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 ...

Nitrosamines are a class of compounds that can form when amines react with nitrosating agents under favorable conditions.

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 ...

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 ...

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 ...

Continuous human oversight across design, validation, and operational deployment is positioned as the primary control to balance AI capability with GxP risk management. Investigation effectiveness can ...

At a time when the pharmaceutical industry is navigating increasing regulatory scrutiny, rapid digitalization, and growing expectations around trust and transparency, the conversation around quality ...

Analytical tasks in the pharmaceutical industry range from drug discovery to production and quality control for consumer product. This entire process is subject to a variety of laws and regulations ...

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 ...

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 ...

When a patient picks up a prescription from a pharmacy, there’s an expectation it will be safe and effective, given the strict regulation around drug approvals. That’s why managing the entire supply ...

Environmental contamination control is a crucial aspect of sterile pharmaceutical manufacturing, and risk management is needed to guarantee that the necessary control procedures are in place. The risk ...