Cold Chain management, a significant pharma efficacy process | Pharma...

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Cold Chain management, a significant pharma efficacy process

Written by: ptiblogadmin Written on: August 23, 2011 Comments Add One

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For pharmaceutical industry, cold chains assume significance due to the fact that many biologics and pharmaceutical compounds can get damaged with excessive heat or freezing during shipment, resulting in reduced efficacy. A cold chain, which is a temperature-controlled supply chain, is an uninterrupted series of storage and distribution activities which maintain a given temperature range. Although, common temperature range for a cold chain in pharmaceutical industries is 2 to 8 C., when it comes to specific temperature tolerances the levels largely depend on the actual product being shipped. The Good manufacturing practices (GMP) guidelines require that all processes that might impact the safety, efficacy or quality of the drug substance (drug and biological products) must be validated, including storage and distribution of the drug substance. Hence, this clearly suggests the growing importance and need for a well-established cold chain distribution process for pharma products, which are nothing but an extension of the GMP. The way in which vaccines, parenterals, biologics and human cell & tissue products are shipped from one place to another is called cold chain management. This process requires careful consideration, design, validation, and supervision at all levels considering various factors such as the type of shipping containers to be used, the distribution carriers to be contracted, what humidity control equipment is required (if any), the types of environmental conditions expected at each location along the distribution chain, the length and time of the distribution route etc. Unless and until the pharma manufacturer does not specify, distributors are bound to deliver medications to the hospital, clinic, or retail pharmacy maintaining the label temperature. Therefore, the packaging needs to maintain product temperatures accommodate ambient temperature and weather changes. This is especially important during the supply of vaccines by poor transport networks to distant clinics in hot and humid climatic conditions. In the last few years, driven by globalization of manufacturing practices, significant changes have occurred leading to increase in the complexity and vulnerability in the supply chain. There is a lack of clear guidance for shippers / distributors regarding regulatory expectations for ensuring that pharma products are not damaged or compromised during transportation. Without clear guidelines, risk of freezing during transportation increases and can affect the products leading to quality compromise and ultimately loss of profits. Hence, shippers today need to understand clearly the cold chain process as fully as possible to ensure the delivery of safe high quality pharma products. Here is a snapshot of important factors to be considered while selecting recording devices to test and validate the cold chain process: High accuracy temperature sensing performance Large memory to handle lengthy processes without missing readings Ability to measure and record both interior container temperatures and exterior conditions along the route Ability to operate without requiring an external power source and to keep accurate track of time and events across multiple time zones Uneven performance to handle the knocks, bumps, and widely varying environmental conditions of the shipping process Click Here For Complete List of Pharmaceutical Machine

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Cold Chain management, a significant pharma efficacy process | Pharma...

http://blog.pharmatechnologyindex.com/2011/08/cold-chain-managemen...

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