GMP Insiders

Discover the essentials of cold chain management in pharma to ensure the safety and efficacy of temperature-sensitive products like vaccines and biologics.

Airflow Visualization Smoke Studies (AVS) ensure cleanroom compliance by visualizing airflow patterns to detect turbulence and verify unidirectional flow, critical for aseptic environments.

Learn the essential steps for supplier qualification, ensuring that suppliers meet GMP standards, mitigates risks, and maintains quality in the pharmaceutical industry.

Learn more about Batch Manufacturing Records (BMR), essential for consistent, safe pharmaceutical production and compliance with regulatory standards.

Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy.

Explore essential strategies for mitigating risks in temperature-controlled environments, ensuring product stability and safety in pharmaceutical storage.

Explore the crucial role of pharmacovigilance in ensuring medication safety, from detecting adverse effects to proactive risk management.

Explore the crucial roles of Design Review and Design Qualification in the pharmaceutical industry, ensuring equipment meets user needs and complies with rigorous standards.

Explore best practices in environmental monitoring for pharmaceutical cleanrooms, ensuring sterility and safety with comprehensive guidelines and tips.

Explore the essentials of Quality Risk Management in Pharma: Principles, tools, guidelines, and implementation strategies for enhanced safety.

Explore the essentials of User Requirement Specification (URS) for successful project execution. Learn to craft effective URS documents.

Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements, testing strategies, and the importance of analytical methods in ensuring…

Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability.

Learn GMP cleanroom classes A, B, C, D for contamination control in pharmaceuticals. Understand air cleanliness & particle counts for compliance.

Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence, and elevate overall product quality.

Navigate success in the pharmaceutical industry with GxP compliance. Explore GMP, GLP, GDP, and GCP for quality, safety, and regulatory excellence

FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release, process validation, and stability testing. Explore the corrective actions and…

Explore key sampling methods in environmental monitoring, like air, surface, and personnel sampling, to ensure GMP compliance and maintain cleanroom product safety.

Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria.

Learn about the granulation process in pharmaceutical manufacturing, its types, equipment, and role in improving flowability, compressibility, and product quality

FDA's 2024 guidance on nitrosamine impurities introduces new limits, testing methods, and timelines, focusing on NDSRIs to enhance drug safety and compliance.

Discover the key differences between RP-HPLC and NP-HPLC. Learn how these contrasting chromatography techniques drive effective compound separation and analysis for diverse applications.

Learn how to create a comprehensive Validation Master Plan (VMP) to ensure consistent product quality and regulatory compliance

Discover the best practices for establishing and managing expiry dates for commercial and in-house prepared reagents in QC labs.

FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and steps for compliance.

Explore the different types of GMP documentation in the pharmaceutical industry, essential for maintaining quality, compliance, and safety in manufacturing processes.