A PRACTICAL LOOK AT FDA'S GOOD MANUFACTURING PRACTICE (GMP) REGULATIONS. REVIEW 483 OBSERVATIONS FROM FDA INSPECTIONS
GMP Trends® publishes several reports to help you prepare for FDA Inspections. They are The GMP Trends® Newsletter, The GMP Trends® Annual Trend Report and The GMP Trends® Inspected Facilities List. Use these reports to:
- Spot vulnerable areas before they become compliance issues.
- Enhance your internal & supplier audit programs.
- Educate your team about new quality issues and trends.
- Create training programs based on the trends.
The GMP Trends® Newsletter includes:
- Relevant 483 observations edited for significance.
- Published twice monthly.
- Includes global FDA inspection information.
- Available online or in print.
- Archives of newsletter available for review.
The GMP Trends® Annual Report on FDA Inspection Observations includes:
- Review of FDA Inspections each Fiscal Year.
- Examples of cited observations from actual Form 483s.
- Trend of top cited observations for Drug and Device Facilities.
- Report published once per year in Q1.
The GMP Trends® List of FDA Inspected Facilities is:
- A list of the drug and device facilities inspected by the US FDA.
- Includes Domestic and Foreign Inspections.
- Details length and outcome of inspection.
- Report published quarterly.