Category Archives: Pharma Inspection

Do’s:  • Answer all questions honestly; • Say “I don’t know” or “I’ll get the answer for you;” • Avoid such phrases as “I think,” “Sometimes/often/usually,” “never” and “next time;” • Avoid qualifiers, such as “typically,” “normally,” “generally” and “usually;” • Stop speaking once the question is answered;  • Ask for explanations or interpretations ofContinue reading “Do’s and Don’ts During FDA Inspection”

What is QSIT? QSIT provides guidance to the FDA field staff on the inspection process used to assess medical device manufacturer’s compliance with quality system regulations. An FDA quality system inspection technique audit focuses primarily on four major subsystems and their respective documentation samples and is an efficient way to determine systemic weaknesses. When anContinue reading “You must know Inspection Techniques that followed by your next Inspectors”