Pharma Manufacturing

Your product has passed stability
tests. Ensure distribution meets
the same standards.

Manufacturing QA is rigorous. Distribution cold chain often isn’t. TempAid closes that gap. ISTA-validated systems, GS1-labeled SKUs, and a documentation package built for the regulatory review that comes after the product leaves your site.

Stainless-steel bioprocess tanks in a pharmaceutical cleanroom
What's at stake

Three places where a validated
product still arrives compromised.

01

The gap between manufacturing and distribution

Your batch release is airtight. Your cold chain isn't always. That gap is where product is lost, delayed, or recalled, after it's already shipped.

02

Scale without SOP fragmentation

High volumes, multiple lanes, multiple depots. If every site runs a different cold chain SOP, you don't have a validated system, you have a patchwork.

03

Regulatory review follows the product

QP sign-off, FDA inspections, health authority queries. The cold chain documentation needs to be as complete as your manufacturing record.

How TempAid serves this lane

The same validation rigour
you apply to stability,
applied to the shipper.

01

ISTA 7D / 7E / 3A validated across all ranges

Refrigerated (2–8°C), CRT (15–25°C), and frozen (−15/−25°C). The same validation rigor you apply to your stability program, applied to your shipper.

02

GS1-labeled SKUs for traceability

Every configuration ships with compliant GS1 identification, traceable through your distribution network and readable by your logistics partners.

03

One SOP across your distribution network

Same assembly procedure, same refrigerant loading, same documentation from your domestic depot to your international distribution partner.

04

Custom validation for non-standard profiles

If your product's stability data doesn't fit the standard ISTA profiles, TempAid's Innovation Lab runs the custom qualification, summer/winter, any lane, any target range.

Boxes moving along a warehouse conveyor
Lab services

No two shipments are alike.We design for that.

If your shipment needs something the standard product line doesn’t carry, we’ll build it with you. We start by learning your lane, your warehouse conditions, your payload, and your temperature window.

Our in-house lab runs the testing, and we design the pack out around what we find. You get the test data, the qualification documentation, and a pack out built for your specific shipment. You’ll know before you commit.

Let’s Talk
The documentation story

A complete file,
not a conversation.

One qualification package, everything a QP or health authority reviewer needs to see, without a follow-up request.

01

ISTA test reports. 7D, 7E, 3A

As applicable. Signed, dated, full data set.

02

Qualification summary

Suitable for your distribution dossier or regulatory submission.

03

Pack-out SOP

Validated procedure, ready to implement across distribution sites.

04

GS1 labeling documentation

Item identification data for traceability integration.

05

Custom test report

If non-standard profiles required, full laboratory report on TempAid letterhead.

TempAid qualification report folder
Customer story

A mid-size manufacturer
brought distribution up to the
standard of its QA.

The situation

A mid-size pharmaceutical manufacturer distributing biologics through regional specialty distributors in North America and Europe.

The problem

Distribution cold chain didn't match the rigor of manufacturing QA, shippers with no validation data, inconsistent SOPs across depots, and a regulatory query after a health authority inspection.

What TempAid delivered

A Cube+ system with ISTA 7D/7E validation, GS1-labeled SKUs, and a standardized SOP deployed across four depots. The Lab ran a custom summer profile for the southern European distribution lane.

What changed

Distribution held to the same validation standard as manufacturing QA.

One SOP deployed across all four depot locations.

The last health authority inspection closed with no cold chain query.

What the clients are saying
“We stopped treating distribution as the step after QA. Now it’s held to the same standard, and the last inspection closed without a single cold chain query.”

Head of Quality, Mid-Size Pharmaceutical Manufacturer

Contact

The hard work is already done.

Tell us your temperature range and distribution lanes. We’ll specify the right system and deliver the documentation your regulatory team needs.

Get in touch