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- Biologicals - World Health Organization (WHO)
Biological therapeutics, also referred to as Biologicals, are those class of medicines which are grown and then purified from large-scale cell cultures of bacteria or yeast, or plant or animal cells Biologicals are a diverse group of medicines which includes vaccines, growth factors, immune modulators, monoclonal antibodies, as well as
- Guidelines for Biologicals - World Health Organization (WHO)
Guidelines for national authorities on quality assurance for biological products, Annex 2, TRS No 822 18 October 2015 Guidelines on procedures and data requirements for changes to approved vaccines, Annex 4, TRS No 993 Guidelines on procedures and data requirements for changes to approved vaccines, Annex 4, TRS No 993
- WHO good manufacturing practices for biological products
present in raw materials, media, biological substances, intermediates or finished products Regarded as contamination when the level and or type exceed specifications Biohazard: any biological material considered to be hazardous to people and or the environment Biological starting materials: starting materials derived from a biological
- IARC Monographs on the Evaluation of Carcinogenic Risks to Humans . . .
Overview Volume 100 of the IARC Monographs, A Review of Human Carcinogens, covers all agents previously classified by IARC as "carcinogenic to humans (Group 1)" and was developed by six separate Working Groups: Pharmaceuticals; Biological agents; Arsenic, Metals, Fibres, and Dusts; Radiation; Personal Habits and Indoor Combustions; Chemical Agents and Related Occupations
- Health products policy and standards - World Health Organization (WHO)
The catalogue of international reference standards for biological products is updated following the Expert Committee on Biological Standardization meetings See below for the catalogue, listed in alphabetical order and includes additional information Alphabetical list
- Biological weapons - World Health Organization (WHO)
The use of biological agents is a serious concern, and the risk of using these agents in a terrorist attack is thought to be increasing Preparedness WHO focuses on the possible public health consequences of an incident due to a biological agent, regardless of whether it is characterized as a deliberate act or a naturally occurring event
- Laboratory biosafety manual, 4th edition - World Health Organization (WHO)
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis
- Guidelines on clinical evaluation of vaccines: regulatory expectations
These WHO Guidelines are intended to replace the WHO Guidelines on clinical evaluation of vaccines: regulatory expectations, which were adopted by the Expert Committee on Biological Standardization in 2001 (1) The document of 2001 provided guidance on the clinical evaluation of vaccines as well as on WHO vaccine prequalification
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