This Guidance document is used to develop, streamline, simplify and align the Master Batch Records and associated documentation. The records addressed include all major manufacturing equipment and processes, industry ‘best’ good documentation practices, and facilitates compliance with cGMPs and other mandated requirements.
When the Guidance document concepts have been tested through the initial redesigned Master Batch Record(s), the document becomes the basis for redesigning and maintaining all manufacturing Batch Records within an organization.
The establishment of production Batch Record guidelines will:
When we develop your guidelines, the following are assessed:
To learn more about Batch Record Guidance and Good Documentation Practices Contact Us.