Introduction The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonization through the development ..
Introduction Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that ..
The following is a list of steps to place a B12 shot yourself. Wash hands and lay out what you will need. Lay down a paper towel for your workspace Place the following onto your paper towel: alcohol wipes or a cotton ball with alcohol, B12 prefilled injectable syringe, and the needle that comes in ..
At the July 2003 ICH meeting in Brussels an arrangement was reached on a common vision and approach for developing an international plan for a harmonized pharmaceutical quality system that would be applicable across the life-cycle of a product. Among other actions that were outlined to implement this vision, an expert working group was established ..
What is GxP? GxP are the quality standards and regulations for a specific field or activity. GxP revolves around two main regulatory pillars: accountability and traceability. Accountability refers to the ability to demonstrate what each person has contributed to a product or project and when they contributed it. Traceability means that there needs to be ..
Endotoxins may become pyrogenic when released into the bloodstream or other tissue where they are not usually found. Although the colon contains Gram-negative bacteria in abundance, they do not cause a pyrogenic effect as the bacteria are not undergoing gross lysis, and the immune system is not exposed to free endotoxin while the colonic wall ..