It covers the setting, documentation, revision, and approval of IPC limits for new and existing products.

3. Responsibilities

• Process Development: Provide development data, define preliminary IPC ranges, and propose justifications.
• QA Department: Evaluate scientific rationale, historical consistency, and approve IPC limits for implementation.
• QC Department: Confirm analytical capability, detection ranges, and accuracy for each parameter.

4. Accountability

The Head – QA is accountable for final approval of IPC limits and their justification reports. Head – Production is responsible for implementing IPC ranges in shop floor documentation.

5. Procedure

5.1 IPC Parameter Identification

1. Critical IPC parameters shall be identified based on:
   • Process development reports
   • Risk assessment and FMEA
   • Regulatory requirements
   • Validation protocols

5.2 Sources for IPC Limit Justification

1. Sources of data to support IPC limit setting include:
   • Lab-scale and pilot batch development studies
   • Tech transfer and scale-up batches
   • Process capability studies
   • 3-batch process validation data
   • Stability data (if applicable)

5.3 IPC Limit Definition Format

1. Each IPC parameter must have the following documented:
   • Parameter name and unit of measurement
   • IPC stage (e.g., after reaction, before drying)
   • Proposed range or specification
   • Justification (scientific or statistical)
   • Source data reference (Annexure-1)
2. Summarize in the IPC Limit Justification Report format (Annexure-2).

5.4 Statistical Support

1. Where applicable, apply statistical tools to analyze data:
   • Mean ± 3 standard deviation (SD)
   • Process capability indices (Cp, Cpk)
   • Regression trend lines (if temporal behavior is studied)
2. Statistical analysis must be performed using validated software or Excel with QA oversight.

5.5 Review and Approval

1. QA shall review each IPC limit report for:
   • Consistency with validation data
   • Alignment with final product specification
   • Regulatory filing (if applicable)
2. Once approved, IPC limits shall be incorporated in:
   • Master Formula Record (MFR)
   • Batch Manufacturing Record (BMR)
   • IPC checklists and logbooks

5.6 Periodic Review and Revision

1. All IPC limits shall be reviewed annually or during PQR review.
2. Revisions to IPC limits must follow change control process with updated justification.

6. Abbreviations

• IPC: In-Process Control
• MFR: Master Formula Record
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• Cp/Cpk: Process Capability Indices

7. Documents

1. IPC Limit Justification Report (Annexure-2)
2. Development Report
3. Validation Report
4. Change Control Form (if applicable)

8. References

• ICH Q8 – Pharmaceutical Development
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Current Good Manufacturing Practice

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 Limit Justification Summary

Parameter	Stage	Limit	Justification Summary	Reference Document
pH	Post-reaction	6.5–7.5	Mean ± 3SD from 10 validation batches	VAL/PD/API/013

Annexure-2: IPC Limit Justification Report Format

Product Name	ABC API
Parameter	LOD (%)
Limit	Not more than 1.5%
Stage	Post Drying
Justification	Based on 3 validation batches (1.1%, 1.2%, 1.0%) and analytical variability
Reviewed By (QA)
Date

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New Product Development	QA Head
13/04/2025	2.0	Updated statistical tools and Annexures	Annual SOP Review	QA Head