Annex 1 and Contamination Control Strategy

Piero Iamartino

In the current regulatory framework, manufacturers are required to develop a set of control strategies to confirm their process performance and product quality. 

In particular, the new EU GMP Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to comply with these requirements by preventing microorganisms, pyrogens and particulates contamination in sterile medicinal products. Piero Iamartino, pharmaceutical consultant and EIPG Technical and Professional Development Vice President, joined Making Connect for an interview focused on Annex 1 and CCS. In this conversation, he also introduced the EIPG initiatives in support of its associates.