Skip to main content

ISO 22000: Food Safety Management System (FSMS)

BayBiotech.NET

ISO 22000 is a food safety management system standard that defines a set of general food safety requirements that apply to all organizations involved directly or indirectly in the food chain. ISO 22000 requires establishing a food safety management system (FSMS) to ensure that food products do not cause adverse human health effects.
ISO 22000 is designed to be used for certification (registration) purposes. However, the certification is not required. This includes every step from initial production to final consumption. More precisely, it includes the production, processing, distribution, storage, and handling of all food and food ingredients.
Main objectives of ISO 22000 is to plan, implement and establish a food safety management system in order to ensure that products do not cause adverse health effects by demonstrating compliance with legal safety requirements.
ISO 22000 uses almost the same basic structure as the ISO 9001 hence the organizations that have implemented ISO 9001 have an easier understanding of ISO 22000 planning and implementation.
References: 1. http://www.iso.org/iso/catalogue_detail?csnumber=35466
2. http://www.praxiom.com/iso-22000-intro.htm

Comments

Post a Comment

Popular posts from this blog

Risk Based Clinical Monitoring

BayBiotech.NET FDA's recommendation of Risk Based Monitoring of Clinical Trials , as published in their Draft Guidance in August 2011. For the first time, FDA provided guidance on monitoring of clinical investigations in 1988 which was recently withdrawn, stated that the “most effective way” to monitor an investigation was to “maintain personal contact between the monitor and the investigator throughout the clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to effect meaningful communication with investigators other than through on-site visits.   This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying crit...
1 comment
Read more

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