About This Manual

Parent topic: Introduction

Purpose

The information in this manual is provided to assist owners, operators and service people for GDP qualification of equipment with temperature controlled unit for the transport of pharmaceutical products.

This GDP Qualification Documentation is in line with the EU guideline of Good Distribution Practices of medical products for human usage (GDP) and annex 15 “Qualification and Validation” of the Good Manufacturing Practice for Medicinal products for Human and Veterinary Use (GMP).

Units covered in this manual are Thermo King Single-Temperature A400, A500 and A–500e.

Units covered in this manual are: Thermo King Trailer Multi-Temperature Units: A-500 Spectrum and S3A remote evaporator in ZONE 2.

Note This document is only valid in conjunction with the GDP qualified equipment certificate and is qualified on completion of the qualification process. This Certificate should be stored in the supplied pouch at the front of this manual along with the GDP Approval letters by Independent pharmaceutical company.

Contents

GDP Qualification Documentation

This manual is organized into the following chapters:

Chapter Purpose
Certificate of the equipment qualified GDP compliant Validation of the Installation Qualification for specific equipment.
Note (To be inserted in pouch provided at the front of this Manual.)
GDP Approval letter by Independent pharmaceutical company

  • Validation of Thermo King GDP Protocol.

  • Qualification and Validation of standard equipment

Note (To be inserted in pouch provided at the front of this Manual.)
Qualification Plan Summarizes the minimum information that is included in this qualification report, Purpose, User Requirements Specifications, stages of qualification, qualification method, and responsibilities.
Risk Assessment Identifies sensible measures to control the risks during the transport of pharmaceutical products with temperature controlled equipment.
Design Qualification Lists equipment specifications and provides a documented verification that the proposed design of the equipment is suitable for the intended purpose.
Installation Qualification Confirms that the equipment is installed and conforms to the approved design qualification and the manufacturer's recommendations.
Operational Qualification Confirms that the equipment performs as intended throughout the anticipated operating ranges and provides operating guidance.
Performance Qualification Provides temperature mapping test results that prove that the equipment can perform effectively and reproducibly, based on the approved process method and product specification.
Certification Certificate of Approval of Trane Technologies Quality Management system.

Contacting Thermo King Service

Before you call Thermo King Service, have the following information on hand (for exact data see serial plate on your unit):

  • Unit Type (commonly typed on serial plate after code DESC)

  • System or Model number (commonly coded on serial plate after Barcode)

    • All advancer models are covered under model/system number TKTRLA + 8 digits)

  • Serial Number

Who to call: Your Thermo King Dealer Representative or Thermo King Service Center.

Blank Pages

This manual may contain blank pages at the end of chapters. This is normal. There is no information missing from the manual.

Roadside/Curbside Terminology

Roadside/Curbside terminology: These terms can be confusing because of differences between North America and Europe. Please note:

Curbside: The side of the truck to the driver’s right when the driver is in his seat and facing forward.
Roadside: The side of the truck to the driver’s left when the driver is in his seat and facing forward.