The revision to Annex 1 to the Good Manufacturing Practices guide by the European Medicines Agency introduces new challenges for pharmaceutical manufacturers implementing contamination control and sterility assurance strategies.
Anyone who wants to produce sterile medicinal products to be marketed on the European territory must provide complete documentation that allows regulatory authorities to verify the robustness and reliability of the measures taken to comply with GMP.
The packaging industry has already responded to the market’s needs by proposing updated solutions that comply with the latest standards and requirements. The offer of sterile and ready-to-use packaging can represent a possible solution to reduce execution times and costs.
Stevanato Group‘s EZ-fill® pre-sterilized platform can aid compliance with EU GMP Annex 1 as it is a fully integrated pre-sterilized containment solution for aseptic manufacturing that meets the strictest of requirements for contamination control, as outlined in the strategy of Annex 1. Total costs are reduced by relying on experienced external partners for non-core activities.