Annex 1 Updates

11 May 2018

In December 2017, the European Commission produced a draft copy of the Annex 1 updates. The Annex is written with the purpose of emphasising the special requirements to be taken when manufacturing products that have a direct influence on a patient’s health. These requirements are set out to minimise the microbiological risks amongst those other risks that have come to light with the emergence of new technologies, inadequate root case analysis, ineffective CAPA and poor implementation of ICHQ9.

The draft copy was made available for public comment, and Microgenetics attended/participated in several of these public consultations, including those provided by Pharmig and PHSS. It is exciting to be part of a time where guidance can be influenced to ensure the minimisation of the risk of microbiological contamination while at the same time playing an active role in revolutionising methodologies to provide greater patient safety.

The uses of rapid methods are mentioned for the first time in the draft in section 9 for environmental monitoring and section 10 for end-product testing. At this time, further detail has yet to be provided, however with the global approach to the writing of this draft (FDA participation in review at the PICS convention), it is assumed that use of references such as the PDA TR33 and the USP Ch 1223 is the go-to guide for validating and implementing the use of these tests within the pharmaceutical setting. The reference to rapid microbiological methods at least paves the way for considering alternatives like the Microgenetics SwiftDetect. The Annex emphasises that these methods should be considered only after validation and “as long as they are demonstrated to be at least equivalent to the established methodology”. Microgenetics SwiftDetect has been designed with the highest sensitivity level as we understand the risk to patients of introducing a single unwanted contaminant and our validation is designed to meet these prescribed guidance criteria, making the onsite implementation and validation of the test straightforward for our customers.

Along with the reference to rapid methods, the many references to the use of quality risk management approaches is notable, SmartControl has been designed to ensure that the capture of environmental monitoring data is reliable and robust while at the same time easy to perform and meets the necessary data integrity requirements laid out by the regulators. No data integrity updates have been provided at this stage, but it is believed this is due to the many difference guidance documents readily available that cover the data integrity requirement as well as cross-references to other Annexes which provide this guidance.

Microgenetics is confident its products actively support companies in meeting the guidelines laid out in both in their current format, and it’s soon to be updated form. If you have any questions as to how we may better support you in meeting any of the changes raised in the recent draft document or your approach to cGMP, please contact us.