The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073405.pdf
Content:
This document describes a process for the evaluation and recommendation by the Q4B Expert
Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by
regulatory authorities for use as interchangeable in the ICH regions.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
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- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others