Standard Operating Procedure for Training Operators in Dispensing Practices

Department	Capsule Manufacturing
SOP No.	SOP/CM/020/2025
Supersedes	SOP/CM/020/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This SOP outlines the procedure for training operators in dispensing practices to ensure that all operators understand and comply with the standards and procedures for dispensing materials in capsule manufacturing.

2. Scope

This SOP applies to all operators involved in dispensing activities, including the handling of active pharmaceutical ingredients (APIs), excipients, and other materials used in capsule manufacturing.

3. Responsibilities

• Manufacturing Personnel: Responsible for attending training sessions, understanding the dispensing procedures, and adhering to safety protocols.
• Training Coordinator: Responsible for planning, organizing, and delivering training programs to operators on dispensing practices.
• Quality Control (QC) Team: Ensures that the dispensing practices are understood and followed by the operators during production.
• Quality Assurance (QA) Team: Oversees the overall training program, ensuring that all training records are completed and up to date.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring that all operators are properly trained on dispensing practices. The QA Manager is responsible for ensuring that training programs are effective, up-to-date, and compliant with regulatory requirements.

5. Procedure

5.1 Identifying Training Needs

Ensure that training needs are identified and addressed effectively:

1. Assess Training Requirements
   1. Review the job responsibilities and qualifications of operators to identify areas where additional training is required.
   2. Identify any gaps in knowledge or skills, particularly related to the handling of materials, equipment operation, and safety practices in dispensing.
2. Consult with Department Heads
   1. Consult with the Manufacturing, QA, and QC departments to identify specific training requirements based on operational needs and regulatory standards.
   2. Incorporate input from experienced operators and managers to ensure all relevant topics are covered in the training program.

5.2 Developing the Training Program

Ensure the development of a comprehensive training program:

1. Training Curriculum
   1. Develop a curriculum that covers essential dispensing procedures, including material handling, equipment operation, safety protocols, and GMP compliance.
   2. Include hands-on training, where operators practice dispensing procedures under supervision to reinforce learning and improve competency.
2. Training Materials
   1. Prepare training materials, including SOPs, job aids, instructional videos, and other resources that can help operators understand the dispensing practices and procedures.
   2. Ensure that training materials are updated regularly to reflect any changes in procedures, equipment, or regulatory requirements.
3. Training Schedule
   1. Create a training schedule that includes the frequency of training sessions, duration of each session, and the sequence of topics to be covered.
   2. Ensure that the schedule accommodates the needs of all operators and that training does not interfere with production schedules.

5.3 Delivering the Training Program

Ensure that training is delivered effectively to all operators:

1. Instructor-Led Training
   1. Conduct instructor-led training sessions where the training coordinator or subject matter expert explains the procedures, followed by a Q&A session to clarify any doubts.
   2. Provide opportunities for operators to ask questions and engage with the trainer to ensure understanding.
2. Hands-On Practice
   1. Allow operators to practice dispensing procedures under supervision, ensuring they can perform the tasks correctly and safely before working independently.
   2. Supervise the practice sessions closely and provide feedback on any mistakes or areas for improvement.
3. Evaluation and Assessment
   1. At the end of the training session, evaluate the operators’ understanding and ability to perform dispensing procedures through written tests or practical assessments.
   2. Record the results of the assessments and provide additional training to those who require further improvement.

5.4 On-the-Job Training and Mentorship

Ensure that operators receive continuous support and mentorship:

1. Assign Mentors
   1. Assign experienced operators as mentors to guide and support new operators during their initial period in the dispensing area.
   2. Mentors should provide hands-on guidance, reinforce proper dispensing techniques, and offer advice on best practices in the dispensing process.
2. Ongoing Evaluation
   1. Monitor the performance of operators during on-the-job activities to ensure they are consistently following the correct dispensing practices.
   2. Provide feedback and additional training if necessary to address any issues or improve performance.

5.5 Evaluating Training Effectiveness

Ensure that the training program is effective and leads to improved dispensing practices:

1. Performance Monitoring
   1. Regularly monitor the performance of trained operators to assess whether the training has translated into better dispensing practices and compliance with SOPs.
   2. Track any incidents or deviations in dispensing to identify areas where additional training may be required.
2. Feedback Collection
   1. Collect feedback from operators on the training program to identify areas for improvement and ensure that it meets their needs.
   2. Use the feedback to refine future training sessions and enhance the overall training experience for operators.
3. Continuous Improvement
   1. Update and improve the training program based on feedback, performance evaluations, and any changes to procedures, equipment, or regulations.

5.6 Record-Keeping and Documentation

Ensure that all training activities are properly documented:

1. Training Records
   1. Maintain accurate records of all training sessions, including dates, topics covered, personnel trained, and training outcomes.
   2. Ensure that training records are signed by the operator, trainer, and QA personnel to confirm that the training has been completed successfully.
2. Follow-Up Actions
   1. Document any follow-up actions or additional training sessions required based on the evaluation results or operator performance.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• API: Active Pharmaceutical Ingredient

7. Documents

1. Training Records (Annexure-1)
2. Training Assessment Log (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products

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 Records

Date	Personnel Name	Training Topic	Trainer Name
02/02/2025	John Doe	Dispensing Practices and Safety	Jane Smith

Annexure-2: Training Assessment Log

Date	Personnel Name	Assessment Results	Trainer Comments
02/02/2025	John Doe	Pass	Operator demonstrated excellent understanding of dispensing procedures.

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 procedure and materials	Standardization and improvements	QA Head