Reference documents by CCM28 - Guidelines, Pharmacopeias, Publications, Handbooks, Technical reports, White papers.

Ley 26.492 Regulación de la cadena de frío de los medicamentos.

Argentina

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Standard test method for thermal insulation performance of distribution packages

ASTM

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Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM

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Code of good Wholesaling practice for medicines in schedule 2,3,4 and 8

Australia

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Guidance 14; Stability testing for prescription medicines

Australia

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Temperature excursions of biological medicines

Australia

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Codex für den Transport von Arzneimitteln in Österreich

Austria

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Transport: Best practice on transport qualification: good fistribution practice

Biophorum

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ANVISA guide 2/2017 V2 : Guidance on the Qualification of Transportation of Biological Products, April 12th 2017.

Brazil

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RDC resolution n°50, sept 20, 2011 Stability studies for biological products

Brazil

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RDC resolution 430, Oct 2020 Good practices of Distribution, Storage and Transportation of Medicines

Brazil

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GUI-0069, 2020, Guidelines for environmental control of drugs during storage and transportation

Canada

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GDP for APIs

Cefic/APIC

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CFDA 28, Provision for drug registration

China

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CFDA , Good Supply Practice for Pharmaceutical Products (Revised in 2016)

China

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DIS-15 version 4 Monitoring and control of storage and transportation temperatures for pharmaceuticals by manufacturers and wholesalers

Czech

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Standard operating procedures for pharmaceuticals good distribution and storage practices

Ethiopia

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Guidelines of 5 November 2013 on GDP of medicinal products for human use

Europe

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Guidelines of 5 November 2013 on GDP of medicinal products for human use. Q&A June 2018

Europe

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Wholesale Distribution of medicines within the EU/EEA (Danish Medicines Agency). Q&A November 2017

Europe

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Eudralex - volume 4 - GMP guidelines. Annexe 15 Qualification and validation

Europe

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Questions and answers on regulatory expectations for medicinal products for human use during the Covid-19 Pandemic

Europe

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ANSM - Bonnes pratiques de distribution des substances actives des médicaments à usage humain. Novembre 2015

France

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Temperature Control Regulations

IATA

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Guidance for Vaccine and Pharmaceutical Logistics and Distribution 5th Release

IATA

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Quality guidelines

ICH

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Guidelines on GDP for Biologicals Products

India

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Guide to GDP of Medicinal Producst for Human use

EIRE

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Good Practice Guide: Cold Chain Management

ISPE

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Good Practice Guide: Controlled Temperature Chamber Mapping & Monitoring

ISPE

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Guidelines for selecting and using ISTA Test Procedures and Projects

ISTA

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Pharmacopeia 17th edition

Japan

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The Supply Chain Manager's Handbook

JSI

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Guidelines for transportation of pharmaceuticals in Kenya. July 2019

Kenya

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Guidelines on good storage & distribution Practices of pharmaceutical products. 2017

Lebanon

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Good Cold Chain Management for temperature-sensitive pharmaceutical Products. 2017

Lebanon

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Guideline on Good Distribution Practice (Third Edition, 2018)

Malaysia

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Supplementary Notes on Annex 1: Management of Time and Temperature Sensitive Products (TTSP) of Guideline on Good Distribution Practice. January 2018

Malaysia

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National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 (2nd edition)

New Zealand

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National Guidelines for Vaccine Storage and Distribution. 2012

New Zealand

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AFDAC Good Distribution Practices Guidelines For Pharmaceutical Products. 2021

Nigeria

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Technical report 46. Last Mile: Guidance for Good Fistribution Practices for Pharmaceutical Products to the End User

PDA

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Technical report 52. Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain

PDA

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Technical report 53. Guidance for Industry: Stability Testing to Support Distribution of New Drug Products

PDA

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Technical report 58. Risk Management for temperature Controlled Distribution

PDA

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Technical report 64. Active Temperature Controlled Systems: Qualificaion Guidance

PDA

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Technical report 72. Passive Thermal Protection Systems for Global Distribution: Qualification and Opertaional Guidance

PDA

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Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1

PDA

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Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 2

PDA

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Technical Report 39 Revised 2021 Guidance for Temperature-Controlled Medicinal Products - Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment

PDA

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Manual de Buenas Practicas de Distribucion Y Transporte de Productos Farmaceuticos, Dispositivo Medicos Y Productos Saniarios

Peru

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Guide to Good Distribution Practice for Medicinal products

