The traceability of pharmaceutical manufacturing processes is critical to navigating the complexity of government regulations that impact the design, development, production and distribution of medications. The recent introduction of the EudraLex Volume 4 Annex 1 guidance regarding the manufacturing of sterile medicinal products is an example of good manufacturing practices (GMPs) that help ensure quality and safety. But the challenge comes with documenting the process, as Roberto Zerbi, Global Life Sciences Business Development Manager at industrial technology manufacturer Watlow, explains.
The EudraLex Volume 4 Annex 1 guidance, which comes into effect in August 2023, illustrates how new regulations are introduced to grow trust in the life sciences business.