Manager is responsible for reviewing the drying process parameters and ensuring compliance with regulatory standards.

5. Procedure

5.1 Pre-Drying Preparation

1. Ensure that the fluidized bed dryer or tray dryer is clean and free from contaminants from previous batches, as per the cleaning SOP.
2. Verify that the drying equipment is properly calibrated and that all sensors for temperature and humidity are working correctly.
3. Prepare the granules for drying by ensuring they have been adequately mixed and that the binder solution is uniformly distributed.
4. Check the moisture content of the granules before beginning the drying process. The initial moisture content should be within the specified range (typically 20-30% depending on the formulation).

5.2 Setting Up the Drying Equipment

1. Set the temperature and airflow rate of the drying equipment according to the process specifications for the granulation batch.
2. For fluidized bed dryers, adjust the airflow rate and temperature to ensure uniform drying and prevent overheating of the granules.
3. For tray dryers, ensure the trays are properly loaded with granules in a single layer, with adequate spacing to allow for proper air circulation.
4. Ensure that the drying environment is controlled to maintain the desired humidity levels, preventing excessive moisture loss or contamination.

5.3 Monitoring Moisture Content During Drying

1. Monitor the moisture content of the granules at regular intervals during the drying process, using a moisture analyzer or a suitable drying method (e.g., Karl Fischer titration).
2. Ensure that the moisture content does not exceed the acceptable limits, which typically range from 1% to 5% for most tablet formulations.
3. If the moisture content is above the target range, extend the drying time or increase the airflow rate to achieve the required moisture level.
4. If the moisture content is too low, decrease the drying temperature or airflow rate to avoid over-drying the granules.
5. Record all moisture content measurements in the batch record (Annexure-1), including time and process parameters.

5.4 Adjustments and Corrections

1. If moisture levels are too high, stop the process and allow the granules to continue drying under controlled conditions until the desired moisture content is achieved.
2. If the granules are over-dried and the moisture content falls below the specified range, adjust the temperature and airflow to rehydrate the granules by adding a controlled amount of binder solution.
3. Monitor the granules for any signs of cracking or disintegration that could indicate excessive drying. If any such issues are identified, adjust the drying process to reduce the temperature or airflow rate.

5.5 Final Moisture Content Check

1. Once the granules reach the target moisture content, conduct a final moisture check to verify consistency across the batch.
2. Confirm that the granules have reached the desired moisture content as per the product specifications, typically between 1% and 5% moisture content, depending on the formulation.
3. Check the granules for uniformity in size and texture. Any irregularities or moisture issues should be documented and investigated.
4. Once the desired moisture content is verified, proceed to the next stage in tablet manufacturing or store the granules in a controlled environment for future use.

5.6 Documentation and Record-Keeping

1. Document all drying process parameters, including temperature, airflow rate, moisture content, and drying time, in the batch record (Annexure-2).
2. Ensure that any adjustments made to the drying process (e.g., temperature or airflow) are recorded in the batch record along with the reasons for these changes.
3. Review the batch records for completeness and compliance with the required specifications. Ensure that records are signed off by the responsible personnel and reviewed by QA.
4. Maintain the batch records, including moisture content logs, for audit purposes and regulatory compliance.

5.7 Equipment Shutdown and Cleaning

1. After the drying process is complete, shut down the equipment following the standard operating procedure for equipment shutdown.
2. Clean the drying equipment thoroughly to prevent cross-contamination, ensuring that all moisture, product residues, and cleaning agents are removed.
3. Record the cleaning activities in the cleaning log and ensure that the equipment is ready for the next batch of granules.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-1)
2. Moisture Content Log (Annexure-2)
3. Equipment Cleaning 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	Granule Type	Moisture Content (%)	Drying Temperature (°C)	Remarks
Batch 001	Granule A	4.5%	50°C	Within specifications
Batch 002	Granule B	3.2%	48°C	Adjusted moisture level

Annexure-2: Moisture Content Log

Batch Number	Granule Type	Moisture Content (%)	Sampling Time	Remarks
Batch 001	Granule A	4.5%	12:00 PM	Within specifications
Batch 002	Granule B	3.2%	2:00 PM	Adjusted moisture content

Annexure-3: Equipment Cleaning Log

Cleaning Date	Equipment	Cleaning Type	Performed By	Remarks
01/03/2025	Fluidized Bed Dryer	Routine Cleaning	John Doe	Performed as per SOP
15/04/2025	Tray Dryer	Maintenance Cleaning	Jane Smith	No issues found

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	Optimization of Granule Drying	QA Head