S
snoopy2017
Hi,
Until a few months ago, a company had contracted out their manufacturing to a CMO (contract manufacturer organization). Since then, they have been slowly bringing the manufacturing process in-house. However, all of their SOPs including their Quality Manual and forms heavily reference the CMO. For a few years, the CMO was heavily integrated into their Quality Management System.
My question is whether or not the reference to the ex-CMO in the company's procedures and Quality Manual will constitute a major finding. The audit is in a few weeks. The company has developed its own manufacturing SOPs in the last two months, but they have not edited out the reference to the ex-CMO in either the Quality Manual or their other procedures.
Any response is appreciated. Thank you!
Until a few months ago, a company had contracted out their manufacturing to a CMO (contract manufacturer organization). Since then, they have been slowly bringing the manufacturing process in-house. However, all of their SOPs including their Quality Manual and forms heavily reference the CMO. For a few years, the CMO was heavily integrated into their Quality Management System.
My question is whether or not the reference to the ex-CMO in the company's procedures and Quality Manual will constitute a major finding. The audit is in a few weeks. The company has developed its own manufacturing SOPs in the last two months, but they have not edited out the reference to the ex-CMO in either the Quality Manual or their other procedures.
Any response is appreciated. Thank you!