acceptance, quarantine, or rejection based on inspection results.

Documentation and record-keeping requirements to ensure traceability and compliance.

3. Responsibilities

• Warehouse Personnel:
  • Receive and unload water-sensitive raw materials, ensuring packaging remains intact during handling.
  • Conduct visual inspections for moisture damage, container integrity, and desiccant or moisture indicator conditions.
  • Record inspection results in the Raw Material Receiving Register (Annexure-1).
  • Segregate and quarantine any materials showing signs of moisture exposure or packaging failure.
• Quality Assurance (QA) Team:
  • Establish acceptance criteria for water-sensitive materials, including packaging and moisture control requirements.
  • Review inspection results and authorize the release, quarantine, or rejection of materials.
  • Ensure compliance with GMP and regulatory standards for handling water-sensitive substances.
• Quality Control (QC) Team:
  • Perform sampling and moisture content testing to confirm material integrity when necessary.
  • Report test results to QA for final disposition decisions.
• Procurement Department:
  • Ensure suppliers comply with moisture protection requirements and transport conditions.
  • Coordinate with vendors to resolve any issues related to moisture damage or packaging failures.

4. Accountability

The Warehouse Manager is responsible for ensuring that water-sensitive raw materials are inspected according to this SOP upon receipt. The QA Manager holds the authority to approve, quarantine, or reject materials based on inspection outcomes and QC test results. All deviations from this SOP must be documented and approved by QA to maintain GMP compliance.

5. Procedure

5.1 Pre-Receipt Preparations

1. Review of Purchase Orders and Supplier Documentation
   1. Procurement provides the warehouse with the purchase order (PO) and supplier documentation specifying the moisture protection measures used during packaging and transport.
   2. Ensure that supplier documentation includes details about moisture-resistant packaging, desiccants, and humidity control measures if applicable.
2. Inspection Area Preparation
   1. Prepare a clean, dry receiving area with controlled humidity levels (<50% RH) to prevent exposure of sensitive materials to ambient moisture during inspection.
   2. Ensure the availability of inspection tools such as desiccant color indicators, hygrometers, and protective gear (gloves, anti-static handling equipment).
3. Training for Warehouse Personnel
   1. Ensure all personnel involved in the inspection process are trained in identifying signs of moisture ingress and understanding the criticality of moisture-sensitive materials.
   2. Review the handling procedures for hygroscopic and water-sensitive materials to prevent accidental exposure during inspection.

5.2 Receiving and Initial Inspection

1. Unloading and Handling
   1. Unload water-sensitive raw materials carefully using appropriate equipment to prevent damage to moisture-resistant packaging.
   2. Avoid exposing materials to humid environments or unprotected areas during transport from the delivery vehicle to the inspection area.
2. Visual Inspection of Packaging
   1. Inspect the external packaging for signs of water exposure, including:
      • Wet or discolored cardboard, shrink wrap, or labels.
      • Condensation or water droplets inside transparent packaging materials.
      • Bulging, softened, or sagging containers, which may indicate moisture ingress.
   2. Verify that moisture-proof seals, vacuum packaging, or desiccant sachets are intact and undamaged.
3. Inspection of Moisture Indicators
   1. If the packaging includes moisture indicators (e.g., silica gel with color change or humidity cards), check their current status:
      • Blue/purple silica gel indicates dryness, while pink indicates moisture exposure.
      • Humidity indicator cards showing values above specified thresholds (e.g., >30% RH) indicate possible moisture exposure.
   2. Document any signs of moisture exposure from indicators and flag for QA review.

5.3 Documentation and Segregation

1. Raw Material Receiving Register Entry
   1. Record all relevant details in the Raw Material Receiving Register (Annexure-1), including:
      • Date of receipt and supplier name.
      • Material name, batch number, and quantity.
      • Inspection findings related to moisture exposure, packaging integrity, and indicator status.
   2. Indicate any discrepancies or issues in the remarks section of the register.
2. Quarantine and Labeling
   1. Label inspected materials based on their condition:
      • “Hold” for materials with no signs of moisture exposure.
      • “Quarantine” for materials showing potential exposure, pending QA review.
      • “Rejected” for materials with visible moisture damage or failed packaging.
   2. Store materials in designated areas under controlled humidity conditions until QA makes a final decision.

5.4 QA Review and QC Testing

1. QA Review of Documentation and Inspection Results
   1. QA reviews the Raw Material Receiving Register and associated supplier documentation to assess the adequacy of packaging and transport conditions.
   2. For materials flagged as “Quarantine,” QA performs a secondary inspection to verify the presence or absence of moisture exposure.
2. QC Sampling and Moisture Content Testing
   1. If QA suspects moisture ingress, QC performs moisture content testing according to the company’s Sampling SOP (Annexure-2), using techniques such as:
      • Karl Fischer titration for precise moisture quantification.
      • Loss on drying (LOD) tests for general moisture analysis.
      • Visual or spectroscopic analysis for detecting crystallization or clumping due to water exposure.
   2. Document test results and communicate findings to QA for final disposition.

5.5 Final Disposition

1. Acceptance
   1. Materials that pass visual inspection and moisture testing are labeled “Accepted” and moved to appropriate storage under controlled conditions.
   2. Update the Raw Material Receiving Register to reflect the accepted status and ensure traceability.
2. Rejection
   1. Materials that fail inspection or testing due to moisture exposure are labeled “Rejected” and moved to the designated rejection area.
   2. Document the reason for rejection in the receiving register and initiate a non-conformance report.
3. Supplier Notification and Corrective Action
   1. Procurement contacts the supplier to report moisture-related issues and coordinates returns, replacements, or corrective actions.
   2. Document all communications with the supplier, including any updates to packaging or transport protocols to prevent future occurrences.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• LOD: Loss on Drying

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Purchase Orders (PO), Supplier Invoices, and Transport Documentation
4. Certificates of Analysis (CoAs) and Moisture Control Documentation
5. Deviation/Non-Conformance Reports (if applicable)

8. References

• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• Company-Specific Procurement, QA, and Warehouse Policies

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Receiving Register

Date	Supplier Name	Material Name	Batch Number	PO Number	Quantity	Inspection Findings	Remarks
01/02/2025	ABC Chemicals	Hygroscopic API-X	X-2025-001	PO-12345	50 kg	Packaging Intact, Desiccant Blue	Accepted
02/02/2025	XYZ Pharma	Moisture-Sensitive Excipient-Y	Y-2025-002	PO-67890	100 kg	Packaging Wet, Desiccant Pink	Quarantined, Pending QC Test

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	Hygroscopic API-X	X-2025-001	John Doe	Karl Fischer Titration	Pass	Approved for Use
03/02/2025	Moisture-Sensitive Excipient-Y	Y-2025-002	Jane Smith	Loss on Drying (LOD)	Fail	Rejected Due to Moisture Exposure

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head	All	All	Established procedures for inspecting water-sensitive raw materials.
01/02/2025	2.0	Enhanced Moisture Control Checks	Standardization of Document	QA Head	All	All	Added detailed guidelines for moisture indicator checks and corrective actions.