Tag: Pharma

According to the World Economic Forum, by 2025, artificial intelligence (AI) is estimated to drive 30% of new drug discoveries, highlighting its pivotal role in reshaping the pharmaceutical landscape. In response to technological innovation and evolving patient needs, understanding what are the trends in pharma industry 2025 is essential for navigating this transformative era.

First approved by the FDA in 2014 for treating metastatic melanoma, the cancer immunotherapy drug Keytruda is one of the world's best-selling medicines. For patients and healthcare professionals, understanding which pharma company makes KEYTRUDA is important for tracing its origins and development. The answer is the pharmaceutical giant Merck & Co., Inc., also known as MSD outside the United States and Canada.

According to the EU GMP Guide Part I, a CoA provides an overview of test results for a product batch. **What is CoA in pharma?** It's a formal document issued during drug manufacturing and development to confirm that a specific batch of a product meets its pre-established quality specifications.

Regulatory bodies like the FDA consistently cite inadequate Corrective and Preventive Action (CAPA) processes as a leading cause of enforcement actions. So, **what is capa in pharma**? It is the bedrock of quality management, a structured, systematic process for investigating and resolving quality issues while preventing their recurrence.

The pharmaceutical industry's reliance on computerized systems has grown exponentially, making a robust Computer System Validation (CSV) process more critical than ever before to ensure product quality and patient safety. This documented process proves that all software and hardware perform as intended throughout their entire lifecycle.