Handling of Foreign Particles in APIs and Excipients - Live Online Training
5/6 February 2025
Course No. 21624
Speakers
Peter Mungenast
Formerly Merck
Dr. Martin Melzer
Gempex
Dr Rajnish Kumar
QAR Solutions
Karl-Heinz Freitag
Takeda Manufacturing Austria
All times mentioned are CET.
Objectives
During this Live Online Training all relevant aspects regarding the control of particles in APIs and excipients will be discussed.
You will learn
How potential sources of insoluble matter can be identified
Which acceptance criteria for particles can be applied
How good practices to minimise the presence of particles in APIs can look like
What has to be considered regarding control of particles during plant and equipment maintenance and cleaning
How a particulate contamination profile can be established.
Background
Visible particles, insoluble particles or matter or foreign particles in Active Pharmaceutical Ingredients (APIs) and pharmaceutical excipients are topics of great interest and of importance to the pharmaceutical industry.
A number of inspectional observations from various Regulatory Authorities related to visible particles in Drug Products and APIs has risen considerable concern. Moreover inappropriate methods of investigation, controls and preventive and corrective actions were all subjects of citations by authorities and observations by API and excipient customers.
Particles have always been present in APIs and excipients but guidance from health authorities (EMA, FDA, others) or Pharmacopoeias (e.g. EP, USP) about particles is very limited. The APIC Guidance on Insoluble Matter and Foreign Particles in APIs and the IPEC Guide on “Technically Unavoidable Particle Profile (TUPP)" are the only best practice documents so far providing guidance for a standard approach towards an appropriate control of foreign particles in APIs and pharmaceutical excipients.
Target Group
This Live Online Training is addressed to employees and senior staff of pharmaceutical companies and manufacturers of APIs and excipients. The course is of particular interest to all those working in quality assurance, quality control, production and purchasing departments.
All participants get free access to the current version of the APIC’s „Guidance on Handling of Insoluble Matter and Foreign Particles in APIs “.
Technical Requirements
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Testimonials
Seminar Programme as PDF