D
Dr RA
Hi All
A document that has not been approved was available in the production drive. The production has not used the document, but had access to the unapproved document. This manufacturing requires validation due to formulation change and has not been validated and approved yet. Production has enquired about this unapproved document and if this can be used as the current version(approved) has been removed from manufacturing access and also attached this document(unapproved) in electronic format..
Due to recent developments on electronic management system, the SOP does not mention of the electronic access to the documents and at the same time does not mention of the copies only available as hard copy. It clearly mentions the current version of documents will be approved and distributed and a master copy will be retained.
A NC has been raised on clause 4.
Do you agree this a non conformance - if yes under what basis?
A document that has not been approved was available in the production drive. The production has not used the document, but had access to the unapproved document. This manufacturing requires validation due to formulation change and has not been validated and approved yet. Production has enquired about this unapproved document and if this can be used as the current version(approved) has been removed from manufacturing access and also attached this document(unapproved) in electronic format..
Due to recent developments on electronic management system, the SOP does not mention of the electronic access to the documents and at the same time does not mention of the copies only available as hard copy. It clearly mentions the current version of documents will be approved and distributed and a master copy will be retained.
A NC has been raised on clause 4.
Do you agree this a non conformance - if yes under what basis?
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