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Sample Quality Assurance Assignments 

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  1. As a QA Trainer with KRC Inc., you are to provide an orientation session for new employees describing the pharmaceutical manufacturing environment. Create a flow chart outlining the processes and critical controls involved in a pharmaceutical environment, from the time raw materials are received, to the manufacture of the product, and the shipping of the finished packaged product to consumers for use.  (Hint: Be sure to apply your knowledge of GMP regulations).
  2. As a Compliance Auditor with KRC Inc., you are to conduct an audit of the QC lab with a primary focus on reviewing laboratory records. Before your review of the laboratory notebooks, generate a brief report patterns outlining your future observations and suggestions for corrective actions.
  3. As a QA Documentation Associate with KRC Inc., you are to generate a raw material specification and a finished product specification for Product XXXX which will be supplied to the USA, testing and limits are to meet the requirements of the USP monographs. In addition, generate sampling documents specifying the amounts of raw material and finished products required to conduct full testing.

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