Origami Out of Scope for Pharmaceutical
Pharmaceutical companies selling to the US, need to comply with FDA Laboratory testing CGMP regulations (§§ 211.160 and 211.165) in order to ensure conformance to specification.
Manage Out of Specification (OOS) results. When your company sends products to the laboratory to be tested, it’s possible that an out of specification (OOS) test result is returned. Origami lets your Quality Control Unit (QCU) log the OOS test result, and attach laboratory test data, findings and supporting documentation to the investigation
Determine Aberration Cause. Document the conclusion as to whether or not the aberration was caused by the lab’s analytical method or instrumentation failure. End the investigation if the cause was the laboratory, or complete a full investigation if the cause was due to manufacturing.
If there was no lab error your team follows the full investigation procedure that is stored in the Origami Document Control Software. Your team reviews production and sampling procedures, and performs additional laboratory testing in order to determine root cause. Origami lets your team capture the investigation reason, manufacturing processes that may have caused the problem, documentation review results, review of previous problems, and corrective actions.
Origami automates involving different teams in the root cause determination through email invitations, reminders, and our collaboration tool.
Simultaneously your QCU determines potential impact on any already distributed batches of your products. Successful root cause determinations may lead to rejection or reprocessing of batches associated with the failure, which are noted in your internal investigation.
Your conduct and complete your investigation within 3 days of receiving an OOS test result so that your company can submit a field alert report (FAR) to the FDA, outlining the failure and potentially impacted batches.