SOP Guide for Pharma

Capsule: SOP for Maintaining Training Records for Capsule Operators – V 2.0

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Capsule: SOP for Maintaining Training Records for Capsule Operators – V 2.0

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

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.

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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.
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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.
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6. Abbreviations

7. Documents

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

8. References

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
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