The following questions quiz the reader on the FDA Guidance for Industry Process Validation: General Principles and Practices. Readers are encouraged to utilize these questions as part of site training programs on process validation to assess employee understanding of the guidance. Comments and suggestions regarding these questions are most welcome. Please contact Paul Pluta, journal editor-in-chief, at [email protected], or Cale Rubenstein, community manager, at [email protected], with comments.
|Pass rate:||80 %|