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......