Standard Operating Procedure for In-Process Quality Testing During Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/035/2025 |
| Supersedes | SOP/GM/035/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting in-process testing during gel manufacturing to ensure that the product conforms to specified quality standards at various production stages.
2. Scope
This SOP applies to all gel batches manufactured in
the Gel Manufacturing Department and includes procedures for sampling, testing, documentation, and deviation management of in-process controls.
3. Responsibilities
- Production Chemist: To collect samples and perform preliminary checks as per BMR.
- Quality Control Analyst: To conduct detailed in-process testing of critical parameters.
- Quality Assurance Officer: To verify results and authorize continuation of manufacturing.
4. Accountability
The Head – Manufacturing is accountable for ensuring implementation and compliance with this SOP.
5. Procedure
5.1 Sampling Plan
- Follow the predefined sampling points outlined in the Batch Manufacturing Record (BMR).
- Samples shall be drawn using sanitized sampling devices under laminar airflow conditions.
- Label the sample containers with product name, batch number, sampling time, stage, and initials.
5.2 Testing Parameters
The following parameters shall be tested during various manufacturing stages:
- Appearance: Uniformity, absence of lumps or phase separation.
- pH: Measured using a calibrated digital pH meter (acceptable range defined in BMR).
- Viscosity: Checked using Brookfield viscometer at specified RPM and temperature.
- Homogeneity: Visually inspected and verified using sampling from multiple vessel locations.
- Weight per mL: Conducted for volume consistency.
- Temperature: To ensure conditions remain within process-defined range.
5.3 Frequency of In-Process Testing
- At pre-mixing stage.
- Immediately after phase mixing.
- Post pH adjustment.
- After homogenization.
- Immediately before filling.
5.4 Documentation of Results
- Record all in-process testing results in Annexure-1 (In-Process Control Log).
- Deviations must be escalated to QA immediately and documented in Annexure-2 (Deviation Log).
- Continue to next stage only upon QA approval based on results.
5.5 Acceptance Criteria
Each test result must comply with predefined specifications in the BMR. In case of out-of-specification (OOS) results:
- Pause production immediately.
- Initiate investigation as per deviation handling SOP.
- Document corrective action and retesting procedure.
6. Abbreviations
- QA: Quality Assurance
- QC: Quality Control
- BMR: Batch Manufacturing Record
- SOP: Standard Operating Procedure
7. Documents
- In-Process Control Log – Annexure-1
- Deviation Log – Annexure-2
- Batch Manufacturing Record (BMR)
8. References
- Schedule M – Good Manufacturing Practices
- Internal SOP on Handling Deviations
- USP Monographs – pH and Viscosity Testing Methods
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: In-Process Control Log
Document stage-wise test results with parameters, limits, values, time, and initials.
Annexure-2: Deviation Log
Capture deviations from standard limits, corrective actions, and QA remarks.
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/05/2022 | 1.0 | Initial SOP release | GMP compliance | QA Head |
| 02/06/2025 | 2.0 | Expanded scope to include visual and homogeneity tests | Process update | QA Head |