CRED Practical Document Writing and Management

Module 2 - What Makes a Good Quality Overall Summary (this is NOT a question!)  Follows scope/outline of body of data in Module 3

 Short, concise

 No new data/information

 Aim to provide Quality Assessor with a critique of M3:  Rather than a ‘cut and paste version of M3  Emphasize critical key parameters of drug substance/product  Provide justification where guidelines not followed  Discuss key issues which integrate information from Quality module and supporting information from other Modules e.g. qualification of impurities via toxicological studies included in Module 4, Non-Clinical.

 Make it worth reading!