maintenance personnel who perform or support operations in aseptic and sterile areas of injectable manufacturing.

3. Responsibilities

• Training Coordinator: Schedule, execute, and maintain training records.
• Department Heads: Identify training needs and ensure participation.
• QA Personnel: Verify compliance and assess effectiveness of training.
• Employees: Attend training sessions and demonstrate competence.

4. Accountability

The Head of Quality Assurance is accountable for the development, implementation, review, and compliance of the aseptic training program.

5. Procedure

5.1 Training Categories

1. Theoretical Training: Includes cGMP principles, aseptic techniques, gowning, and microbiological concepts.
2. Practical Training: Hands-on exposure to cleanroom behavior, aseptic technique simulations, and equipment operation.
3. Qualification: Personnel must pass visual, practical, and microbiological assessments before entering Grade B or A areas.

5.2 Induction Training

1. All new hires must complete induction covering:
   • Company policies
   • SOP structure and document control
   • Cleanroom behavior
   • Contamination control
2. Training must be documented in the Induction Record (Annexure-1).

5.3 Periodic Refresher Training

1. Conduct refresher training for aseptic operations every 6 months or after any major deviation.
2. Evaluate effectiveness through written exams and simulations.

5.4 Gowning Qualification

1. Personnel shall undergo qualification to enter sterile areas:
   • Must demonstrate correct gowning as per SOP.
   • Participate in media fill or qualification runs.
   • Pass microbiological monitoring with acceptable results (Annexure-2).

5.5 Visual Inspection Qualification

1. Operators performing visual inspections must:
   • Complete visual acuity test annually.
   • Pass training using certified defective and standard vials.
   • Be certified before handling production inspection.

5.6 Documentation and Records

1. All training sessions shall be recorded in the Training Attendance Log (Annexure-3).
2. Certificates or qualification records must be archived for a minimum of 5 years.

5.7 Deviation from Training Protocol

1. Any personnel failing training shall:
   • Be restricted from aseptic areas.
   • Undergo retraining and requalification.

5.8 Trainer Qualification

1. Only experienced and qualified personnel (3+ years in aseptic area) shall conduct training.
2. Trainers must themselves be qualified in all aspects of the process.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• OJT: On-the-Job Training

7. Documents

1. Induction Record – Annexure-1
2. Gowning Qualification Log – Annexure-2
3. Training Attendance Log – Annexure-3

8. References

• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• WHO TRS 961 – Training of Personnel in Sterile Areas
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Induction Training Record

Employee Name	Department	Trainer	Date	Topics Covered
Rajesh Kumar	Production	Sunita Reddy	15/06/2025	GMP, Cleanroom Conduct

Annexure-2: Gowning Qualification Log

Employee	Date	Pass/Fail	Comments
Meera Joshi	17/06/2025	Pass	Accepted bioburden limits

Annexure-3: Training Attendance Log

Date	Trainer	Topic	Attendees	Remarks
10/06/2025	Vikram Desai	Aseptic Media Fill	8	Completed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
24/06/2025	2.0	Added refresher and gowning qualification details	Annual Review	QA Head