Page 2 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Training Outcome of the Module:
Testing laboratories provide a vital function with regard to provision of accurate
and reliable test results. Their customers rely upon these results to make
important decisions particularly in the areas of patient health, consumer
protection and the safety or suitability of materials, samples and products.
On completion of this module, you should be able to:
Recognize what comprises a laboratory quality manual.
Relate the safety requirements of the QC laboratory to day-to-day work
practices.
Distinguish between the different types of laboratory documents.
Stale the rules for record keeping and data recording.
Recognize the key features of test methods and specifications.
GLP (GOOD LABORATORY PRACTICES)
GLP generally refers to a system of management controls for laboratories and
research organizations to ensure the consistency and reliability of results as
outlined in the Organization for Economic Co-operation and Development
(OECD) Principles of GLP and national regulations.
GLP applies to non-clinical studies conducted for the assessment of the safety
of chemicals to man, animals and the environment.
According to 21 CFR 58:
" ... Nonclinical laboratory study [(GLP)] means in vivo or in vitro experiments
in which test articles are studied prospectively In test systems under
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