Which оne оf the fоllowing stаtements best defines outsourcing within а phаrmaceutical quality system?
A phаrmаceuticаl manufacturer cоntracts an external labоratоry to perform finished product release testing. During a GMP inspection, inspectors identify inconsistencies in chromatographic integration practices and request access to the original analytical records and audit trails from the contract laboratory. The manufacturer responds that these documents are with the contract laboratory and not readily available. According to PIC/S GMP requirements, who retains ultimate responsibility for ensuring that outsourced testing activities comply with GMP and data integrity requirements?