Qualified Persons will have new legal duties when managing decentralised manufacturing and testing. In this clip, Dr. Peter Gough explains that QPs will be responsible for supervising decentralised activities, conducting regular audits, carrying out periodic on-site visits, confirming GMP compliance to regulatory authorities and notifying changes that may affect quality or safety.
This is a high-priority update for QPs, quality assurance leaders and pharmaceutical manufacturing organisations because decentralised manufacturing increases the importance of documented oversight, audit readiness and clear accountability between central sites and remote sites. Understanding these duties early can help companies plan governance, resourcing, audit schedules and regulatory communications before requirements become operational pressure.
Stay current with pharmaceutical legislation, GMP guidance and regulatory authority updates through NSF’s Pharmaceutical Legislation Update Subscription Service. The subscription provides 12 months of updates on changes to legislation and guidance that may impact the manufacture and distribution of medicinal/drug products, with recorded updates available through NSF’s online LMS and quarterly live Q&A sessions with Dr. Peter Gough. The service is also approved by the Royal Society of Chemistry as suitable for CPD.
