Mastering CGMP Compliance: The Power of Risk Management in the Pharmaceutical Industry

Maintaining CGMP compliance is critical for patient safety and product quality, yet many organizations face challenges in effective risk management, leading to regulatory issues. This article examines the root causes of CGMP failures, stakeholder dynamics (CDMOs, suppliers, sponsors), and offers strategies to enhance risk management and foster a culture of proactive compliance.

The Role of the Quality Unit in Pharmaceutical Manufacturing: Ensuring Compliance and Product Quality

The pharmaceutical Quality Unit plays a vital role in ensuring CGMP compliance and product quality. This article explores the key responsibilities of the Quality Unit, including establishing quality systems, auditing compliance, and conducting laboratory tests. It also discusses the challenges faced by Quality Units, such as managing third-party contracts and meeting regulatory requirements. Learn best practices to enhance the effectiveness of Quality Units and ensure compliance, trust, and credibility in pharmaceutical manufacturing.

Laboratory Data Integrity: Why It Matters and How to Ensure It

Laboratory data integrity is crucial for accurate, reliable, and compliant data management. This article explains the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and offers best practices to maintain data integrity, such as secure systems, staff training, and standardized procedures. It also highlights common errors that compromise data quality and emphasizes the importance of data integrity in meeting regulations and building trust.