Standard Operating Procedure for Training of Personnel in Tablet Manufacturing Areas

Department	Tablet
SOP No.	SOP/TAB/174/2025
Supersedes	SOP/TAB/174/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To establish a procedure for the training of personnel involved in tablet manufacturing, ensuring that all employees are competent and qualified to perform their duties in compliance with GMP and regulatory requirements.

2. Scope

This SOP applies to all personnel involved in tablet manufacturing, including production operators, quality control (QC) staff, maintenance personnel, and supervisory staff.

3. Responsibilities

• Human Resources (HR): Responsible for coordinating the training process, maintaining training records, and ensuring that training programs are compliant with regulatory requirements.
• Production Supervisor: Ensures that all personnel are adequately trained before performing their duties and monitors their performance during training.
• Quality Assurance (QA): Reviews and approves training programs to ensure they meet GMP standards and that all personnel are trained on relevant procedures and regulations.
• Department Heads: Ensures that department-specific training is provided and that employees are evaluated to confirm their competency.

4. Accountability

The Production Supervisor is accountable for ensuring that all personnel are trained and competent in their respective areas. The HR department is responsible for organizing and maintaining training records. QA ensures compliance with regulatory requirements during the training process.

5. Procedure

5.1 Training Needs Assessment

1. Identify training needs for each department involved in tablet manufacturing based on job responsibilities, regulatory requirements, and quality standards.
2. Evaluate new employees, as well as any existing employees transitioning to new roles or equipment, to determine specific training requirements.
3. Prepare a comprehensive training plan that covers all necessary topics, including equipment operation, safety procedures, GMP, quality control, and process validation.

5.2 Development of Training Program

1. Develop training materials, including manuals, presentations, and hands-on activities, ensuring that they align with company standards and regulatory guidelines.
2. The training program should cover all key aspects of tablet manufacturing, such as raw material handling, tablet compression, coating, packaging, and quality control procedures.
3. Ensure that training materials are regularly reviewed and updated to reflect any changes in equipment, processes, or regulatory requirements.

5.3 Conducting Training

1. Training should be conducted by qualified personnel, such as supervisors, trainers, or subject matter experts, who are knowledgeable in the specific areas of tablet manufacturing.
2. Provide both theoretical and practical training. Theoretical training should cover regulatory requirements, standard operating procedures (SOPs), and quality standards, while practical training should focus on hands-on experience with equipment and processes.
3. Ensure that training is interactive, and encourage employees to ask questions and engage in discussions to ensure full understanding.
4. For new employees, ensure that they receive an introduction to the facility, safety protocols, and GMP requirements before performing tasks on the production floor.

5.4 Monitoring and Evaluation

1. During and after the training, evaluate employee performance to ensure they have understood and can competently apply the training material.
2. Use written tests, practical exams, and on-the-job assessments to evaluate the effectiveness of the training program.
3. Document the results of the evaluations in the employee’s training record (Annexure-1).
4. If any deficiencies are identified, additional training or remedial actions should be taken to address the gaps in knowledge or skills.

5.5 Certification of Training

1. Upon successful completion of the training program, employees will be issued a training certificate, confirming their competence in the areas covered by the training.
2. Maintain training records, including certificates, evaluation results, and any corrective actions taken, in compliance with the company’s record retention policy.
3. The employee’s training record will be reviewed periodically to ensure continued compliance with training requirements.

5.6 Ongoing Training and Re-certification

1. Conduct ongoing training sessions, as necessary, to keep employees updated on new processes, equipment, and regulatory requirements.
2. Re-certify employees periodically based on regulatory requirements and the complexity of their roles in tablet manufacturing.
3. Ensure that retraining occurs when there are significant changes to procedures, equipment, or compliance standards.

5.7 Documentation and Record Keeping

1. Document all training activities in the training records system (Annexure-2), including the names of participants, training topics, dates, and the names of instructors.
2. Ensure that all training records are properly filed and accessible for internal audits or regulatory inspections.

6. Abbreviations

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

7. Documents

1. Training Record (Annexure-1)
2. Training Certificate (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001: Quality Management Systems
• European Pharmacopoeia (EP) – Training Requirements for Pharmaceutical Manufacturing

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

Employee Name	Training Date	Training Topic	Trainer Name	Score
John Doe	01/01/2026	Tablet Compression Process	Jane Smith	90%

Annexure-2: Training Certificate

Employee Name	Training Program	Completion Date	Certificate Number
John Doe	Tablet Compression Process	02/01/2026	TC-12345

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 process	Expanded scope to include all relevant personnel	QA Head