Pharmexcellearning.com

  • We review, investigate  any Major or Critical Pharma , API , FMCG any industry .
  • Common problem  SOP not followed.  
  • Data integrity issue .
  • Failure in process parameter.
  • High speed of machine.
  • Insect in facility.
  • Issue in master document.
  • Document missing.
  • In process test missing.
  • FIFO not followed.
  • Any other type.
  • Line clearance issue

The primary purpose of a deviation investigation report in a GMP environment is to clearly and concisely demonstrate that the root cause of the deviation has been identified; corrective actions have been taken; and that safety, integrity, strength (potency), purity, and quality (SISPQ) of the product has been ensured.