Pharma Talk

To conduct a **gap assessment** between the **old Schedule M** and the **revised Schedule M** of the **Drugs and Cosmetics Rules, 1945**, we...

On June 6, 2025, the U.S. Food and Drug Administration (FDA) sent a stern warning letter to Horizon Tool Inc., a Greensboro, North Carolina-...

Here’s a rewritten and detailed version of the FDA Warning Letter topic for your blog: --- 🧪 “Memory‑Based Manufacturing” and the Critical ...

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to AACE Pharmaceuticals, a U.S.-based company, on April 9, 2025, followi...

In the pharmaceutical industry, maintaining high-quality standards is critical to ensuring safe and effective products. A key component of t...

The company experienced seven out-of-limit (OOL) events for microbial content in a system used to generate a major component of drug product...

The draft guideline "STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS" of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION O...

The FDA found that although there were requirements in the Validation Master Plan for process validation and hold times, no operating condit...

In 2022, the WHO published the "Technical Report Series 1044, 2022" called "TRS 1044 - Annex 4: WHO guidelines on technology ...

Your firm failed to conduct adequate manufacturing investigations into out-of-specification (OOS) results obtained by your external laborato...