Standard Operating Procedure for Documentation of In-Process Control Activities
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/078/2025 |
| Supersedes | SOP/SIM/078/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To define the procedure for recording and reviewing all in-process control (IPC) activities during sterile injectable product manufacturing in compliance with current Good Manufacturing Practices (cGMP).
2. Scope
This SOP applies to all personnel involved in conducting and documenting IPC tests during batch
processing of sterile injectable products in the manufacturing department.
3. Responsibilities
- Production Officer: Ensures timely IPC sampling and proper documentation.
- Quality Control Analyst: Conducts IPC tests and records results.
- Quality Assurance Officer: Reviews IPC records and ensures compliance.
4. Accountability
Head – Quality Assurance is accountable for the implementation and periodic review of this SOP and ensuring compliance.
5. Procedure
5.1 Types of In-Process Control Activities
- Solution clarity check before filtration
- pH and osmolarity of bulk solution
- Filter integrity testing
- Filling volume verification
- Visual inspection of filled units
5.2 Documentation Requirements
- Use the approved In-Process Control Logbook (Annexure-1) or controlled batch manufacturing record (BMR) for documentation.
- Record the following details immediately after each IPC:
- Date and time of activity
- Batch number
- Test performed
- Acceptance criteria
- Observed results
- Name and signature of analyst
- Each entry must be made using indelible ink without overwriting.
5.3 Review and Approval
- QA shall review and sign IPC records before allowing the next stage of processing.
- In case of any out-of-specification or deviation in results, initiate a deviation report as per SOP.
5.4 Record Archival
- All IPC records shall be retained as part of the BMR and archived for a minimum of 5 years.
6. Abbreviations
- SOP: Standard Operating Procedure
- IPC: In-Process Control
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- QC: Quality Control
7. Documents
- In-Process Control Logbook – Annexure-1
- IPC Summary Sheet – Annexure-2
- Deviation Report Form – Annexure-3
8. References
- ICH Q10 – Pharmaceutical Quality System
- WHO Technical Report Series 961, Annex 6 – GMP Guidelines
- 21 CFR Part 211 – Current Good Manufacturing Practices
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Manufacturing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: In-Process Control Logbook
| Date | Batch No. | IPC Test | Result | Acceptable Range | Analyst Initials |
|---|---|---|---|---|---|
| 18/06/2025 | INJ-2406 | Filling Volume | 1.01 mL | 1.00 ± 0.05 mL | SK |
Annexure-2: IPC Summary Sheet
| Batch No. | Test | Result Summary | Remarks |
|---|---|---|---|
| INJ-2406 | pH | 6.8 | Within limits |
Annexure-3: Deviation Report Form
| Deviation ID | Date | Description | Root Cause | Corrective Action |
|---|---|---|---|---|
| DEV-071 | 17/06/2025 | Volume deviation during filling | Nozzle obstruction | Nozzle cleaned |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial version | New SOP | QA Head |
| 18/06/2025 | 2.0 | Updated IPC tests and annexures | Annual Review | QA Head |