A
We are an FDA regulated and ISO 13485 certified medical device manufacturer. During our production of a new lot , there are many inprocess tests and associated records ( a new lot may take up to 6 months to build and 100's of rxns). these highly technical inprocess test data/quality records are reviewed and approved by independant subject matter experts. They are not forwarded to QA for final review. They are maintained within the department. Traceability of the inprocess activities is maintained.
Upon completion, specific key designated Quality Records demonstrating final production quality, material usage, and technical approvals are provided to QA for the final batch review and release.
Are we at risk for compliance issues (GMP, ISO13485) if we do not have QA ownership and oversight on all of the inprocess quality records as well ?
thank you
Upon completion, specific key designated Quality Records demonstrating final production quality, material usage, and technical approvals are provided to QA for the final batch review and release.
Are we at risk for compliance issues (GMP, ISO13485) if we do not have QA ownership and oversight on all of the inprocess quality records as well ?
thank you
