cGMP (Current Good Manufacturing Practice) Checklist:
Facilities and Equipment:
Are all facilities and equipment suitable for their intended use and properly maintained and calibrated?
Is there a cleaning and sanitation program in place for all facilities and equipment?
Are all facilities and equipment designed to prevent contamination and cross-contamination?
Is there a proper temperature, humidity and lighting control in place?
Does all equipment have valid calibration and preventive maintenance records?
Personnel:
Are all personnel properly trained and qualified for their roles?
Are there written procedures for personnel training, qualifications, and job responsibilities?
Are personnel aware of their responsibility to report any deviations or problems?
Are employees using personal protective equipment (PPE) when necessary?
Production and Process Controls:
Are there written procedures for all production and process controls?
Are all critical steps in the manufacturing process validated?
Are there adequate controls in place to ensure the consistent quality of raw materials and finished products?
Are there specifications, testing methods, and process controls for each component, in-process material, and drug product?
Are you maintaining master production records for all products?
Quality Control:
Are there written procedures for sampling and testing of raw materials, intermediates, and finished products?
Is there a system in place for handling and investigating out-of-specification test results?
Is there a system in place for controlling non-conforming products?
Are there procedures for Quality Control units to approve or reject all component, packaging, and labeling materials?
Record Keeping and Documentation:
Are there written procedures for record keeping and documentation?
Are all records and documents legible, accurate, and complete?
Are records and documents retained for the appropriate time period?
Are records, such as batch production and control records, maintained to demonstrate that each batch has been produced and tested in accordance with the current GMP regulations?
Complaints and Adverse Events:
Are there written procedures for handling complaints and adverse event reporting?
Is there a system in place for investigating and documenting complaints and adverse events?
Are procedures established to receive, review, and evaluate complaints?
Self-Inspection:
Is there a program in place for regular self-inspection to ensure compliance with cGMPs?
Are there written procedures for self-inspection and are they followed consistently?
Continuous Improvement:
Is there a program in place for continuous improvement to ensure that cGMPs are always met and exceeded?
Are there written procedures for monitoring and evaluating the effectiveness of cGMPs?
As with GMP, this checklist is meant to be a general guide for cGMP compliance. It's important to consult the relevant FDA regulations and guidelines, and work with a qualified consultant if needed to ensure full compliance with cGMP regulations.
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