Comment from Jitendra Pund
AnonymousSupportIndividual
Summary: Jitendra Pund suggests specific improvements to the guidance on documenting analytical procedures. The commenter recommends clearly identifying non-compendial procedures, referencing modified compendial procedures, and including an overview table to enhance transparency and consistency.
Dear Sir/Madam,
Please find here with my comments online number 604 to 610
Guidance on Documenting Analytical Procedures
This section should clearly identify all non‑compendial procedures, providing at minimum:
The name or internal code of each procedure
The material(s) to which the procedure applies
The purpose of the test
Where compendial procedures are applied, they should be referenced in the relevant control sections for each material. If a compendial procedure has been modified or adjusted by the applicant, the adjusted version must be described here.
To support transparency and consistency, an overview table may be included. This table should summarize all non‑compendial procedures and adjusted compendial procedures that form part of the control strategy (e.g., release testing, stability studies, in‑process controls [IPC]) across the different materials.
Regards
Jitendra Pund