EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging

The pharmaceutical industry is constantly seeking innovative solutions to improve aseptic manufacturing and maintain strict quality standards. The recent revision to Annex 1 of the Good Manufacturing Practices Guide has presented new challenges for pharmaceutical manufacturers in implementing contamination control and sterility assurance strategies. Compliance with the new Annex 1 is crucial, as it emphasizes the importance of the Pharmaceutical Quality System, Quality Risk Management, and Contamination Control Strategy in ensuring the production of sterile medicines.

To meet these requirements, manufacturers may need to invest in new technologies and update their premises and equipment. Ready-to-use packaging is one such technology that simplifies the filling process and eliminates the need for multiple preparation phases. However, there are discrepancies between the pharmaceutical and packaging industries in implementing these guidelines.

The packaging industry plays a fundamental role in ensuring the quality of finished products. The EU GMP standard for primary pharmaceutical packaging is ISO 15378:2017, which integrates GMP requirements specific to ISO 9001. By using sterile containers produced by ISO 15378-certified companies, pharmaceutical manufacturers can benefit from reduced contamination and production errors, increased efficiency, compliance with regulatory requirements, and improved processes.

Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and reduces costs by outsourcing non-core activities can help prevent contamination, reduces the effort and liability of the Container Closure System, and reduce activities compared to standard packaging.