NEWS

Regulatory Harmonization Efforts

APAC countries are increasingly aligning their regulatory frameworks with global standards to facilitate smoother market access for pharmaceutical products.

NEWS

Focus on Quality Management Systems

Regulatory bodies in APAC are emphasizing the importance of robust quality management systems to ensure compliance and product safety.

NEWS

Emerging Market Trends

The APAC region is witnessing significant growth in biotech and generic drug markets, necessitating updated regulatory strategies.

ARTICLE

Navigating FDA CGMP Compliance in 2025

As we approach the end of 2025, understanding FDA's current Good Manufacturing Practice (CGMP) regulations is crucial for pharmaceutical companies. With nearly 15,000 inspections conducted annually, maintaining compliance is a priority. Over...

REGULATORY · FDA

CGMP Inspections: Current Landscape

FDA prioritizes postmarket surveillance inspections to ensure compliance and patient safety. Facilities must be prepared for thorough inspections that assess risk management strategies.

REGULATORY · FDA

Response to Form FDA 483 Observations

Companies must address observations noted in Form FDA 483 within 15 business days to avoid escalation. High open CAPAs signal potential compliance issues.

REGULATORY · FDA

Risk-Based Inspection Models

FDA uses a risk-based model for inspections, focusing on facilities with higher risks. This approach aims to mitigate issues before they affect patient safety.