You should have appropriate controls and documentation whenever you reprocess or rework an
API. You should keep accurate records, and you should show that the scientific staff directing
your development work has authorized and approved these activities. They should all be properly
recorded and documented so that one can look back through your laboratory notebook and
understand exactly what happened and how you processed that material.
Your scientific management should have determined that the reworking/reprocessing procedure
is appropriate. There is greater flexibility permitted under Q7A for materials still under
development.
