Regulatory Update: EMA Presentation, EU Regulator Training

Members Represent ISPE at Prestigious EMA Events Presentation to EMA on Drug Shortages ISPE was among a limited number of organizations invited to an invitation-only EMA workshop in October intended to increase awareness and investigate the possible causes of shortages in the supply chain. The workshop involved discussion with patient and patient supply groups as well as technical representatives from industry.  ISPE’s Drug Shortages Team members provided input from the ISPE Drug Shortage survey conducted earlier this year.

ISPE plans a series of Drug Shortage session in 2014. Presentation to EMA on Dedicated Facilities In September, ISPE was represented at an invitation-only workshop with members of the Quality Working Party (QWP), Safety Working Party (SWP) and Inspectors’ Working Party to discuss responses to the SWP draft guideline on setting health-based limits for shared facilities and the updates to Chapters 3 and 5 of the EU GMPs.  Stephanie Wilkins, PE, (PharmaConsult US), former member of the ISPE International Board and co-Chair of the ISPE Risk-MaPP Baseline Guide Task Team, and ISPE Regulatory Advisor John Berridge, PhD, provided a presentation based on earlier ISPE comments.

ISPE provided input to a proposed submission drafted by EFPIA.  The EMA expects to issue a further draft during the first half of 2014. Presentation to EMA on Process Validation Earlier in 2013, Steve Tyler (AbbVie), former member of the International Board and current Chairman of the PQLI Steering Committee, represented ISPE at an invitation-only EMA break out session with members of the QWP on the revision of the process validation guideline. The break out session was held to discuss written stakeholder proposals on questions put forth by the QWP on continuous process verification, continued (ongoing) process verification, design space verification and non-standard manufacturing processes.  ISPE joined other interested parties representative of a cross section of the European pharmaceutical sector. The ISPE responses to the QWP questions reflected industry experiential learning captured through the PQLI Technical Committee members. ISPE Members Deliver Training to EU Regulators on QbD, QRM.

The second ISPE-organized training event took place in October for more than 30 European GMP inspectors. The first training event, also on QRM, took place in June with approximately 15 GDP inspectors participating. Attendees included MHRA inspectors as well as inspectors from other regulatory agencies, including the Irish Medicines Board. The ISPE group organizing and presenting the training is being led by Chris Potter, a member of ISPE’s PQLI team. Each of the single-day programs included a review of the different QRM tools used by industry and a discussion about how QRM might be used by in relation to proposed changes in Annex 16 of the EU GMP Guide. The GDP QRM event also looked at the impact of the introduction of QRM into the EU GDP Guidelines. Following on the positive feedback from the regulators in attendance, a two-day training for an additional 30-plus inspectors and assessors is scheduled for February 2014. This event will look in depth at the application of QbD as well as touching on QRM and ICH Q10.