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GMP Inspection Readiness Checklist

Checklist are important to track or avoid any important points during routine work.

Below are the some Important points which helps in GMP inspection readiness.


  • Current Organograms
  • Copies of new and existing regulatory submissions.
  • Documents of recent regulatory agency inspection (reports and responses).
  • Site master file.
  • Facility floor plans.
  • Site equipment list.
  • SOP Index
  • Training records.
  • Master batch manufacturing records.
  • Flow chart for the entire manufacturing and packing process. Example executed batch record.
  • Equipment history records.
  • Change Control SOP and summary of any relevant process change.
  • Calibration SOP and Master calibration plan as well as summary of plan adherence along with calibration failure summaries.
  • Preventative Maintenance program SOP and Master schedule.
  • Summary of any manufacturing or specification change made as a result of API process change.
  • Deviation control SOP and summary of all product rejection, process failure and manufacturing deviation, reworks and reprocessing summaries including disposition of batches involved.
  • Validation Master Plan.
  • Computer System Validation Master Plan (CSVMP)
  • Process Validation reports.
  • Equipment qualification reports and area qualifications/validation in the manufacture of drug products.
  • APQR.
  • Cleaning validation reports for area/equipment used in the manufacture of drug products and written report detailing the rational for worst case, and cleaning endpoint/acceptable residue level.
  • Laboratory Information Management System (LIMS) validation reports.
  • LIMS Management procedure (pass, fail, retest criteria and responsibilities, report generation, etc.).
  • Raw materials, Excipients, component, In-process and Finished Material Specifications.
  • Analytical method validation reports for all testing procedures used during validation and manufacturing (including tests of incoming raw materials and packaging components).
  • Summary of overall percentage of laboratory test failures, including retests, for all products.
  • SOP for handling of OOS.
  • List of OOS by product being inspected
  • List of products supplied to US (for FDA).
  • Stability studies program including sample collection, storage, testing and summary including changes made in response to API change and any other changes to the process or method.
  • Plan of the water system, air handling (HVAC), Compressed air system, nitrogen system, and any other service systems supporting manufacturing.
  • Plans of the water system, air handling (HVAC)
  • Environmental monitoring summaries (trending) for production areas used for manufacturing.
  • Water system monitoring test result trends.
  • Microbiological specifications and testing procedures.
  • Vendor approval status for all suppliers of API, Excipients and packaging materials used in manufacturing.
  • Market complaints summary, procedure and investigation reports.
  • Summary of rejection of or complaints to suppliers of any materials used for manufacturing.

Hope this will helps......

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Location: India

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