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Preparing a Quality Manual                                                               

 

Situation

 

A European-based pharmaceutical firm wanted to develop an integrated set of quality procedures for its worldwide development activities. The firm wanted the procedures to meet FDA and European GMPs as well as ISO-9000 expectations.

 
LearningPlus Response
  LearningPlus collaborated with the firm and other external resources and wrote more than 20 quality policies that are included in its policy manual.
 

Outcome

  The firm has issued policies to its sites and its Quality Assurance division will soon begin auditing the sites against the expectations.