Increasing volumes of cold products, the complexity of these products, and the complexity of the associated supply chain are causes for concern. Organizations need adequate control over cold chain of pharmaceutical and biopharmaceutical distribution systems. ISPE recognized the need for guidance in this area a dedicated team of subject matters experts from across the pharmaceutical and biopharmaceutical industries developed the ISPE Good Practice Guide: Cold Chain Management.
This Guide provides tools and strategies for Cold Chain Management and to complement work by the Guidance for Temperature Controlled Medicinal Products. It helps to develop, establish, document, implement, maintain and improve industry good practice for product requiring controlled cold conditions. The Guide is intended to provide practical guidance to assist in the specification, design, commissioning and verification of the fixed and passive systems within the cold chain.
The Guide is intended to provide a robust cost effective system to ensure safe, effective product is received by the end users. The Guide covers the process from the point of entry into the manufacturers' controlled temperature storage facility after being packaged through delivery to the distributor or customer premises. Collaboration by team members and the PDA has helped to ensure that guidance is aligned with forthcoming PDA guidance documents. It makes reference to:
ICH Q8, Product Development
ICH Q9, Quality Risk Management
ICH Q10, Pharmaceutical Quality Systems
ASTM E2500 "Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment"
ASTM E2537 "Standard Guide for Application of Continuous Quality Veriﬁcation to Pharmaceutical and Biopharmaceutical Manufacturing"
Cold chain management is part of the life cycle of a regulated company and understanding the requirements of the cold chain process will help to focus efforts to ensure that: activities add value, solutions are based on robust science, and undergo appropriate risk assessment; therefore, meeting the expectations of the regulators and ultimately provide protection to the patient.
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