SOP-021 / SOP v1.0
Storage and transport temperature
Maintaining the conditions supporting the BUD.
Procedure
- Record the allowed range from the actual monograph and BUD. Do not replace refrigeration at 2–8 °C with an undefined cool place.
- Use a checked monitoring instrument at a representative location. Document storage suitability and variation where critical to the product.
- Record actual and minimum/maximum temperatures and power interruptions. Set alarm limits and response ownership before storage.
- Select transport packaging assessed for duration, season and route. Avoid direct contact with cold packs when freezing could damage the product.
- After an excursion quarantine product and retrieve duration/extremes. Only specific evidence supports continued use; recooling does not restart BUD.
- Explain storage/transport at handover and record acknowledgement. Link refrigerators and monitoring devices to calibration records.
Stop criterion
Unknown significant temperature exposure without supporting data: quarantine pending documented decision.
Related forms
Sources and references
- NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12