Lecture 7

Question 1

What areas are typically found deficient by the FDA during company inspections?

Answer 1

Quality System Deficiencies
Facilities and Equipment System Deficiencies
Materials System Deficiencies
Production System Deficiencies
Packaging and Labelling System Deficiencies

Question 2

What are examples of cGMP compliance issues found in FDA 483 notices or warning letters?

Answer 2

SOP Deficiencies: Missing Standard Operating Procedures for equipment cleaning validation, water sampling, media sterilization, etc.
Validation and Documentation Issues: Failures to validate changes, inadequate corrective actions, lack of continuous air pressure monitoring, missing specifications for LAF hoods.
Data Integrity Problems: Failing results not recorded, missing SOPs for data, failure to record sample weights, releasing raw materials with hazardous microorganisms.
Cleaning and Disinfection Issues: Lack of validation for cleaning Laminar Airflow Hoods, ineffective procedures for spore-forming organisms.
Investigation and Corrective Action Failures: Improper re-testing, inadequate documentation for failures, lack of investigation into particulate matter, and failure to follow cleaning procedures.
Other Compliance Issues: Deficient media growth promotion testing, lack of vendor qualification, labelling discrepancies, and failure to establish testing procedures.