PIC/S

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Algorithm for actions of medical personnel in Emergencies Related to temperature Breaches during the transportation and storage of immunobiological medicinal products at the fourth levle of cold chain

Russia

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Regulations of requirements to storage conditions of thermolabil medicines in National Health care

Russia

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SAHPRA Good Wholesaling Practice for wholesalers (2016)

South Africa

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Good Storage and Distribution Practice

Saudi Arabia

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SFDA Guidance for the Storage and transport of Time and temperature Sensitive Pharmaceutical Products

Saudi Arabia

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HSA Guidance Notes on Good Distribution Practice

Singapore

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Western Pharmaceuticals Good Distribution Practice Regulations

Taiwan (Republic of China)

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Guide de bonnes pratiques de distribution et d'importation des produits pharmaceutiques à usage humain

UEMOA

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Guidelines on good Distribution Practice for Pharmaceutical Products (2018)

Uganda

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Green book chapter 3 Storage, distribution and disposal of vaccines. 2013

UK

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Vaccines stored outside the recommended temperature range. 2014

UK

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A practical example of applying Quality Risk Managment in GDP - Transportation Risks. 2020

UK

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ATP handbook

UNECE

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CDC Vaccine storage and handling toolkit, Feb 5, 2021

USA

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FDA Code of federal regulations Title 21 Subpart H Holding and Distribution

USA

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USP Excerpted USPNF standards vaccine handling Toolkit (chapters 659 / 1079 / 1079.2 / 1118)

USA

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USP 1083 Good distribution practices

USA

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USP 1083.1 Quality management system

USA

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USP 1083.2 Environmental Conditions Management

USA

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USP 1083.3 Good importation and Exportation Practices

USA

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USP 1083.4 Supply Chain Integrity

USA

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USP 1079 Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products

USA

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USP 1079.1 Storage and Transportation of Investigational Drug Products

USA

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USP 1079.2 Mean Kinetic temperature in the Evaluation of Temperature excursions during Storage and Transportation of Drug products

USA

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USP 1079.3 Monitoring Devices - Time, Temperature, and Humidity

USA

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USP 1079.4 Qualification od Storage areas

USA

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USP 1079.5 Qualification of Shipping Systems

USA

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USP 1079.6 Transport Route Profiling Qualification

USA

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USP 1079.7 Information Systems for Distribution Validation / Verification Studies

USA

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Normas de Buenas Prácticas para Almacenamiento de Productos Farmacéuticos, Materiales Médico-Quirúrgicos, Materias Primas, Productos Intermedios, a Granel e Insumos para Acondicionamiento

Venezuela

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Guidelines for the International packaging and shipping of vaccines. 6th edition. 2020

WHO

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Good storage and distribution practices Oct 2019 WHO Tech report series 1025 Annexe 7

WHO

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Technical report series No 961, 2011 Introduction

WHO

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Technical report series No 961, 2011 Supplement 1 Selecting sites for storage facilities

WHO

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Technical report series No 961, 2011 Supplement 2 Design of storage facilities

WHO

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Technical report series No 961, 2011 Supplement 3 Estimating the capacity of storage facilities

WHO

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Technical report series No 961, 2011 Supplement 4 Security and fire protection in storage facilities

WHO

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Technical report series No 961, 2011 Supplement 5 Maintenance of storage facilities

WHO

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Technical report series No 961, 2011 Supplement 6 Temperature monitoring of storage areas

WHO

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Technical report series No 961, 2011 Supplement 7 Qualification of temperature-controlled storage areas

WHO

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Technical report series No 961, 2011 Supplement 8 Temperature mapping of storage areas

WHO

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Technical report series No 961, 2011 Supplement 9 Refrigeration equipment maintenance

WHO

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Technical report series No 961, 2011 Supplement 10 Checking the accuracy of temperature control and monitoring devices

WHO

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Technical report series No 961, 2011 Supplement 11 Qualification of refrigerated road vehicles

WHO

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Technical report series No 961, 2011 Supplement 12 Temperature-Controlled transport operations by road and by air

WHO

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Technical report series No 961, 2011 Supplement 13 Qualification of shipping containers

WHO

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Technical report series No 961, 2011 Supplement 14 Transport route profiling qualification

WHO

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Technical report series No 961, 2011 Supplement 15 Temperature and humidity monitorin systems for transport operations

WHO

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Technical report series No 961, 2011 Supplement 16 Environmental management of refrigerant gases and refrigeration equipment

WHO

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Model Guidance for storage and transport TRS 961 Annex 9 2011

WHO

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Good Distribution Practices Guidelines.2017

Zambia

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