|Non-ECA Members:||EUR 1790,--|
|ECA Members:||EUR 1590,--|
|EU GMP Inspectorates:||EUR 895,--|
|APIC Members:||EUR 1690,--|
(All prices excl. VAT)
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During this course all relevant aspects regarding the control of particles in APIs will be discussed. You will learn
Visible particles, insoluble particles or matter or foreign particles in Active Pharmaceutical Ingredients (APIs) and pharmaceutical excipients is a topic 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 excipients 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.
This course addresses 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.
Particles and insoluble matter in API manufacturing: why is it a topic of great interest?
Foreign Matter in pharmaceutical Excipients – how to deal with “Technically Unavoidable Particles” (TUPs)
Incident management – how to identify the source of insoluble matter
Acceptance criteria for particles in APIs
Good practices to minimise the presence of particles in APIs – key preventive measures
Foreign Particles in Excipients and Finished Product Quality and Safety