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

1. 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).
2. 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

1. 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).
2. 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

1. 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).
2. 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

1. 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

1. Annual Training Calendar (Annexure-1)
2. Training Needs Assessment Log (Annexure-2)
3. Training Materials Log (Annexure-3)
4. Training Attendance Log (Annexure-4)
5. Post-Training Assessment Log (Annexure-5)
6. Training Effectiveness Review Log (Annexure-6)
7. 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