Suggestions requested on handling batch record papers exposed to hormonal products

#1
Please share your experiences on handling (during auditing, archiving with document control) the papers of batch records which are exposed to hormonal (or health hazards) products..
Would appreciate insights on how to move these papers from these specially designed manufacturing areas to regular non-controlled auditing and document control areas..
The problem I am facing now is that there exists a possibility that trace quantities of product be present on these papers of batch records..Please do share experiences, thoughts!
 

v9991

Quite Involved in Discussions
#2
Re: Suggestions requested on handling batch record papers exposed to hormonal product

Have u thought about "containing" / "sealing" the documents + open-access to documents shall be restricted to reasonable controlled environment with specific personnel precautions.

Before that, to start with, it is recommended to have controls on exposure of documents to the processing area itself (viz., contemporaneous entry by supervisor such that exposure&contamination is minimized... but this adds complexity to maintaining data integrity related focus areas!)

Same problem manifests for asceptic processing where the risk is to product;

:2cents:
 

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