This webinar covers the major changes made to the general monograph, in particular where the testing and evaluation of particulate contamination is concerned. It also provides an insight into the draft general monograph on Monoclonal antibodies for human use (2031) that has been revised to bring it in line with Parenteral preparations (0520) with regard to visible particles.
The presence of foreign particles in liquid parenteral preparations (injections or infusions) represents a clinical risk to the patient and is therefore to be controlled and minimised. The general monograph Parenteral preparations (0520) has recently been revised to take into account current practices in the field, and provide requirements and recommendations for testing. The webinar will present the major changes made to the general monograph (published in Supplement 10.5 of the Ph. Eur.), in particular where the testing and evaluation of particulate contamination is concerned. It will also provide an insight into the draft general monograph on Monoclonal antibodies for human use (2031) (currently published in Pharmeuropa 33.4) that has been revised to bring it in line with Parenteral preparations (0520) with regard to visible particles. The term “practically free”, used in both texts, will be explained and recommendations given on how to interpret and implement it.
The webinar covers the following topics:
Parenteral preparations (0520) and referenced texts:
- requirements for particles;
- tests for particulate contamination – for both visible and sub-visible particles;
- new general chapter Recommendations on testing for particulate contamination: visible particles (5.17.2);
- latest revision of the general chapter Particulate contamination: sub-visible particles (2.9.19) including the ongoing harmonisation work with the Japanese Pharmacopoeia and United States Pharmacopeia.
- Monoclonal antibodies for human use (2031)
- background history with regard to requirements for visible particles;
- overview of rationale and proposed amendments (Production and Tests sections), with emphasis on aspects related to the inherent nature of monoclonal antibodies;
- update on the current status of the monograph revision.
Duration: 1 hour, 13 minutes.
Target audience
This webinar is of interest to professionals working in quality control/compliance, manufacturing and regulatory affairs, as well as in national regulatory agencies and inspection authorities.
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Other Events / Training Sessions
- Module 2: Individual Monographs
