ICH guideline
ICH Q4B Annex 2(R1): Test for Extractable Volume of Parenteral Preparations General Chapter
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q4B Annex 2(R1) |
|---|---|
| Title | Test for Extractable Volume of Parenteral Preparations General Chapter |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Annex was finalised under Step 4 in June 2008. This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. This annex was revised (R1) on 27 September 2010 to include the Interchangeability Statement from Health Canada, Canada. |
| File | Q4B Frequently Asked Questions (FAQs) |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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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.