Tag: Gcp

According to the FDA, data integrity violations are consistently among the top reasons for regulatory actions such as warning letters and product recalls. For this reason, the global benchmark for data integrity is the framework known as ALCOA+, a set of principles that ensures trustworthy and reliable data throughout the life sciences and pharmaceutical sectors.

Established in the early 1990s to harmonize pharmaceutical oversight, EudraLex is the official compilation of rules governing medicinal products within the European Union (EU). This extensive collection of legislation and guidelines is mandatory for any company seeking market access in the EU pharmaceutical ecosystem, ensuring products meet stringent safety, efficacy, and quality standards.

Regulatory bodies like the FDA issue hundreds of warning letters annually for non-compliance, with significant financial penalties. Understanding **what GxP in pharma is** becomes crucial, as it represents the set of guidelines that ensures pharmaceutical products are safe and effective.