Standard Operating Procedure for Inline Sampling during Cream Manufacturing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/047/2025 |
| Supersedes | SOP/CRM/047/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 18/10/2025 |
| Effective Date | 23/10/2025 |
| Review Date | 18/10/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the process for inline sampling during cream manufacturing. Inline sampling is a critical process for monitoring the quality of the cream during production and ensuring that the final product meets the required specifications for consistency, texture, and other quality attributes. This SOP ensures that the sampling process is carried out systematically, minimizing contamination and ensuring that representative samples are collected at appropriate stages.
2. Scope
This SOP applies to the inline sampling of cream formulations during the manufacturing process in the Creams Department. It covers the procedures for collecting samples at different stages of production, from emulsification through homogenization, and before packaging.
3. Responsibilities
- Formulation Development Team: Responsible for determining the critical points during manufacturing where inline sampling is necessary, and defining the sampling frequency and volume required.
- Quality Control (QC): Responsible for monitoring the inline sampling process to ensure that the samples are representative and properly analyzed for compliance with the formulation specifications.
- Quality Assurance (QA): Ensures that the inline sampling procedure is followed as outlined in this SOP and that the collected samples are correctly documented and analyzed.
- Production Team: Responsible for carrying out inline sampling according to the SOP, ensuring that the samples are collected at the specified stages and volumes, and properly handled to avoid contamination.
4. Accountability
The Head of Creams Manufacturing is responsible for overseeing the inline sampling process and ensuring that it is carried out according to this SOP. The QA Manager is accountable for verifying that the samples meet quality control standards and that the entire process complies with regulatory requirements.
5. Procedure
5.1 Identification of Sampling Points
-
Identify critical points in the manufacturing process where inline sampling is necessary. These points may include:
- After emulsification to ensure uniformity and stability of the emulsion base.
- After homogenization to confirm the consistency of the cream texture and particle size distribution.
- Before final packaging to verify that the final cream product meets all specifications for viscosity, pH, and other quality attributes.
- Sampling points should be selected based on the formulation requirements and the known critical process parameters for the specific cream being produced.
5.2 Preparation for Inline Sampling
- Ensure that the necessary sampling equipment, such as sterile containers, pipettes, or sample collection devices, are ready and properly sanitized before starting the sampling process.
- Prepare the area around the sampling point to minimize contamination risks. Ensure that the equipment and the operator’s hands are clean and that contamination control measures are in place.
- If required, verify the calibration of any inline sampling devices used to collect samples.
5.3 Inline Sampling Procedure
- At the identified sampling point, initiate the sampling process. If using a valve or automated sampling system, open the system to allow the required volume of cream to be collected.
- If manual sampling is required, open the sampling valve or system and collect the sample directly from the stream. Ensure that the sample is representative of the bulk cream by allowing the flow to stabilize before collecting the sample.
- Collect the required volume of the sample, ensuring that the sample size is consistent with the specifications outlined in the MFR (typically 100-200 mL).
- After collection, immediately seal the sample container to prevent contamination or evaporation. Label the container with the batch number, time of collection, and sampling point.
5.4 Sample Handling and Transport
- Ensure that the sample is transferred to the quality control laboratory as soon as possible for analysis. If necessary, refrigerate the sample during transport to maintain its integrity.
- Document the sample’s collection details in the batch record, including the sampling time, volume, and sampling point.
5.5 Analysis of Samples
-
Once the sample has been received in the QC laboratory, carry out the following tests, as applicable:
- Viscosity: Measure the cream’s consistency to ensure it is within the required range.
- pH: Test the pH to confirm that it falls within the acceptable range (typically between 4.5 and 6.5).
- Microbial Testing: Conduct tests to check for the presence of harmful microorganisms.
- Particle Size: If required, measure the particle size to ensure the emulsion is uniform.
- Record all test results and document any deviations from the specification in the batch record. If any sample fails to meet the required specifications, initiate corrective actions and document the outcomes.
5.6 Documentation and Reporting
- Ensure that all inline sampling activities are documented, including the sample collection time, batch number, sampling points, volume, and any deviations or issues encountered during the process.
- The results from the quality control analysis of the samples must also be documented, and the findings must be reviewed and approved by the QA team before proceeding with production or packaging.
- Complete the batch record and submit it for final review and approval by the QA Manager.
5.7 Final Approval and Use of Cream
- Once all inline samples have been analyzed and meet the required specifications, the cream is approved for further processing or packaging.
- Ensure that all documentation related to inline sampling and testing is properly filed and retained for future reference and regulatory compliance.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- API: Active Pharmaceutical Ingredient
- MFR: Master Formula Record
7. Documents
- Inline Sampling Log (Annexure-1)
- Batch Record (Annexure-2)
- Quality Control Test Report (Annexure-3)
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- FDA Guidelines for Cosmetics Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Inline Sampling Log
| Batch Number | Sampling Point | Time of Collection | Volume Collected | Remarks |
|---|---|---|---|---|
| 12345 | Emulsification | 08:30 AM | 200 mL | No issues |
| 12345 | Homogenization | 09:00 AM | 200 mL | No issues |
Annexure-2: Batch Record
| Batch Number | Process Step | Time | Operator |
|---|---|---|---|
| 12345 | Inline Sampling | 08:30 AM | John Doe |
Annexure-3: Quality Control Test Report
| Test Parameter | Result | Specification | Remarks |
|---|---|---|---|
| Viscosity | 3200 cP | 3000-3500 cP | Pass |
| pH | 5.8 | 4.5-6.5 | Pass |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |