IPEC e-newsletter - Excipients Insight December 2017 - 18-12-17


Inside this issue


ICH Q3D taskforce looks ahead to first inspections in 2018

The IPEC ICH Q3D Task Force has had a busy year, focusing its attention on monitoring the implementation of the guidelines and the efforts of pharmaceutical manufacturers  to ensure their existing products are in alignment with the new requirements. From an objective standpoint, the impression has been that the compliance process has gone rather smoothly - assessments reveal no products failed compliance tests and in just a few cases control strategies had to be implemented for new products.

The Task Force would like to hear from excipient manufacturers as they pass the one-year timeframe from the start of the new requirements, and this will be one topic of discussion in a teleconference scheduled to be held on 18 December, ahead of the festive break.

Looking ahead to 2018, the team anticipates the outcome of the first inspections where the Q3D risk assessments made by companies will likely be a key feature. It will be interesting to see how the detailed risk assessments are viewed by authorities and what if any implementation issues they uncover. Once the outcome of inspections becomes clearer the taskforce will seek to decipher these to determine what if any further materials it may need to  develop to help companies align with inspectors' expectations.




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