Standard Operating Procedure for Maintaining Training Records for Capsule Operators

Department	Human Resources / Production
SOP No.	SOP/HR/224/2025
Supersedes	SOP/HR/224/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for maintaining training records for capsule operators. Proper documentation of training activities ensures compliance with GMP, regulatory standards, and the ongoing competence of operators in capsule manufacturing processes.

2. Scope

This SOP applies to all capsule operators at the facility. It covers the process of documenting training activities, including initial training, refresher training, and any additional training specific to capsule manufacturing operations.

3. Responsibilities

• Human Resources (HR) Department: Responsible for scheduling training programs, maintaining training records, and ensuring compliance with training requirements.
• Production Supervisors: Responsible for ensuring that operators receive the required training and that their performance is evaluated post-training.
• Quality Assurance (QA) Team: Responsible for reviewing training records to ensure that all training activities are documented and compliant with GMP standards.
• Operators: Responsible for attending all training sessions as scheduled and demonstrating competency in their tasks following training.

4. Accountability

The Production Manager is accountable for ensuring that operators receive the required training and that training records are maintained. The HR Manager is responsible for organizing and archiving training records, ensuring compliance with training requirements.

5. Procedure

5.1 Identifying Training Needs

Training needs for capsule operators should be identified as follows:

1. Initial Training
   1. New operators must undergo training on all relevant capsule manufacturing processes, equipment, and safety procedures before being allowed to perform any tasks.
   2. The training must include both theoretical knowledge and practical demonstrations on equipment and process handling.
2. Refresher Training
   1. Operators must undergo periodic refresher training on GMP, equipment operation, and process updates as per the training schedule.
   2. Refresher training should be done at least annually, or as needed based on any changes in processes, equipment, or regulatory requirements.
3. Specialized Training
   1. Specialized training may be required when new equipment or processes are introduced or when an operator’s performance is deemed unsatisfactory.

5.2 Scheduling Training Sessions

Once the training needs have been identified, the following steps should be followed:

1. Coordinate Training Schedules
   1. The HR team will schedule training sessions, considering the availability of trainers, training materials, and operators.
   2. Ensure that training sessions do not disrupt ongoing production schedules.
2. Notify Operators
   1. Operators must be notified in advance of scheduled training, including the objectives, location, and duration of the session.

5.3 Conducting Training

Follow these steps during the training session:

1. Prepare Training Materials
   1. Ensure that all necessary training materials, including presentations, manuals, and equipment, are prepared and available.
   2. Materials must be up to date and aligned with current GMP standards and production procedures.
2. Conduct the Training
   1. The training should be conducted by a qualified trainer with practical knowledge of capsule production processes.
   2. Training should be interactive, with demonstrations and opportunities for questions and discussions.

5.4 Documenting Training

After the training session, follow these steps to document the training:

1. Training Record
   1. Record the details of each training session, including the date, trainer’s name, topics covered, and names of participants.
   2. Document whether the operator successfully completed the training and any areas requiring further attention or follow-up training.
2. Operator Sign-off
   1. Each operator must sign the training record to confirm their attendance and understanding of the training material.
   2. If any operator misses a session, they must complete the training at the earliest opportunity.
3. Record Storage
   1. All training records must be securely stored in both physical and electronic formats, ensuring that they are accessible for audits and regulatory inspections.

5.5 Reviewing and Updating Training Records

The HR and QA teams must periodically review and update training records as follows:

1. Review Training Effectiveness
   1. Conduct periodic assessments of the operators’ skills and knowledge to verify that the training has been effective.
   2. Evaluate operator performance and retrain if necessary.
2. Update Training Records
   1. Update training records to reflect any new training completed, including refresher courses, new processes, or equipment training.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• HR: Human Resources

7. Documents

1. Annexure 1: Training Record Template
2. Annexure 2: Training Attendance Log
3. Annexure 3: Training Effectiveness Evaluation Form

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ISO 9001:2015 – Quality Management Systems

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 Record Template

Training Date	Trainer Name	Topics Covered	Operator Name	Completion Status	Signature
01/03/2025	John Doe	Capsule Filling Process	Jane Smith	Completed	Signed

Annexure 2: Training Attendance Log

Operator Name	Training Session Date	Session Topic	Trainer Name	Attendance
Jane Smith	01/03/2025	Capsule Filling Process	John Doe	Present

Annexure 3: Training Effectiveness Evaluation Form

Operator Name	Trainer Name	Training Date	Effectiveness Rating (1-5)	Comments
Jane Smith	John Doe	01/03/2025	4	Good understanding of the process

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for maintaining training records	QA Head
01/02/2025	2.0	Updated training record template and process	Revised training process for capsule operators	QA Head