Early Phase GxP Compliance
Aptiv Solutions understands that compliance with applicable regulations and guidance throughout the product life cycle from Phase I to post-marketing approval is essential to achieve pharmaceutical development goals. The Early Phase GxP Compliance group works side-by-side with the technical experts in Preclinical, CMC and Clinical Development to ensure appropriate application of key elements of GLP, GMP and GCP along the development pathway. The approach for providing compliance support is tailored to the needs of each client and varies from development of a self-contained, project-specific Project Quality Plan to providing specific quality services such as supplier quali-fication and auditing as specified in a Technical (Quality) Agreement agreed with a client.
GxP Compliance Process
The emphasis of the Compliance team is on provision of proactive services which include supplier evaluation, risk assessment of process and system change strategies, development of quality systems, site readiness prior to regulatory inspections, and co-development of Pre-Approval Inspection (PAI) readiness strategies with Preclinical and CMC team members. The Compliance team also stands ready to serve on an emer-gency basis to assist clients with development of corrective actions in response to deficiencies identified by regulatory agencies. This service includes assistance with resolution of “483” observations and Warning Letter citations issued by the US FDA.
