API manufacturing facility.

3. Responsibilities

• Production Operators: Perform tray loading, labeling, and recording activities as per instructions.
• Production Supervisor: Verify tray arrangement, check cleanliness, and approve loading.
• QA Department: Ensure compliance with SOP and good documentation practices during batch review.

4. Accountability

The Production Head is accountable for ensuring safe and GMP-compliant tray loading operations. QA is responsible for reviewing and releasing the loaded trays for drying.

5. Procedure

5.1 Pre-Loading Checks

1. Ensure line clearance for drying area is completed and documented.
2. Check availability of clean, dry trays (SS316 preferred) and verify “Cleaned” status label.
3. Ensure all trays are numbered and visually inspected for damage or residue.
4. Calibrate weighing balance used for material loading, if required.

5.2 Tray Loading Steps

1. Transfer wet cake or intermediate material to the drying area using covered containers.
2. Place trays on trolleys or work surfaces inside LAF (if applicable) to minimize contamination.
3. Use spatulas or scrapers made of SS316 to spread material uniformly across the tray surface (thickness not more than 2 cm unless specified).
4. Ensure:
   • Each tray holds approximately equal weight for uniform drying
   • No material sticks to tray edges or overlaps between trays
5. Document tray-wise weight in “Tray Loading Log” (Annexure-1).

5.3 Labeling and Transfer

1. Label each tray with:
   • Batch No.
   • Material Name
   • Tray No.
   • Net Weight
   • Date and Operator Initials
2. Arrange trays on drying trolley or in dryer as per validated loading pattern (e.g., staggered arrangement to facilitate air flow).
3. Transfer the loaded trays to the drying equipment and document dryer loading start time in the BMR.

5.4 Post-Loading Activities

1. Clean all tools and surfaces after loading and update the area cleaning record.
2. Maintain batch segregation by ensuring no trays from other batches are placed together in the dryer.
3. After drying, verify completeness of “Tray Loading Log” and ensure batch traceability.

6. Abbreviations

• SOP: Standard Operating Procedure
• SS316: Stainless Steel 316 Grade
• GMP: Good Manufacturing Practices
• BMR: Batch Manufacturing Record

7. Documents

1. Tray Loading Log (Annexure-1)
2. Batch Manufacturing Record
3. Drying Equipment Logbook

8. References

• ICH Q7 – GMP Guide for Active Pharmaceutical Ingredients
• Internal Drying Protocols and Validation Reports
• WHO TRS 1019 – Annex 2 (Good practices for pharmaceutical quality control laboratories)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Tray Loading Log

Date	Batch No.	Tray No.	Net Weight (g)	Loaded By	Checked By
13/04/2025	API-20250413	TR-001	500

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	Standardization	QA Head
13/04/2025	2.0	Included Thickness and Uniform Loading Guidelines	Process Improvement	QA Head