Chemistry Reference
In-Depth Information
A.9 protocol Amendments
This section should describe how amendments and deviations to the protocol should
be handled, how approved, etc.
A.10 regulAtory complIAnce
This section should describe what level of regulatory compliance is applicable
(cGMP, cGLP, research only).
A.11 reFerences
Include all regulatory, SOP, literature, and internal references as appropriate.
A.12 AppendIces
This section should include the draft method if available (and not detailed in the
body of the protocol), data forms used to record data, analyst notes, and any other
pertinent information necessary to carry out the work instructions in the protocol.