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
Annex 4C: Microbiological Examination of
Non-Sterile Products: Acceptance Criteria for
Pharmaceutical Preparations and Substances for