Skip to main content

Cold Chain Management: Good Practices

BayBiotech.NET

Cold chain management is a temperature-controlled supply chain management to insure an unbroken and uninterrupted series of storage and distribution activities which maintain a given temperature range.

Cold chain management is used to extend the shelf life as well as to protect the temperature sensitive products such as fresh produce, photographic films, meat products and medicinal products from damages caused due to inappropriate temperature regulations during processing, delivery and storage.

Food industry uses the process of Hazard Analysis and Critical Control Point (HACCP), as a useful tool, however, its usage continues into other fields such as Pharmaceutical Industry. HACCP process identifies key action points known as Critical Control Points that are used to lower the hazardous risks.

HACCP is based on seven principles. The seven principles are: (1) hazard analysis, (2) critical control point identification, (3) establishment of critical limits, (4) monitoring procedures, (5) corrective actions, (6) record keeping, and (7) verification procedures. (http://www.fsis.usda.gov/OA/background/keyhaccp.htm)

ISO 22000 is based on the seven HACCP principles which is a complete food safety management system incorporating the elements of prerequisite programmes for food safety, HACCP and quality management system . Within United States, HACCP compliance is regulated by 21 CFR parts 120 and 123.

To read more about Good Cold Chain Management Practices follow the link: http://www.carrymed.com/site/alcms/file/Rafik_Bishara.PDF

Comments

Post a Comment

Popular posts from this blog

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of...
1 comment
Read more

eCTD Submission Specifications

BayBiotech.NET The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. eCTD technical document format development was done by International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Details on the specification for the ICH eCTD can be found in the guidance document M2 eCTD: Electronic Common Technical Document Specification. Currently, eCTD is the preferred format for electronic submissions by U.S. Food and Drug Administration. Although originally the CTD and the eCTD were designed for marketing applications, they could apply equally to other submission types, including INDs, master files, advertising material, and promotional labeling. In June 2008, FDA has issued guidelines for organizing the electronic regulatory document filing using the eCTD tools. This guidance discusses issues related to the electronic submission of applications for hum...
Post a Comment
Read more

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...
Post a Comment
Read more