The ICH has published a question and answer (Q&A) document to clarify some of the common issues encountered by pharma companies implementing Q8, Q9 and Q10 guidelines.
In the Q&A document are commonly questions asked by companies implementing the guidelines on Pharmaceutical Development (Q8), Quality Risk management (Q9) and Pharmaceutical Quality System (Q10).
These were developed by the International Conference on Harmonisation (ICH) in an attempt to create a risk and science-based approach to quality and encourage continuous improvement.
The ICH said: “As these concepts and principles are rather new in the pharmaceutical area, it is important that, due primarily to departure from the traditional approaches to quality guidance, proper implementation of these concepts is provided by bringing clarity, further explanation and removing ambiguities and uncertainties.”
One aspect the ICH is keen to clarify it has not endorsed products labeled as “ICH compliant solutions”, “ICH Q8, Q9 & Q10 implementation software”, etc and these are not required to implement the guidelines.
The ICH acknowledges that similar software will continue to proliferate but has no plans to endorse any and recommends companies “carry out their own evaluation of these products relative to their business needs”.
Q10 and GMP inspections
Also covered in the document are questions tackling Q10, its impact on good manufacturing practice (GMP) inspection practices and how the guidelines relate to knowledge management.
In particular the Q&A asks “how will product-related inspections differ in an ICH Q8, Q9 and Q10 environment?” The ICH believes that these will require a greater deal of cooperation between investigators and assessors if the facility is operating under the Q guidelines.