sterile injectable manufacturing.

2. Scope

This SOP applies to all QA processes including batch record review, deviation management, audit findings, product release, vendor qualifications, and change control management within sterile injectable manufacturing units.

3. Responsibilities

• QA Officer: Assists in identifying potential risks and documenting them.
• QA Manager: Leads risk evaluation meetings and assigns mitigation actions.
• Functional Departments: Participate in risk evaluation and implement assigned mitigation measures.
• QA Head: Reviews and approves all risk mitigation plans and ensures effectiveness checks.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that all QA risks are identified and appropriately mitigated as per the risk assessment and control measures outlined in this SOP.

5. Procedure

5.1 Risk Identification

1. Identify potential QA risks during:
   • Deviation and change control reviews
   • Batch record evaluations
   • Audit observations
   • Out-of-trend (OOT) or OOS incidents
   • QA walkthroughs or inspections
2. Document identified risks in the Risk Register (Annexure-1).

5.2 Risk Evaluation

1. Use a qualitative or semi-quantitative method based on:
   • Severity (impact of risk)
   • Occurrence (likelihood)
   • Detection (ability to detect before impact)
2. Calculate Risk Priority Number (RPN) = Severity × Occurrence × Detection.
3. Classify RPNs as:
   • Low (RPN ≤ 40)
   • Medium (41 ≤ RPN ≤ 80)
   • High (RPN > 80)

5.3 Risk Mitigation Strategy

1. Based on the risk rating, determine appropriate mitigation actions:
   • Low Risk – Monitor and document
   • Medium Risk – Develop CAPA plan and assign timelines
   • High Risk – Immediate action and escalation to QA Head
2. Document mitigation actions in the Risk Assessment Form (Annexure-2).

5.4 Risk Control Implementation

1. Assign responsibility for each mitigation action to relevant personnel.
2. QA shall track progress using the Mitigation Tracker (Annexure-3).
3. Mitigation effectiveness is evaluated through:
   • Reduction in similar deviations or non-conformances
   • Successful audit outcomes
   • Review of batch release trends

5.5 Risk Communication and Review

1. Communicate risks and mitigation status during monthly QA review meetings.
2. Perform a quarterly risk assessment trend analysis and summarize for the QA dashboard.
3. Update the Risk Register with closure dates and effectiveness outcomes.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• RPN: Risk Priority Number
• CAPA: Corrective and Preventive Action
• OOT: Out of Trend
• OOS: Out of Specification

7. Documents

1. Risk Register – Annexure-1
2. Risk Assessment Form – Annexure-2
3. Mitigation Tracker – Annexure-3

8. References

• ICH Q9 – Quality Risk Management
• WHO TRS No. 981 Annex 2 – Risk Management Principles
• 21 CFR Part 211 – Subpart F: Production and Process Controls

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Risk Register

Risk ID	Identified Risk	RPN	Status
RISK-QA-0024	Delayed batch record review	75	Open

Annexure-2: Risk Assessment Form

Risk ID	RISK-QA-0024
Severity	5
Occurrence	5
Detection	3
RPN	75
Mitigation Plan	Review training, establish dual-review process
Owner	Sunita Reddy

Annexure-3: Mitigation Tracker

Action Item	Owner	Due Date	Status
Establish dual-review SOP	Rajesh Kumar	30/06/2025	In Progress

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial release	New SOP	Head QA
24/06/2025	2.0	Added RPN method and mitigation tracker	Annual update	Head QA