We are virtual manufacture, legal manufacturer. Design, manufacturing, distribution, etc. are externalized. We only have 1 product but with many parts.
1) we currently initiate 1 ECO for every change notice (for DWG, WI, LHR, test protocols, etc.) the CMO sends us. Mainly to assess the risk and if we need to advise the NB. There are a lot of notices. How can we simplify this process? Are you using a scale (critical, not critical)?
2) we currently have SOPs for production/ design/ process validation/ statistical analysis/ work environment/ infrastructure/ etc. even if we don't do those activities (they are externalized). Could we simply refer to our CMO procedures into either the Quality manual or a quality plan?
How do you manage those 2 items?
Thanks in advance,
Romane
1) we currently initiate 1 ECO for every change notice (for DWG, WI, LHR, test protocols, etc.) the CMO sends us. Mainly to assess the risk and if we need to advise the NB. There are a lot of notices. How can we simplify this process? Are you using a scale (critical, not critical)?
2) we currently have SOPs for production/ design/ process validation/ statistical analysis/ work environment/ infrastructure/ etc. even if we don't do those activities (they are externalized). Could we simply refer to our CMO procedures into either the Quality manual or a quality plan?
How do you manage those 2 items?
Thanks in advance,
Romane