Standard Operating Procedure for Post-Coating Drying Process Validation
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/067/2025 |
| Supersedes | SOP/TAB/067/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 15/01/2026 |
| Effective Date | 20/01/2026 |
| Review Date | 15/01/2027 |
1. Purpose
To validate the post-coating drying process, ensuring that the coated tablets are dried to the required specifications for stability and quality.
2. Scope
This SOP applies to the drying process following tablet coating. It includes validation of drying time, temperature, and uniformity to achieve the correct coating integrity.
3. Responsibilities
- Manufacturing Personnel: Responsible for operating the drying system, following the SOP, and monitoring process parameters during the drying process.
- Quality Control (QC): Ensures the post-coating drying process meets required specifications and performs sampling to verify moisture content and coating integrity.
- Quality Assurance (QA): Ensures compliance with this SOP, validates drying equipment, and approves the process parameters for the batch.
- Maintenance Personnel: Responsible for ensuring the drying equipment is maintained and calibrated according to the required standards.
4. Accountability
The Production Manager is accountable for ensuring that the drying process is validated and operated according to this SOP. The QA Manager is responsible for ensuring that the validation process is performed accurately and for approving the final process results.
5. Procedure
5.1 Pre-Drying Setup
- Ensure that the coating on the tablets is complete and has passed inspection for uniformity and appearance.
- Verify that the drying equipment is clean, calibrated, and free from previous product residues.
- Set the drying equipment to the specified temperature and airflow settings as per the batch record.
- Ensure that the tablets are placed in the drying system in a manner that allows for even exposure to air flow for optimal drying.
5.2 Drying Process
- Start the drying process, ensuring the tablets are subjected to the predetermined temperature and airflow conditions as specified in the batch record.
- Monitor the temperature and airflow throughout the drying process to maintain consistent conditions. Make adjustments as necessary to maintain stability.
- Check the tablets regularly for any signs of over-drying, such as cracking or loss of coating integrity.
- Ensure that the drying time specified in the batch record is adhered to, and ensure even drying by periodically rotating or repositioning the tablets if necessary.
5.3 Monitoring During Drying
- Monitor the tablet weight and moisture content periodically during the drying process to ensure uniform drying.
- Use a calibrated moisture analyzer to verify that the tablets reach the desired moisture content after the drying cycle.
- Perform a random sample check of the tablets to ensure there are no defects in the coating or tablet appearance after drying.
5.4 Post-Drying Inspection
- Once the drying process is complete, remove a representative sample of tablets for inspection.
- Inspect the tablets for coating consistency, absence of defects, and ensure that no tablets are over-dried or cracked.
- Conduct a final moisture content test to confirm that the tablets meet the moisture specifications outlined in the batch record.
- Ensure that all tablets are within the acceptable range for moisture content, as excess moisture can lead to instability or poor coating adhesion.
5.5 Documentation and Record-Keeping
- Document the drying process parameters, including temperature, airflow, drying time, and moisture content, in the batch record (Annexure-1).
- Record any deviations or corrective actions taken during the drying process in the deviation report (Annexure-2).
- Ensure all documentation is signed, dated, and retained in accordance with the company’s record retention policy.
5.6 Calibration and Maintenance of Drying Equipment
- Ensure that the drying equipment is regularly calibrated according to the manufacturer’s specifications.
- Perform routine maintenance and cleaning of the drying system to maintain its efficiency and avoid cross-contamination between batches.
- Document all calibration and maintenance activities in the equipment maintenance log (Annexure-3).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
- Equipment Maintenance Log (Annexure-3)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
- 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: Batch Record
| Batch Number | Drying Time | Temperature (°C) | Airflow (m³/h) | Moisture Content (%) |
|---|---|---|---|---|
| Batch 001 | 30 minutes | 45°C | 200 m³/h | 2.5% |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 12/12/2025 | Batch 002 | Over-drying of tablets | Adjusted drying time | John Doe |
Annexure-3: Equipment Maintenance Log
| Maintenance Date | Equipment | Maintenance Performed | Performed By | Comments |
|---|---|---|---|---|
| 05/12/2025 | Drying Oven | Calibration and inspection | Jane Smith | System functioning within specifications |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated Drying Parameters | Improved Moisture Control | QA Head |