storage (e.g., 2-8°C or -20°C).

Light-Sensitive Materials: Must be protected from exposure to UV and visible light.

Humidity-Sensitive Materials: Must be stored in low-humidity conditions or controlled desiccators.

5.2 Preparation for Dispensing

• Verify that materials requiring special storage conditions are correctly labeled and stored.
• Ensure environmental conditions are met:
  • Refrigeration (2-8°C) for biologicals and certain APIs.
  • Freezer (-20°C or lower) for highly unstable compounds.
  • Desiccators for humidity-sensitive powders.
  • Light-proof storage for photo-sensitive materials.
• Check the **Batch Manufacturing Record (BMR)** for specific storage and handling instructions.
• Wear appropriate **personal protective equipment (PPE)**:
  • Thermal gloves for frozen materials.
  • Protective eyewear for handling volatile or reactive substances.
  • Light-blocking aprons for UV-sensitive materials.

5.3 Dispensing Process

• Retrieve materials from storage only when ready for immediate dispensing.
• Ensure that materials remain within required conditions during handling.
• Use **designated dispensing areas** for materials requiring controlled environments.
• Limit exposure time outside the designated storage conditions:
  • Temperature-sensitive materials should not remain at room temperature for more than **5 minutes**.
  • Light-sensitive materials should be handled under **dim or amber lighting**.
  • Humidity-sensitive materials should be transferred quickly to airtight containers.
• Record dispensing details in the **Special Storage Material Dispensing Log (Annexure-1).**

5.4 Handling Deviations in Storage Conditions

• If material is exposed to improper conditions:
  • Immediately document the incident in the **Deviation Log (Annexure-2).**
  • Notify the **QA and QC departments** for assessment.
  • Isolate the affected batch and determine if it can be used, reconditioned, or rejected.
• QA must **approve corrective actions** before further processing.

5.5 Post-Dispensing Activities

• Return unused materials to **correct storage conditions immediately**.
• Ensure **containers are properly sealed** before storage.
• Verify documentation before submitting records to the QA department.

5.6 Periodic Review and Audit

• QA must perform **weekly temperature and humidity checks** on stored materials.
• All deviations and corrective actions must be reviewed in **monthly quality meetings**.
• Records must be **retained for five years** for compliance audits.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Special Storage Material Dispensing Log (Annexure-1)
• Deviation Log (Annexure-2)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO Guidelines on Proper Storage and Handling
• FDA Guidance on Stability Testing of Pharmaceuticals

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Special Storage Material Dispensing Log

Date	Material Name	Batch No.	Storage Condition	Dispensed Quantity	Operator	QA Review
02/02/2025	API X	SOP/Ointment/1001	Refrigerated (2-8°C)	2.5 kg	John Doe	Approved

Annexure-2: Deviation Log

Date	Material Name	Batch No.	Deviation Type	Root Cause	Corrective Action	QA Approval
02/02/2025	API X	SOP/Ointment/1001	Storage Temperature Exceeded	Door left open	Re-evaluated Stability	Approved

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Handling Procedures	Improved Compliance	QA Head