Urgency for authorization/approvals of pandemic vaccines & treatments present the opportunity to reconsider quality inspections.
• Constraints associated with the pandemic have disrupted conventional inspections including delaying approval of products.
• BoHs have apparently adopted a risk-based prioritization approach to determine the need for inspections.
• Several alternatives have emerged, i.e., waivers, postponements, delays, virtual inspection options, etc.
• Industry should leverage the quality maturity of a company’s manufacturing facilities & systems to drive toward adoption of these alternatives as well as Mutual Reliance/Recognition among BOHs.
Tim is the Global Leader of Pfizer’s CMC Advisory Office, a collection of global Pfizer technical and regulatory experts that provide guidance & direction to project teams to mitigate regulatory risk & integrate CMC policy with product strategies; while developing and advocating policy positions (internally and externally) in conjunction with QO. He has been instrumental in development & implementation of Quality by Design, ICHQ12, etc. & continues to advocate for global regulatory harmonization & mutual reliance serving as a PhRMA representative to several ICH Expert & Implementation Working Groups (EWG & IWG) since 2009. Tim served as a PhRMA EWG member on the ICHQ11 regulatory guidance document for drug substance, the Rapporteur for the ICHQ11 Q&A Starting Material IWG, PhRMA IWG member for the ICHQ7 Q&A team and continues to serve as the PhRMA ICHQ3C EWG lead. Recently, Tim has been nominated to serve as the PhRMA IWG/ EWG lead for ICHQ9 revision (starting in 2020).