Examples of Analytical Method Implementation
![Ph. Eur., USP and other Pharmacopoeias - Live Online Training](files/eca/userImages/training.img/Z-ECA-PhEur-USP-and-other-Pharmacopoeias-Live-Online-Training.jpg)
Recommendation
17/18 September 2024
Dealing with different compendial methods
Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures (Ph. Eur. 11.0), the EDQM published some examples. The intention is to provide users with practical guidance on how critical factors potentially affecting the Analytical Procedure Performance Characteristics (APPCs) can be identified. However, it is emphasized, that the pre-requisite for the implementation of any analytical procedure is a suitable quality system, which ensures that the requirements set for personnel, premises, and equipment are fulfilled.
Examples for Critical Factor Assessment
The following six examples are provided for the assessment of critical factors associated with the analytical procedure under actual conditions:
- Pharmaceutical ingredient (Mannitol) / Identification by infrared absorption spectrophotometry
- Drug product (Deferiprone tablets) / Related substances test by LC-UV
- Active substance (Benzylpenicillin potassium) / Assay by LC-UV
- Infliximab concentrated solution / Cell-based assay procedures
- Drug Product (Deferiprone oral solution) / Microbial enumeration test
- Active substance (Deferiprone) / Sulfated ash
More information is available in the Examples of implementation of pharmacopoeial procedures according to Chapter 5.26 "Implementation of pharmacopoeial procedures” published in Pharmeuropa Online under Technical Information.
Related GMP News
12.06.2024NMPA Announcement on Application of ICH Q2(R2) and Q14 Principles
22.05.2024Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 1
22.05.2024FDA Warning Letter to Contract Testing Laboratory in Uruguay due to Data Integrity Violations
22.05.2024European Pharmaceutical Review Article on ICH Q2(R2)
15.05.2024 Further Warning Letter with multiple Deviations to a Korean Company