Pharmaceutical wholesalers rely more and more on advanced IT systems for the storage, management and distribution of medicinal products. The introduction of information technology in the pharmaceutical industry has brought many benefits, but at the same time imposes responsibility for ensuring the security, effectiveness and compliance with regulations of these systems.
Pharmaceutical supply chains are inextricably linked to Good Distribution Practices, Good Manufacturing Practices, and the Code of Federal Regulation; these regulations and guidelines ensure that pharmaceutical products are distributed according to appropriate standards and with safety. One of the key elements of ensuring safety and quality in pharmaceutical wholesalers is process validation.
Annex 1, “Manufacture of sterile medicinal products,” is part of EudraLex Volume 4, which provides guidance on the minimum control measures required to protect sterile medicinal products during manufacture. All manufacturers supplying medicinal products to the European market must comply with these requirements to minimize the risk of microbiological, particulate and pyrogenic contamination of the final product.
We provide comprehensive and goal-oriented quality services for companies in regulated industries and beyond. We handle everything from step one and deliver more than you expect. On time.
Contact
Main office:
Aleje Jerozolimskie 195B
02-222 Warszawa
Wrocław office:
ul. Piłsudskiego 13
50-048 Wrocław
ecvalidation is a team of experts specializing in validation and qualification services of software, equipment, installations, rooms and processes.