Wednesday, February 18, 2009

Pre Approval Inspection and things to look for

Following are the key things you should look for pre approval inspection.

  1. Deviations, OOS, product failures
  2. Investigations and CAPA’s
  3. Label control
  4. QA oversight
  5. Management oversight
  6. Drug Safety and Pharmacovigilance projects
  7. Process, shipping cleaning method
  8. Vendor and contractor qualification and oversight

Deviations gives the indication of break down in one or all of the following:Equipment, processes, SOP’s, training, culture, QA or management oversight
Product failures are indicators of one or more of the following:Equipment, processes, SOP’s, training, culture, QA or management oversight as well as testing, specifications and change control

Investigations contain following things

  • Depth of root cause analysis
  • asking all the questions
  • is the documentation Adequate
  • A recurring theme and if so why“Super investigation” initiation
  • Adequate time allocated Investigation completed in a timely manner
  • Management awareness of issues


  • Point issue versus holistic solution
  • Logical and encompassing CAPA’s
  • CAPA effectiveness – evidence
  • Adequate time allocated
  • Recurring issues – is the CAPA a cut and paste
  • SOP rewrite and training do not solve all problems
  • Management awareness of issues – did they act in a timely fashion

Label Control

  • Largest reason for recall
  • Processes for master labeling control must be adequate
  • Label control on production floor must be defined and followed
  • Labelers and packaging lines must be validated
  • Process history must support operations

QA Oversight/Mgt Oversight

  • Very clear in Warning Letters but sometimes hidden in 483’s
  • QA disposition lots not a committee
  • QA’s role in stopping production
  • QA reporting relationship –org charts must represent real life
  • Discretionary budget
  • QA’s voice at the right table
  • Does the senior person on site know what is going on
  • This could be the CEO
  • Does the head person hear the good and the bad news and from whom

Validation (Proc, Ship, Clean & QC )

  • Is it a living discipline? Or is it a paper hurdle?
  • Is validation a one time activity?
  • Development reports must support validation which supports batch records
  • Validation is not a development activity
  • Validation must support what you claim for your process
  • Methods used, in compendial, must be valid
  • Deviations in the reports must be addressed

For detailed explanation of above points i would recommend the training.

Preparing for FDA Pre-Approval Inspections

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