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Manuf Lec

Lesson 3 (GLP)

QuestionAnswer
It is the act of giving confidence assurance
It is the state of being certain or the act of making certain assurance
The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled quality assurance
An evaluation to indicate needed corrective responses control
The act of guiding a process in which variability is attribute to a constant system of chance causes control
The observation techniques and activities used to fulfill requirements for quality quality control
A day to day control of quality within a company for the approval or rejection of completed dosage forms quality control
It is a responsibility of an organization to determine that systems, facilities and written procedures are adequate and followed in oder to assure that products are controlled and will meet quality assurance
A set of activities for ensuring quality in the processes by which products are developed QA
It focuses on defect prevention QA
It is process oriented QA
A set of activities for ensuring quality in products QC
It focusses on defect identification QC
It is product oriented QC
Examples to avoid cross contamination a. production segregated areas b. airlocks and air extraction c. minimizing the risk of conta. caused by recirculation d. protective clothing e. using cleaning and decontamination procedures f. using closed systems of productions g. testingofresidue
NDA stands for new drug application
It is a quality system concerend with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archibed and reported GLP
Primary Purpose: product safety and quality GMP
It applies to manufacturing GMP
Primary Purpose: data quality and study reliablity GLP
It applies to preclinical R&D GLP
OECD Organization for Economic Co-Operation and Development
It is a unique forum where the governments of 30 democracies work together to address the economic, social and environmental challenges of globalization OECD
Ir provides a setting where goverments can copare policy experiences, seek answers to common problems, identify good practice and work to co-ordinate domestic and international policies OECD
Enumerate the countries where OECD members belong Austrilia Austria Belgium Canada Denmark Finland France Greece
What are the 2 references of GLP OECD and WHO
Created by: kateperryy
 

 



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