Notification #42 September 2026

Guideline Document Updates

Two additional sections have been added to the HPUS Homeopathic Good Manufacturing Practices Guidelines. One [Sec. §10] addresses issues related to finished product testing considerations. The second [Sec. §11] provides information on a suggested process validation approach for the attenuation procedure; this is a method based on procedures already accepted by FDA for circumstances which do not lend themselves to customary process validation methods.

The new sections implement ideas expounded upon in the various White Papers posted in 2024 by the Convention and revised in 2025 after receiving public comments.Due to the additions, the former Sec. §10 has be renumbered to Sec. §12.