A management system direct and control an organization by policy and objective with regard to bio-quality. Bio-quality is the degree to which a set of inherent properties of a product, system or process fulfills biotechnology related requirements including bio-risk, bio-safety and bio-security. For biotechnology related product, system or process, it has almost operated in laboratory environment such as biochemistry test, microbiological / culture study, DNA & RNA recombination, GMO study, etc.
Bio-risk is the probability of an adverse health effect as a result of exposure to a biohazard substance. The risk involves interactions among agent, host and environment. Therefore, a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product life cycle and safety, as well as, security should be concerned.
Laboratory Bio-safety could be interpreted as containment principles, technologies and practices to prevent unintentional exposure to pathogens and toxins, or their accidental release.
Laboratory Bio-security could be interpreted as institutional and personal security measures designed to prevent loss, theft, misuse, diversion or intentional release of pathogens and toxins. Laboratory Bio-security touches many area including physical security, personnel security, material control & accountability, transport security and information security.
Therefore, Bio-QMS is an integrated management system to ensure safe handling and free contamination risk of micro-organisms and the products of biological processes through the establishment and implementation of the policies on bio-quality (bio-risk, bio-safety and bio-security).
The followings photos show a simulation handling process of bio-agent spill in BSL3 lab.
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