Standard Operating Procedure for Documentation of In-Process Control Results in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/087/2025 |
| Supersedes | SOP/API/087/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a standard procedure for documenting all in-process control (IPC) test results generated during the manufacture of Active Pharmaceutical Ingredients (APIs), ensuring traceability, accuracy, and compliance with GMP and data integrity principles.
2. Scope
This SOP applies to the documentation of IPC tests performed by production and QC personnel throughout the manufacturing lifecycle of intermediates and
APIs, including parameters such as pH, LOD, temperature, yield, appearance, and assay.
3. Responsibilities
- Production Chemist/Operator: Record IPC results promptly in the BMR and applicable logbooks.
- QC Analyst: Review and verify the IPC results and record them in lab worksheets.
- QA Officer: Review completed documentation for correctness and compliance.
4. Accountability
Production Head is accountable for complete and accurate recording of IPC results. QA Head is responsible for reviewing and ensuring data integrity and traceability.
5. Procedure
5.1 IPC Parameters and Records
- IPC parameters shall be defined in the Master Formula Record (MFR) and include:
- Appearance
- pH
- LOD
- Conductivity
- Assay
- TLC or HPLC results
- Temperature and time records
- These shall be recorded during sampling or observation, using indelible ink (blue/black only) in the Batch Manufacturing Record (BMR).
5.2 Recording of Results
- Enter values in the respective IPC table format within the BMR at the time of observation or immediately after analysis.
- Each entry shall include:
- Result
- Date and time
- Initials of person performing the test
- Use “NA” (Not Applicable) if a test is not required; do not leave fields blank.
- Use “NR” (Not Recorded) only when a result is unavailable due to an explainable reason, and document justification.
5.3 Corrections and Deviations
- For corrections:
- Strike through the incorrect entry with a single line.
- Do not use correction fluids.
- Write the correct entry, sign, date, and provide reason for correction.
- For any result falling outside the specification:
- Stop processing immediately.
- Notify QA and initiate deviation documentation as per relevant SOP.
5.4 Archiving and Retention
- All IPC records must be attached to the BMR and stored in the QA archive room.
- Electronic records, if applicable, must comply with 21 CFR Part 11 standards.
- Retention period: Minimum of 5 years or as per regulatory/customer requirement.
6. Abbreviations
- IPC: In-Process Control
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- MFR: Master Formula Record
- QA: Quality Assurance
- QC: Quality Control
- LOD: Loss on Drying
7. Documents
- In-Process Control Results Logbook (Annexure-1)
- Batch Manufacturing Record
- Deviation Form (if applicable)
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – US FDA cGMP
- WHO TRS 986 – Good Manufacturing Practices
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: In-Process Control Results Logbook
| Date | Batch No. | Parameter | Observed Value | Limits | Performed By | Remarks |
|---|---|---|---|---|---|---|
| 13/04/2025 | API-20250413 | LOD | 0.88% | NMT 1.0% | Within limits |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | Process Control Compliance | QA Head |
| 13/04/2025 | 2.0 | Added electronic documentation provisions and NA/NR handling | Audit Recommendation | QA Head |