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.