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# Draft Guide on ICH Q12 Drug Manufacturing Annex
- URL: https://www.fdaweb.com/draft-guide-on-ich-q12-drug-manufacturing-annex/
- Published: 2018-05-31T12:00:00.000Z
- Updated: 2026-09-15T00:09:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141577

FDA has made available an International Council for Harmonization [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609366.pdf?ref=fdaweb.com) entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex” that provides examples of how to identify established conditions for drug manufacturing processes. The examples describe the relevant reporting categories for changes to the ranges of the manufacturing process parameters, controls or equipment. Having established conditions demonstrates that increased knowledge and understanding (e.g., enhanced development approaches) leads to reduction of uncertainty and improved risk management, FDA says.