Hello everyone,
DHRs are production records, but are they ever inspected by FDA or audited by a notified body? In the companies I've worked at, the DHR is a replica of the DMR except it the boxes for dating and initialing next to the manufacturing steps. So if the auditor reviews the production records (e.g. the DHR), doesn't that defeat the purpose of a DMR index because in reviewing the production records, they would see the entire manufacturing process anyway? The point of producing a DMR Index is so that you would not have to provide proprietary information during the audit. But if they have to looking at the manufacturing records, are we not also disclosing the manufacturing steps? I am looking for clarification. Any insight into this, I would appreciate it.
Thank you.
DHRs are production records, but are they ever inspected by FDA or audited by a notified body? In the companies I've worked at, the DHR is a replica of the DMR except it the boxes for dating and initialing next to the manufacturing steps. So if the auditor reviews the production records (e.g. the DHR), doesn't that defeat the purpose of a DMR index because in reviewing the production records, they would see the entire manufacturing process anyway? The point of producing a DMR Index is so that you would not have to provide proprietary information during the audit. But if they have to looking at the manufacturing records, are we not also disclosing the manufacturing steps? I am looking for clarification. Any insight into this, I would appreciate it.
Thank you.