Standard Operating Procedure for Periodic Training of Warehouse Staff on Storage Best Practices
| Department | Warehouse / Quality Assurance / Human Resources |
|---|---|
| SOP No. | SOP/RM/155/2025 |
| Supersedes | SOP/RM/155/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 24/03/2025 |
| Effective Date | 31/03/2025 |
| Review Date | 24/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for conducting periodic training for warehouse staff on storage best practices. The aim is to ensure that all personnel involved in the storage and handling of raw materials adhere to Good Manufacturing Practices (GMP) and maintain the quality and integrity of materials.
2. Scope
This SOP applies to all warehouse staff, including new hires, existing employees, and temporary workers involved in the storage, handling, and management of raw materials. It covers the scheduling, content, delivery, and documentation of training sessions.
3. Responsibilities
- Warehouse Manager: Ensure all warehouse staff are trained and maintain training records.
- Quality Assurance (QA): Develop training materials, conduct training sessions, and evaluate the effectiveness of training.
- Human Resources (HR): Maintain training records and coordinate with QA for training schedules.
- Warehouse Personnel: Attend all scheduled training sessions and apply best practices in daily operations.
4. Accountability
The Warehouse Manager is accountable for ensuring that all staff are trained on storage best practices. The QA Manager is responsible for developing and delivering training content, while HR maintains training documentation and compliance records.
5. Procedure
5.1 Training Schedule and Planning
- Annual Training Calendar:
- QA, in coordination with HR, will develop an annual training calendar outlining all scheduled training sessions.
- Include mandatory training sessions at least twice a year and additional sessions as needed based on audits or regulatory changes.
- Document the training schedule in the Annual Training Calendar (Annexure-1).
- Training Needs Assessment:
- Identify specific training needs based on job roles, performance reviews, and observed gaps in compliance.
- Document the assessment results in the Training Needs Assessment Log (Annexure-2).
5.2 Training Content and Delivery
- Development of Training Materials:
- QA will develop comprehensive training materials covering topics such as:
- GMP Compliance
- Material Handling and Storage Conditions
- Temperature and Humidity Control
- Pest Control and Cleanliness
- Safety Procedures in Storage Areas
- Review and update training materials annually or as needed.
- Document training materials in the Training Materials Log (Annexure-3).
- QA will develop comprehensive training materials covering topics such as:
- Training Delivery Methods:
- Conduct training sessions in-person, through workshops, or via e-learning platforms.
- Incorporate practical demonstrations and hands-on training to reinforce learning.
- Document training sessions in the Training Attendance Log (Annexure-4).
5.3 Evaluation and Effectiveness
- Post-Training Assessments:
- Conduct written or practical assessments after each training session to evaluate understanding and retention of knowledge.
- Document assessment results in the Post-Training Assessment Log (Annexure-5).
- Effectiveness Reviews:
- QA will review training effectiveness quarterly by observing on-the-job performance and compliance with SOPs.
- Document reviews in the Training Effectiveness Review Log (Annexure-6).
5.4 Documentation and Record-Keeping
- Training Records Maintenance:
- HR will maintain all training records in both electronic and physical formats for a minimum of five years.
- Ensure training records are readily accessible for internal audits and regulatory inspections.
- Document record maintenance in the Training Records Maintenance Log (Annexure-7).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- HR: Human Resources
7. Documents
- Annual Training Calendar (Annexure-1)
- Training Needs Assessment Log (Annexure-2)
- Training Materials Log (Annexure-3)
- Training Attendance Log (Annexure-4)
- Post-Training Assessment Log (Annexure-5)
- Training Effectiveness Review Log (Annexure-6)
- Training Records Maintenance Log (Annexure-7)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
- ICH Q10: Pharmaceutical Quality System
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Annual Training Calendar
| Month | Training Topic | Trainer | Scheduled Date |
|---|---|---|---|
| April | GMP Compliance in Warehouse Operations | Ravi Kumar | 05/04/2025 |
| October | Handling and Storage of Temperature-Sensitive Materials | Neha Verma | 10/10/2025 |
Annexure-2: Training Needs Assessment Log
| Date | Employee Name | Identified Training Need | Assessed By |
|---|---|---|---|
| 24/03/2025 | Amit Joshi | Temperature Monitoring Procedures | Priya Singh |
| 24/03/2025 | Priya Singh | Pest Control in Storage Areas | Ravi Kumar |
Annexure-3: Training Materials Log
| Date | Training Topic | Material Type | Prepared By |
|---|---|---|---|
| 20/03/2025 | GMP Compliance | Presentation Slides | Neha Verma |
| 20/03/2025 | Material Handling Safety | Video Tutorial | Amit Joshi |
Annexure-4: Training Attendance Log
| Date | Employee Name | Training Topic | Trainer | Signature |
|---|---|---|---|---|
| 05/04/2025 | Ravi Kumar | GMP Compliance | Neha Verma | RK |
| 05/04/2025 | Priya Singh | GMP Compliance | Neha Verma | PS |
Annexure-5: Post-Training Assessment Log
| Date | Employee Name | Assessment Score (%) | Result (Pass/Fail) | Assessed By |
|---|---|---|---|---|
| 06/04/2025 | Amit Joshi | 85% | Pass | Neha Verma |
| 06/04/2025 | Priya Singh | 78% | Pass | Ravi Kumar |
Annexure-6: Training Effectiveness Review Log
| Date | Employee Name | Observed Compliance | Reviewed By |
|---|---|---|---|
| 10/04/2025 | Ravi Kumar | Full compliance with GMP guidelines | Amit Joshi |
| 10/04/2025 | Neha Verma | Improved material handling practices | Priya Singh |
Annexure-7: Training Records Maintenance Log
| Date | Record Type | Location of Record | Maintained By |
|---|---|---|---|
| 24/03/2025 | Attendance Logs | HR Office Archive | Neha Verma |
| 24/03/2025 | Assessment Results | Electronic Database | Ravi Kumar |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Implementation | QA Head |
| 24/03/2025 | 2.0 | Added training evaluation and effectiveness review | To improve training quality and compliance | QA Head |