Scope
This new Focus Group was formed in 2014 to bridge the gap between the science and regulation of medicines, and to facilitate discussion and consideration of regulatory aspects relevant to the development of new and improved medicines. There is considerable overlap between the specialist scientific areas covered by existing APS Focus Groups and the key operations for which the MHRA has regulatory responsibility. The Regulatory Focus Group will aim to bring a new dimension to the work of the existing Focus Groups by way of a support network and through collaborative work. In addition, the Regulatory Focus Group will develop and deliver its own agenda for the benefit of APS members. If this is of interest to you, then you are invited to join this Focus Group.
Aims and objectives:
The main aims of this focus group are:
- To provide a forum for discussion of regulatory issues that are of
interest to the APS membership - To facilitate discussion on new product development approaches, manufacturing technologies or drug delivery approaches that have a regulatory impact
- To promote pharmaceutical science and innovation
- To provide training and education on regulatory topics for the benefit
of members - To provide a collaborative network of subject matter experts able to respond to new regulations.
Steering Committee
The Steering Committee members are:
- Dawn Adkin, CMC Consultant
- Alastair Coupe, Pfizer
- Malcolm Dash, MHRA (Chair)
- Begoña Delgado-Charro, University of Bath
- Elspeth Gray, MHRA
- Roy Jamieson, AstraZeneca
- Matt Popkin, GSK
- Colm Reddington, MHRA
- Steve Robinson, Drugs for Neglected Diseases initiative
- Walkiria Schlindwein, De Montfort University, Leicester
The first meeting of the Steering Committee took place on 3rd October 2014.
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NEW 29 January 2015
The next meeting of the Steering Committee will be held on 06 February 2015 when the Committee will be finalising their proposals for their contribution to the APS PharmSci 2015 Conference - further information to follow.
The Steering Committee will also be taking forward ideas from previous discussion on Hot TopicsI and beginning work leading to 1-2 day meetings later in 2015 and in 2016 and looking at potential colloborations with other Focus Groups - watch this space.
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The Regulatory Focus Group presented a session at PharmSci 2014 under the title: process validation and continuous process verification - expectations and experiences
The session was well-attended with 60-70 delegates at each of the excellent presentations. The three invited speakers described the requirements for the discussion of process validation in a marketing authorisation application; how to investigate, identify and control the critical aspects of a manufaturing process; and the findings and experiences gained from inspection of manufacturing sites.
Dr Catherine McHugh (PAREXEL Consulting) described the changes that have been made to the European dossier requirements for process validation as detailed in the revised European guideline that came into effect on 27th August 2014. The title of the revised guidance has ben amended to reflect the dossier requirements and to move away from GMP aspects that are covered in Annex 15 of the EU GMP requirements. The guideline also now covers continuous process verification.
Penny Butterell (Pfizer) desribed an approach to implementing a lifecycle approach to process validation. Her key messages were that a science and risk-based control strategy is a key concept in Quality by Design, that can bring increased assurance of product quality. It is important that the control strategy covers all relevant aspects of the quality system and that the extent and scope of process validation that follows should be driven by the control strategy and level of process understanding. Successful process validation can therefore verify that a control strategy is suitable for commercial manufacture, but it must be subject to continuous improvement.
The final speaker, Des Makohon (MHRA), gave A GMP inspector's view on successful validation practice. He raised the issue of variability in manufacturing processes and the need for increased process and product understanding to identify and manage the critical sources of variability. His key message was that the industry needs to invest in pharmaceutical development to identify critical material and process parameters that affect product quality. He advocated the use of risk management tools, the use of design of experiments, and multivariate analysis. He also highlighted the need to design control systems with appropriate measurement capability to allow feedback and adjustment of critical quality attributes.
If you are interested in joining the Regulatory Focus Group or if you have suggestions for topics which you would like the Steering Committee to consider, please contact Malcolm Dash at [email protected]
