In the pharmaceutical industry, regulatory authority inspections are not just a formality—they are a critical safeguard to ensure that products are manufactured, tested, and distributed in a safe, effective, and compliant manner. However, effective inspection readiness goes beyond documentatio…

One common misconception we notice in various parts of the world is that marketing offices are exempt from GDP compliance because they don’t PHYSICALLY handle, store, or distribute medical products. This is a dangerous oversimplification because your marketing office influences WHO distributes…

In comparison with the Federal Decree-Law n8 of 2019, distribution reporting is being reinforced, with notable expansions of scopes, responsibilities and introduction of strict timelines. A national database for reporting counterfeit has been also introduced in an effort to fight such illegal…

The purpose of computer system validation (CSV) is to guarantee confidence in the data captured, processed, reported or stored on computerised systems. A validated system ensures accurate results and reduces any risks to data integrity. The extent of validation activities should be defined bas…