Peak Tailing in Chromatography: Troubleshooting Basics
Explore the essentials of troubleshooting peak tailing, including pro tips, and suggestions for accurate and reliable chromatography.
Defining Specification Limits for Impurities in New Drug Products
Learn how pharmaceutical manufacturers define specification limits for known, unknown, and total impurities in new drug products, ensuring safety and quality compliance with ICH Q3B (R2) guidelines.
User Requirement Specification: How to Create URS for Successful Equipment Procurement
Explore the essentials of User Requirement Specification (URS) for successful project execution. Learn to craft effective URS documents.
Impurities in Pharmaceuticals: Types, Regulations and Strategies
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…
Good Documentation Practice: Ensuring Data Integrity and Compliance in the Pharmaceutical Industry
Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability.
GMP Cleanroom Classifications: Understand Class A, B, C and D
Learn GMP cleanroom classes A, B, C, D for contamination control in pharmaceuticals. Understand air cleanliness & particle counts for compliance.
Electronic Quality Management Systems – eQMS
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.
FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products
Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for eye care innovations.
GMP Regulatory Bodies: Understanding the Key Differences
Explore global GMP standards with regulatory bodies like FDA, EMA, and WHO. Ensure compliance for pharmaceutical quality and safety worldwide.