Clinical Operations-Design to Execution

BayBiotech.NET Through the ICH process (ICH M4Q), considerable harmonization has been achieved among the three regions (Japan, EU and US) in the technical requirements for the registration of pharmaceuticals for human use. To avoid the need to generate and compile different registration dossiers, the ICH: M4 guideline describes a format for the Common Technical Document that will be acceptable in all three regions. In a nutshell, CTD is an internationally agreed upon format for the preparation of a presentation for applications to be submitted to the regulatory authorities. However, the CTD does not address the content of submissions. There are many regional requirements, as well as applicants’ preferences, that could affect the contents of dossiers submitted in each region. According to the ICH guidelines, a document is defined for a paper submission as a set of pages, numbered sequentially and divided from other documents by a tab and a document can be equated to a file for a...

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 imple...