Streamlining Change: New EU Guidelines Simplify Medicines Lifecycle Management
EMA welcomes the publication of the European Commission’s (EC) new Variations Guidelines, which streamline the lifecycle management of medicines (see EC news). These EU Variation guidelines will support the implementation of the new Variations Regulation that came into force in 15 January 2025.
What is a Stability Study?
A stability study is the evaluation of the ability of a pharmaceutical product to remain in its quality, safety and efficacy over a period under designated environmental conditions. It is critical in the establishment of shelf life, packaging, and storage rules. The regulatory bodies demand stability data so that medicines can be useful and safe during their required usage.
What is an Audit Trail?
The accuracy, integrity and traceability of data is non-negotiable in the pharmaceutical industry. All data created in the process of drug development, manufacturing, testing, and distribution should be dependable and inaccessible.
Changes to e-Submission Requirements for CEP Applications
As part of continuous digital transformation in regulatory processes, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has introduced automation to enhance the management and review of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) submissions.
What is Batch Record Review?
Product quality and regulation standards are of paramount importance in the pharmaceutical manufacturing process. The Batch Record Review (BRR) is one of the most vital aspects that guarantee this compliance. It is a documented verification procedure that either validates or disapproves a drug product upon release that has been produced using Good Manufacturing Practices (GMP), approved procedures and regulatory compliance.
