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 |