How to find the key to Ph. Eur. Monographs?
![Serialization/Aggregation - Live Online Training](files/eca/userImages/training.img/Z-ECA-Serialization-Live-Online-Training.jpg)
Recommendation
23/24 October 2024
Requirements, Challenges & Solutions
As of the 10th Edition of the Ph. Eur., revised and / or corrected parts of texts are indicated by vertical lines, and horizontal lines indicate where parts of texts have been deleted (print version). In addition, a 2D- Code is included at the start of each text, providing a link to further information.
In Ph. Eur. Supplement 10.1 there is now an example monograph included (monograph carbimazole) to show more in detail which information is included, like for example:
- Version date of the text,
- Text reference number,
- 2D-Code which links to further information on the text (e.g. Knowledge database) for smartphones / tablets with camera and code reader app,
- When modifications have to be taken into account (i.e. for corrected texts: as soon as possible and not later than the end of the month following the month of publication of Supplement),
- Explanations and references to Ph. Eur. Reagents, General Notices and General Chapters.
Related GMP News
26.06.202410 points on how the FDA's CDER monitors the Quality of Medicinal Products
08.05.2024EMA Plans for the next three Years
30.04.2024Lean GMP: is "right-sizing" GMP and Compliance possible?
24.04.2024Unexpected Deviations: the Role of the QP
10.04.2024FDA's current Thinking on KPIs and Quality Metrics
21.02.2024What is the African Medicines Agency?