Tag: Regulatory compliance

In July 2012, new EU pharmacovigilance legislation was implemented, triggering the replacement of EudraLex Volume 9A with the comprehensive Good Pharmacovigilance Practices (GVP) guidelines. This significant shift in medication safety and pharmacovigilance marked an evolution in regulatory standards for the pharmaceutical industry across Europe.

Regulatory violations related to data integrity have prompted stricter oversight from bodies like the FDA and EMA. This has elevated the importance of data integrity principles, leading to the evolution from ALCOA to the more comprehensive **ALCOA++**. This advanced framework ensures that data generated throughout the pharmaceutical lifecycle is reliable, secure, and fully traceable, protecting patient safety and enabling regulatory compliance.

With members from over 160 countries, the International Organization for Standardization (ISO) develops and publishes globally recognized standards. In the highly regulated world of pharmaceuticals, understanding **what does ISO stand for in pharma?** is crucial for ensuring the quality, safety, and efficiency of products that ultimately reach patients. While its primary meaning relates to quality standards, the term 'iso' has also emerged in a completely different context as a street drug.

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.

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.

The global pharmaceutical ERP market is projected to reach billions, signaling its importance in modern healthcare operations. So, **what is ERP in pharmacy** and why is this technology so critical for managing complex inventory, ensuring regulatory compliance, and ultimately enhancing patient safety and care?

The global pharmaceutical ERP market is projected to reach $3.71 billion by 2027. A key driver of this growth is SAP (Systems, Applications, and Products), an enterprise resource planning (ERP) software that streamlines and integrates core business processes. So, **what is SAP in pharmacy?** It's the digital backbone for managing operations.