SOP Posts

Managing CAPA Requires a Strong SOP

Mark Crawford

According to Nancy Singer and Mark Lagunowich in their informative MD+DI article entitled “Getting Your CAPA House in Order,” CAPA (Corrective and Preventative Action) remains one of the top FDA 483 citations year after year, due typically to “either inadequate processes or inconsistent adherence to processes,” they write. “This includes failing to define which issues should or should not be elevated to CAPA status, insufficiently documenting the data required by FDA to adequately assess the CAPA’s effectiveness, or relying on outmoded systems to collect and analyze the data and demonstrate that the firm is operating in a state of control.” (more…)

Do You Know Where Your Documents Are?

Mark Crawford

According to the FDA, six words not to utter on FDA inspection day are: “Now, where is that darn document?” (It’s nice the FDA has a sense of humor, at least on paper).

Kidding aside, this is a big-enough issue that the FDA recently offered a seminar to alleviate problems such as:

  • Unscanned paper documents
  • Confusing naming conventions
  • E-mails as documentation
  • Non-functional or non-existent SOPs
  • Missing documents