Standard

ISPE ISPE Good Practice Guide: Cold Chain Management

May 2011 Published

Note: This standard has a new edition: ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

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Abstract

The new ISPE Good Practice Guide (GPG): Cold Chain Management covers a wide range of topics, including facilities, fixed cold rooms and freezers, temperature controlled shipping equipment, as well as guidance on mapping and monitoring, featuring practical technical guidance in all these areas, as well as addressing maintenance and cleaning with a section covering product traceability. Cold Chain is an area with increasing challenges to manufacturers, as the volume of products requiring controlled temperatures and the complexity of the supply chain for those products increase. The GPG will provide practical guidance and examples of typical documents in the area of cold chain management.

Document information

Standard from ISPE
Published: 1 May 2011
Version: 0
Document type: IS
ISBN:

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Version history Related corrigendum and amendments (0)

Version history History (45)

ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

ISPE ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems

ISPE ISPE Good Practice Guide: Validation 4.0

ISPE ISPE Good Practice Guide: Digital Validation

ISPE ISPE Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition

ISPE ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems

ISPE ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) Second Edition

ISPE ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations

ISPE ISPE Good Practice Guide: Process Gases, Second Edition

ISPE ISPE Good Practice Guide: Containment for Potent Compounds

ISPE ISPE Good Practice Guide: Membrane-Based Water Injection Systems

ISPE ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

ISPE ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification Mapping and Monitoring

ISPE ISPE Good Practice Guide: Good Engineering Practice, Second Edition

ISPE ISPE Good Practice Guide: Maintenance

ISPE ISPE Good Practice Guide: Equipment Reliability

ISPE ISPE Good Practice Guide: Critical Utilities GMP Compliance

ISPE ISPE Good Practice Guide: HVAC and Process Equipment Air Filters

ISPE ISPE Good Practice Guide: Asset Management

ISPE ISPE Good Practice Guide: Process Validation

ISPE ISPE Good Practice Guide: Single-Use Technology

ISPE ISPE Good Practice Guide: Technology Transfer

ISPE ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities

ISPE ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases

ISPE ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring

ISPE ISPE Good Practice Guide: Management Engineering Standards

ISPE ISPE Good Practice Guide: Operations Management

ISPE ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems

ISPE ISPE Good Practice Guide: Technology Transfer

ISPE ISPE Good Practice Guide: Clinical Supply Systems

ISPE ISPE Good Practice Guide: Booklet Labels

ISPE ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)

ISPE ISPE Good Practice Guide: Quality Laboratory Facilities

ISPE ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems

ISPE ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities

ISPE ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment

ISPE ISPE Good Practice Guide: Comparator Management

ISPE ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry

ISPE ISPE Good Practice Guide: Interactive Response Technology

ISPE ISPE Good Practice Guide: Process Gases