guidelines, and company policies.
3. Identify any ongoing training needs or skill gaps that need to be addressed based on job performance, regulatory changes, or process improvements.

5.2 Training Program Development

1. Develop a comprehensive training program that covers all necessary topics, including but not limited to GMP, equipment operation, testing procedures, and internal SOPs.
2. Ensure that the training materials are up to date and meet both internal standards and applicable regulatory requirements (Annexure-1).
3. Incorporate interactive elements such as quizzes, case studies, and practical demonstrations to ensure that personnel understand and can apply the training content.

5.3 Training Implementation

1. Schedule and conduct training sessions in accordance with the training calendar. Ensure that all relevant personnel are notified in advance of training dates and times.
2. Ensure that training is conducted in a suitable environment, free from distractions, and that all necessary equipment and materials are available (e.g., slides, handouts, equipment for demonstrations).
3. Provide opportunities for participants to ask questions and clarify any doubts during the training session.

5.4 Tracking and Documentation of Training

1. Document each training session, including the topics covered, the date of the session, the instructor’s name, and the names of the attendees (Annexure-2).
2. Ensure that each participant completes a training assessment, if applicable, and that they sign an attendance sheet confirming their participation in the session.
3. Maintain training records for each employee, including the training schedule, assessment results, and any corrective actions taken if the training was not successfully completed.

5.5 Training Records Maintenance

1. Store training records in a secure, organized, and easily accessible manner. Training records must be kept for a minimum of five years or in compliance with regulatory requirements (Annexure-3).
2. Ensure that training records are updated regularly to reflect any new training completed by personnel or any refresher courses taken.
3. Ensure that training records are available for review during internal audits, inspections, or regulatory audits.

5.6 Review and Evaluation of Training Effectiveness

1. Evaluate the effectiveness of training through employee performance, feedback from participants, and the results of follow-up assessments or audits.
2. Assess whether the training program has improved the quality of work, compliance with procedures, and overall operational efficiency.
3. Modify the training program if gaps or deficiencies are identified, ensuring continuous improvement.

5.7 Corrective Actions for Training Deficiencies

1. If deficiencies are identified in training or if an employee fails to meet the required competency levels, corrective actions must be implemented.
2. Re-train the employee on the necessary topics and ensure that any gaps in knowledge or skills are addressed (Annexure-4).
3. Ensure that any corrective actions are documented and tracked to completion in the CAPA log (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action
• HR: Human Resources

7. Documents

1. Training Program Materials (Annexure-1)
2. Training Attendance Log (Annexure-2)
3. Training Records (Annexure-3)
4. Corrective Action Report (Annexure-4)
5. CAPA Log (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Training Program Materials

Training Program	Topic	Trainer	Duration
GMP Training	Good Manufacturing Practices	John Doe	3 hours

Annexure-2: Training Attendance Log

Employee Name	Training Program	Date	Signature
Jane Smith	GMP Training	01/03/2026	Jane Smith

Annexure-3: Training Records

Employee Name	Training Program	Completion Date	Results
John Doe	GMP Training	01/03/2026	Passed

Annexure-4: Corrective Action Report

Action ID	Action Description	Completion Date	Responsible Person
CAPA-001	Re-trained employee on SOPs	01/04/2026	John Doe

Annexure-5: CAPA Log

CAPA ID	Action Description	Responsible Person	Completion Date
CAPA-002	Implemented new training program for quality control	Jane Smith	01/05/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated training program details	Improved training documentation	QA Head