Standard Operating Procedure for Record Maintenance of In-Process Control (IPC) Results
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/207/2025 |
| Supersedes | SOP/ELX/207/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a systematic approach for accurate, complete, and compliant documentation of In-Process Control (IPC) test results during the manufacturing of elixirs. This ensures traceability, supports batch release, and maintains regulatory compliance.
2. Scope
This SOP applies to all IPC records generated during elixir manufacturing, including physical, chemical, and microbiological test results conducted by QC and production personnel. It includes both manual and electronic records.
3. Responsibilities
- Production Operator:
- Record basic IPC parameters in Batch Manufacturing Record (BMR).
- QC Analyst:
- Document all IPC observations and test results in the IPC Logbook and validate against specification.
- QA Officer:
- Verify IPC records for completeness and compliance.
4. Accountability
The QC Head is accountable for maintaining IPC records. The QA Head ensures review and compliance with Good Documentation Practices (GDP) and regulatory standards.
5. Procedure
5.1 Recording of IPC Results
- All IPC results must be entered:
- In the IPC Logbook (Annexure-1)
- In the relevant section of the Batch Manufacturing Record (BMR)
- In electronic systems where applicable (with audit trail)
- Ensure entries are made immediately after each test or observation.
- Each entry must include:
- Date and time of test
- Test parameter (e.g., pH, viscosity, weight per mL, API content)
- Observed result
- Specification limit
- Initials of analyst
5.2 Correction of Entries
- Do not overwrite, scratch, or erase any data.
- Strike through the incorrect entry with a single line, write the correct value next to it, and sign with date and reason.
5.3 Retention of Records
- All IPC records shall be retained for a minimum of 5 years or as per regulatory guidelines.
- Electronic data must be backed up daily and protected with access control and audit trails.
5.4 Review and Approval
- QA must review IPC results during batch record review before product release.
- Any Out-of-Specification (OOS) result must be investigated and documented as per SOP/QC/OOS/001.
5.5 Electronic System Requirements (if applicable)
- System must comply with 21 CFR Part 11 and include:
- User authentication and access rights
- Audit trails for all modifications
- Electronic signatures
6. Abbreviations
- IPC: In-Process Control
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- BMR: Batch Manufacturing Record
- GDP: Good Documentation Practices
- OOS: Out-of-Specification
7. Documents
- IPC Logbook (Annexure-1)
- Batch Manufacturing Record (BMR)
- Deviation Report (if applicable)
8. References
- WHO TRS 996 – Annex 3: GMP for Pharmaceuticals
- 21 CFR Part 211.180 – Records and Reports
- ICH Q10 – Pharmaceutical Quality System
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 Logbook
| Date | Batch No. | Test Parameter | Result | Specification | Initials | QA Verified |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-0425-025 | pH | 6.8 | 6.5–7.0 | Rajesh Kumar | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added provisions for electronic record-keeping | Data Integrity Compliance | QA Head |