Procedure for Filing In-Process Control Data

Department	Quality Assurance (QA)/Quality Control (QC)/Production
SOP No.	SOP/Ointment/165
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized process for recording, verifying, and filing in-process control (IPC) data in pharmaceutical manufacturing. Proper documentation ensures regulatory compliance, traceability, and product quality throughout the production process.

2. Scope

This SOP applies to all personnel involved in Quality Assurance (QA), Quality Control (QC), and Production, responsible for collecting, verifying, and maintaining IPC data.

3. Responsibilities

• Production Operator: Records IPC data in real-time.
• QC Analyst: Verifies accuracy and completeness of IPC data.
• QA Officer: Reviews and approves IPC records.
• QA Manager: Ensures proper archiving and regulatory compliance.

4. Accountability

The QA and Production Managers are accountable for ensuring that all in-process control data is documented and maintained in compliance with GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Definition of In-Process Controls (IPC)

In-process controls are checks performed during manufacturing to ensure the process remains within validated parameters. IPC data is collected at predefined stages to monitor critical quality attributes such as:

• Raw Material Verification: Ensuring correct materials are used.
• Mixing and Blending Parameters: Monitoring temperature, time, and speed.
• pH and Viscosity Measurements: Checking the consistency of semi-solid products.
• Weight and Volume Checks: Ensuring proper filling of tubes and containers.
• Microbial and Contamination Testing: Ensuring sterility in critical processes.

5.2 Collection and Recording of IPC Data

• Production operators must record IPC data **immediately** after performing checks.
• All entries must be made in **indelible ink** (for paper records) or in **validated electronic systems**.
• Each record must include:
  • Batch number and product name.
  • Time and date of measurement.
  • Measured value (e.g., weight, pH, viscosity).
  • Acceptance criteria and pass/fail status.
  • Signature of the responsible operator.

5.3 Review and Verification of IPC Data

• QC personnel must verify all IPC records for:
  • Completeness and legibility.
  • Adherence to predefined limits.
  • Accuracy of calculations.
• Any **out-of-specification (OOS)** results must be reported to QA immediately.
• QA must review and approve IPC records before batch release.

5.4 Filing and Archiving of IPC Records

• IPC data must be filed in the **Batch Manufacturing Record (BMR).**
• Paper-based IPC records must be stored in a **fireproof archive**.
• Electronic IPC data must be stored in a **validated document management system (DMS).**
• All records must be labeled with:
  • Batch Number.
  • Date of Record.
  • Document Type (IPC Data, Analytical Test, etc.).

5.5 Handling Deviations in IPC Data

• If IPC data does not meet acceptance criteria:
  • A **Deviation Report (DR)** must be initiated.
  • Root Cause Analysis (RCA) must be performed.
  • Corrective and Preventive Actions (CAPA) must be documented.
• QA must review deviation reports and approve corrective actions.

5.6 Retention Period of IPC Data

• All IPC records must be archived for **at least 5 years.**
• Electronic backups must be performed **daily.**
• Records must be retrievable for audits and regulatory inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• IPC – In-Process Control
• DMS – Document Management System
• OOS – Out of Specification
• RCA – Root Cause Analysis
• CAPA – Corrective and Preventive Action

7. Documents

• IPC Data Collection Log (Annexure-1)
• IPC Review Checklist (Annexure-2)

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Guidelines on In-Process Control
• US FDA Guidance on Documentation of Manufacturing Processes

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 Data Collection Log

Date	Batch No.	Parameter	Measured Value	Acceptance Criteria	Operator
02/02/2025	OINT-1001	pH	6.8	6.5 – 7.5	John Doe

Annexure-2: IPC Review Checklist

Parameter	Reviewed By	Compliance Status	Comments
Weight Variation	Jane Smith	Pass	Within Limits

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded IPC Review Process	Improved Documentation	QA Head