ICH guideline
ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q12 |
|---|---|
| Title | Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Steering Committee in September 2014. This new Guideline is proposed to provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Adoption of this new… |
| File | Q12 Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q12 Training Material Video Subtitles, Q12 Step 4 Presentation Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.