CAPA system enables organizations to address deviations and prevent recurrence to maintain product quality and regulatory compliance. Regulatory Requirements For Complaints and Recalls, requires a formal CAPA system for managing complaints and recalls to prevent recurrence Key Steps of CAPA Identification Evaluation Investigation Action Plan Implementation Verification & Effectiveness Check Closure Roles and Responsibilities Best…
In highly regulated environments, Change Control is vital for ensuring product quality and compliance with stringent regulations. Regulatory Rquirements FDA: EMA: ICH Q10: Types of Changes: Classification of Changes: Key Components of Change Control: Roles and Responsibilities: Best Practices: Read also: Resource Person: Alaaeldin Rashad
Checklist for Site transfer (Technology Transfer) products includes (but not limited to): Read also: Resource Person: Ammar Idries
Quality excellence is the commitment to consistently meet standards by continuously improving processes, reducing errors, and delivering high-quality products to ensure patient safety, regulatory compliance, and operational efficiency. However, achieving quality excellence doesn’t always require major overhauls; small, strategic adjustments can make a powerful impact. Here are some actionable tips to boost quality performance today!…
Effective recall management enables organizations to ensure swift and effective removal of potentially harmful or non-compliant products, protecting public health and ensuring regulatory compliance. Regulatory Requirements Types of Recalls Recall Classifications Recall Process Identify and Evaluate Decision to Recall Notification Execution Documentation Effectiveness Check Closeout Recall Committee Members and Roles Read also: Resource Person: Alaaeldin…
Airflow Visualization (Smoke Studies) Purpose: Confirms airflow patterns, particularly in cleanrooms and critical areas where contamination control is crucial. Process: Smoke or fog is introduced to visualize the airflow direction, ensuring it moves as intended (e.g., from high to low classification areas) and does not lead to recirculation or contamination risks. Focus Areas: Laminar flow…
A robust Documentation Management System is critical for regulatory compliance, data integrity, and operational efficiency in the pharmaceutical industry. Regulatory Frameworks Governing Documentation Management: Standardization and Control: Clear Accountability: Ensuring Compliance and Adherence to Data Integrity Principles (ALCOA++): End-to-End Document Lifecycle: Ongoing Training: Evaluate & Improve: By controlling templates, maintaining data integrity, and properly managing…
Regulatory Requirements Adhering to FDA and EU GMP mandate robust complaint management process and reporting of serious quality defects Types of Market Complaint Classification of Market Complaint 1. Critical Market Complaint Complaints that pose a serious threat to patient safety or regulatory compliance. Example: 2. Major Market Complaint Complaints that could affect product efficacy or…
