Ordnerverwaltung für Regulatories for Biotechnologies for Life Sciences
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What is PQR and what APR?
Product Quality Review
Annual Product Review
Annual Price Review
Product Quality Revenue
Annual Price Revenue
What is CAPA?
Corrective and Preventive Action (CAPA) is a Quality Management System (QMS) process
9. Define within each sentence, what is biosafety, what is biosecurity?
Biosafety is the prevention of large-scale loss of biological integrity, focusing on ecology, and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety is used to protect from harmful incidents. Many laboratories handling biohazards employ an ongoing risk management assessment and enforcement process for biosafety.
Biosecurity refers to measures aimed at preventing the introduction and/or spread of harmful organisms (e.g. viruses, bacteria, etc.) to animals and plants in order to minimize the risk of transmission of infectious disease.
12. Wildtype E.coli is a widely spread bacterium for life science applications. Unfortunately, it is indicated with biosafety level 2. Please describe the procedure for risk assessment and an alternative in practice for level 1.
First stage: Definition of context: Legal framework, Protection goals, Project Objectives, Biology of Bacterium, Receiving medium, Track record of safe use
Second stage: Formulation of the problem and hazards list
Pro-Tip: Work with a bacterial strain of lower biosafety level.
Risk group 2: E. coli Wildtyp
E.g. E. coli K-12: common laboratory strain e.g. used for cloning experiments. No pathogenic factors. Risk assessment: S1 (same for E. coli XL-1 blue)
12.b Wildtype E.coli is (...) indicated with biosafety level 2. Please describe the alternative in practice for level 1.
What he said: planning to work with a bacterial strain within the lowest biosafety level. E.g. E. coli Wildtyp to E. coli XL-1 blue or E. coli K-12.
13. Quality control is part of QMS. Please name at least 4 arrangements for quality control in the field of Life sciences.
QC (e.g. calibration, document)
QC (e.g. SOP)
14. Name the current ISO for QMS. What is a notified body?
A notified body, in the European Union, is an organization that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are published in European directives or regulations. More generally, a notified body is an independent, accredited body that is entitled to an authorized accrediting body. Upon definition of standards and regulations, the accrediting body may allow a notified body to provide verification and certification services. These services are meant to ensure and assess compliance to the previously defined standards and regulations, but also to provide an official certification mark or a declaration of conformity
10b. Benches and autoclaves are the most relevant equipment in labs within the biosafety label. Please describe the technical and administrative arrangements, which must be under attendance that you are allowed to work with?
Technical: Annual check of the filters Label, Benches with class 2 Autoclave with spore tests.
Administrative: labeling of the working area access only for authorized lab members operation instructions arrangements for accidents regular biosafety lectures for the lab members documentation of all the lab work Hygiene plan