EUGMP Annex 1 was first published in 1971 and the current version came into operation on 2009 (11 years ago) but, since then, several changes occurred. This year, a new EUGMP Annex 1 draft has been issued with significant changes. so How should we interpret and apply it? What are the changes introduced?
The new Annex 1 includes all comments received from more than 140 companies and organizations, so … which are the key changes implemented on the last updates?
Basically, a fundamental revision was made in 2017 and 2020, based on 4 pillars: Organization, Clarity, addition of state-of-the-art principles and implementation of the Contamination Control Strategy (CCS).
Going into detail… what are the main differences between the previous version (current) and the new draft, in terms of structure and contents?
The new draft, compared with the version issued in 2009, current today, is structured in 11 sections, increasing the detail of the requirements. The tittle is also different: ’Manufacture of Sterile Products’ since it applies to the sterile manufacturing processes and their control (both on several product types and packed sizes, such as active substances, sterile excipients, primary packaging materials and finished dosage forms).
Besides, it contains detailed information regarding the use of technologies like Restricted Access Barriers Systems (RABS), Isolators, Rapid Microbial Testing and Monitoring Systems, specific production and sterilization techniques, and it provides a general overview of the requirements concerning the implementation and follow up of an adequate Quality Risk Management and Contamination Control Strategy, throughout the entire processes.
Contamination Control Strategy (CCS), what is expected?
Contamination control strategy (CCS) is one of the key topics introduced in the new draft of Annex 1. Premises and equipment, personnel, raw and packaging materials, utilities maintenance, cleaning and disinfection activities are some of the elements that must be considered during the development of this strategy.
A CCS policy must be available, providing a general overview of the implemented strategy, establishing the main responsibilities for the different departments involved, as well as the methodology to collect data from the monitoring systems and the tools that will be used to evaluate these data. Unexpected results must be investigated, identifying their root-cause and conveying suitable corrective and preventive actions. All this information leads to a continuous improvement of the manufacturing process, the control methods and the Quality System of the company. Quality Risk Management provides a suitable tool to identify and evaluate potential contamination risks to the product, define critical control points and the most appropriate monitoring systems. Component-level risk assessment can be very useful to determine the overall contamination risks.