Mentor's Blog
Practical insights on pharmaceutical compliance, cold chain management, and the regulatory landscape. Written by Ari Nerwich.
What Counts as Summer? Seasonal Extremes in South African Temperature Mapping
Every warehouse mapping has to capture seasonal extremes, yet no guideline says which months those are. Why temperature is a critical parameter, the four reasons to map, and what 35 years of free climate data suggests about when to run a seven-day study in your region.
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No Action Required: The Most Expensive Answer in Qualification
When does equipment need qualifying, and when does a change or a periodic review mean requalifying? A practical walk through the decision, from GxP impact to scoped requalification, grounded in the WHO technical supplements on qualification and temperature mapping.
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Your Shipper Was Qualified in 2019. The Guidance Has Moved Since.
Between 2018 and 2026 the ISTA Pharma Committee published four best practice guidelines and a growing series of whitepapers on thermal shipping systems. What has changed, from defensible temperature profiles to performance verification, thermal modelling and reusable monitoring devices.
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Design It Like You'll Have to Map It
Most temperature problems in a warehouse or cold room are designed in long before the first mapping study. A practical look at the design decisions that shape temperature distribution, grounded in WHO model guidance for storage facilities and its technical supplements.
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Twenty-Five Years and Two Address Changes Later: What PIC/S Actually Rewrote
PIC/S PI 006-4 enters into force on 1 October 2026, eleven years after the Annex 15 revision it interprets. What actually changed, what it means for transport verification and thermal mapping, and why the replacement Annex 15 is already out for consultation.
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Next Customer Please: Ice Cream or Drugs?
How does the ice cream supply chain compare to pharmaceutical cold chain logistics? A surprisingly insightful look at regulation, temperature control, and why both industries face similar challenges.
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Who Graffiti'ed on My Medicine?
SAHPRA and the SAPC — who are they, what do they do, and how do they protect South African patients? Understanding the regulatory landscape starts here.
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