The development and release of pharmaceutical products require the use of modern, efficient, and adaptable analytical techniques to assure efficacy and patient safety. The growing interest in complex ...

Prompted by the global challenges brought on by the COVID-19 pandemic, the World Health Organization (WHO) is recommending that all pharmaceutical control labs – whether private or national – should ...

With the publication of ICH Q2(R2) and ICH Q14, the modern Quality by Design (QbD) paradigm introduced by ICH Q8 for manufacturing has now been extended to Quality Control (QC). A life cycle and ...

Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control. Pharmaceutical manufacturing is entering a phase ...

Analytical quality control refers to all those processes and procedures designed to ensure that the results of laboratory analysis are consistent, comparable, accurate and within specified limits.

Researchers engaged in pharma research and development must adhere to current Good Laboratory Practice (cGLP) and Good Manufacturing Practice (cGMP) standard operating procedures. Such regulatory ...

India’s Natco Pharma was hit with a Form 483 by the FDA following an inspection that resulted in eight observations. The citation centered on a lack of cleanliness and sterility of equipment plus ...

Gas analysis is a crucial aspect of pharmaceutical quality control, which plays a significant role in ensuring the safety and efficacy of drugs. This article discusses the role of gas analysis in ...

Residual solvent analysis is a critical component of pharmaceutical quality control, ensuring that trace levels of organic solvents used during synthesis, purification or formulation fall within ...

Are you ready to revolutionize quality control and deviation management? Discover how AI can empower your organization with process automation, workflow visibility, real-time reporting, and analytics ...

Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S. Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the ...