Procedure for Conducting Sampling at Intervals
| Department | Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/073 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for conducting sampling at defined intervals during ointment manufacturing to ensure batch consistency, quality, and compliance with regulatory standards.
2. Scope
This SOP applies to Quality Control (QC) and Production personnel involved in in-process sampling of ointments at various stages of manufacturing, including raw material processing, mixing, filling, and packaging.
3. Responsibilities
- Quality Control Analyst: Conducts sampling, performs tests, and records results.
- Production Operator: Provides samples at designated time intervals.
- Production Supervisor: Ensures adherence to sampling schedules and protocols.
- Quality Assurance (QA) Personnel: Reviews and approves sampling records.
4. Accountability
The QC and QA Managers are accountable for ensuring that interval sampling is performed correctly and documented according to GMP and regulatory requirements.
5. Procedure
5.1 Equipment and Materials
- Sterile sampling containers
- Sterile spatulas or pipettes
- Labeling materials (sample tags, barcode labels)
- Temperature and humidity monitoring devices (if required)
- Sampling logbook or electronic system
5.2 Sampling Frequency
- Raw Materials: Sample each batch upon receipt and before use.
- Mixing Stage: Sample at defined intervals (e.g., every 30 minutes or as per batch record).
- Filling Stage: Collect
samples every predetermined number of filled containers.
Final Product: Take final samples before batch release for QC testing.
5.3 Sampling Procedure
5.3.1 Raw Material Sampling
- Use a sterile spatula to collect a representative sample.
- Transfer sample into a clean, labeled container.
- Seal and document the sample in the Raw Material Sampling Log.
5.3.2 In-Process Sampling
- Collect the sample at pre-defined intervals during manufacturing.
- Ensure the sample is representative of the batch.
- Record observations such as texture, color, and viscosity.
- Store samples as per storage conditions defined in the batch record.
5.3.3 Finished Product Sampling
- Collect samples from different locations of the batch (beginning, middle, and end).
- Ensure that proper identification and documentation are maintained.
- Send samples for microbiological, chemical, and physical testing.
5.4 Acceptance Criteria
- Samples must be collected as per defined intervals.
- No contamination or cross-contamination should be observed.
- All samples must be labeled and stored correctly.
5.5 Documentation
- Record all sample details in the Sampling Log.
- Ensure traceability by maintaining batch-wise sample records.
- QA personnel must review and approve all documentation.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Sampling Log (Annexure-1)
- Batch Sampling Record (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- USP <1116> – Microbiological Evaluation of Cleanrooms and Other Controlled Environments
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sampling Log
| Date | Batch Number | Process Stage | Sample ID | Sampling Time | Storage Condition | Result | Verified By |
|---|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Mixing | SMP-001 | 10:00 AM | Room Temp | Pass | QA Officer |
| 01/02/2025 | OINT-101 | Filling | SMP-002 | 12:00 PM | Room Temp | Pass | QA Officer |
Annexure-2: Batch Sampling Record
| Date | Batch Number | Sampling Stage | Time Interval | Acceptance Criteria | Result | Final Status | Approved By |
|---|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Mixing | 30 min | Homogeneous | Pass | Approved | QA Head |
| 01/02/2025 | OINT-101 | Final Product | End of batch | Meets specs | Pass | Approved | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |