Good manufacturing practices (GMP)—are system that ensures products are consistently produced according to quality standards—is a concept most in the biotech industry are familiar with. But what exactly is clinical GMP? Clinical GMP specifically refers to the guidelines associated with products intende...
What is GMP? GMPstands for Good Manufacturing Practices. They are the practices required in order to conform to the guidelines recommended by the agencies that control the authorization and licensing of the manufacture and sale of food, beverages, cosmetics, pharmaceutical products, medical devices, ...
Biotech, and particularly the field of biopharmaceuticals, is growing fast and will constitute more than 50% of the pharmaceutical drug market by 2020. Biopharmaceuticals include a broad range of types requiring different production technologies. Most manufacturing methods utilise either microbial or mammal...
Evive’s signature DiKineTMplatform is a mature and versatile platform that manufactures therapeutic dimeric human cytokines, hormones or their agonist/antagonists with extended circulating half-life for improved clinical benefit. The DiKineTMplatform has been implemented at Evive's Beijing GMP manufacturi...
TrademarkHNB BIOTECH OriginChina-Xian CAS51-17-2 Molecular Weight118.14 Molecular FormulaC7h6n2 Einecs200-081-4 Product Description Benzimidazole 99% Powder for sell CAS 51-17-2 Benzimidazole is an organic compound with the chemical formula C7H6N2. It is crystalline in flak...
TrademarkMagen Biotech OriginChina Main FunctionsIsolation up to 10mg Endotoxin-Free Plasmid DNA Applications1Cell Transfection, Animal Injection, etc. Purification Method1Mega Spin Column Purification TechnologySilica Technology Process MethodManual (Centrifugation or Vacuum) ...
But it also needs to do all this in such a way that is lightweight, flexible and realistic for your business to implement. Consider the weightier eQMS systems on the market designed for large scale pharma firms, the amount of time they take to set up, the weeks and months involved in ...
OOS (Out of Specification) refers to a product that does not meet the established specifications as expected. OOS investigation determines the actual cause of the results.
EMA GMP Chapter 4states that: Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be fully defined in the manufacturer’s Quality Management System. Documenta...
About Medomics Jiangsu Medomics Medical Technology Co., Ltd., is located at Biotech and Pharmaceutical Valley of the National Jiangbei New Area, Nanjing, Jiangsu Province. It is an international high-tech enterprise driven by innovation in the area of medical devices R&D...