HOT TOPICS

Your PQS should be updated based on trends in the pharmaceutical industry. I can briefly show You hot topics for 2020, based on both my personal experiences and screening of available sources (FDA Warning Letters mainly):

1. Pharmaceutical Quality System

2. Impurities

3. Investigation, OOS

4. Data Integrity

5. Computerised Systems

6. VALIDATIONS (PROCESS, CLEANING, METHOD)

7. Continual Process Verification, Statistical Evaluation

8. Quality Risk Management

9. Supplier Evaluation

Screening across Warning Letters 2019 related to both manufacturers of active pharmaceutical ingredients and finished products have been performed in order to show trends in quality and what are the hot quality topics FDA is facing nowadays. Presentation is ready for You... just ask for details.