ICH guideline
ICH Q4B Annex 4B(R1): Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q4B Annex 4B(R1) |
|---|---|
| Title | Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Annex was finalised under Step 4 in November 2008. This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter. This annex was revised (R1) on 27 September 2010 to include the Interchangeability Statement… |
| File | Q4B Frequently Asked Questions (FAQs) |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- Q4B Frequently Asked Questions (FAQs) Files published by ICH
- None FDA guidance documents based on this guideline
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About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.