deviations identified at various manufacturing stages, covering parameters like pH, LOD, assay, yield, and temperature control.

3. Responsibilities

• QA Officer: Compile IPC data monthly, perform trend analysis, identify outliers or emerging trends, and generate reports.
• QC Analyst: Submit IPC data in standardized format; support analysis with raw data when required.
• Production Supervisor: Provide context for trends/deviations observed and assist in root cause analysis.

4. Accountability

The QA Head is accountable for ensuring data trending is conducted as per this SOP and that significant findings are escalated for appropriate action.

5. Procedure

5.1 IPC Data Compilation

1. QA shall collect IPC results from all batches completed during the review period (monthly/quarterly).
2. Parameters to be trended include but are not limited to:
   • pH
   • Loss on Drying (LOD)
   • Reaction Completion Time
   • Process Yield
   • Drying Temperature
3. Enter the data in the IPC Trending Template (Annexure-1) in a spreadsheet or validated software system.

5.2 Trending Methodology

1. Calculate the following for each parameter:
   • Mean
   • Standard Deviation (SD)
   • Control Limits (±3 SD)
   • Specification Limits (as per MFR/QC Specs)
2. Use line charts or control charts to visually represent data trends batch-wise.
3. Highlight any values falling outside alert or action limits.

5.3 Analysis of Deviations

1. Review all IPC-related deviations during the review period from the Deviation Register.
2. Categorize deviations as:
   • Out-of-Specification (OOS)
   • Out-of-Trend (OOT)
   • Operational Deviations
3. Summarize the deviation frequency and common root causes in the IPC Trend Report (Annexure-2).

5.4 Corrective and Preventive Action (CAPA)

1. If repetitive deviations or negative trends are observed:
   • Initiate CAPA as per the Quality System
   • Assign timeline, responsible personnel, and verification method
2. QA shall track implementation and effectiveness review of CAPA within 30 days.

5.5 Reporting and Escalation

1. QA shall issue a monthly or quarterly IPC Trending Report summarizing:
   • Summary of parameter trends
   • Deviations identified
   • CAPAs initiated
   • Recommendations (if any)
2. Share the report with Production, QC, and Management for review and follow-up.

6. Abbreviations

• IPC: In-Process Control
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• OOT: Out of Trend
• OOS: Out of Specification

7. Documents

1. IPC Trending Template (Annexure-1)
2. IPC Trend Summary Report (Annexure-2)
3. Deviation Register

8. References

• ICH Q10 – Pharmaceutical Quality System
• ICH Q9 – Quality Risk Management
• WHO TRS 986 – GMP Guidelines
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: IPC Trending Template

Batch No.	Date	Parameter	Result	Mean	Control Limits	Remarks
API-20250413	13/04/2025	pH	6.8	6.7	6.4–7.0	Within limits

Annexure-2: IPC Trend Summary Report

Month	Total Batches	Deviations	OOS	OOT	CAPA Initiated	Remarks
April 2025	12	2	0	1	Yes	OOT for LOD trend noted

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Issue	Compliance Requirement	QA Head
13/04/2025	2.0	Incorporated CAPA tracking and deviation categorization	Audit Improvement	QA Head