Target Group
All participants get free access to the current version of the APIC’s „Guidance on Handling of Insoluble Matter and Foreign Particles in APIs “.
Objectives
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.
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.
Programme
- Definition of particles
- Types of particles
- Possible reasons for the elevated presence of visible particles
- Hints in guidances on how to deal with visible particles
- Inspectional observations
- Expectations of API manufacturers, API users, API suppliers and supervisory authorities regarding visible particles in APIs
- Understanding the nature of contaminants
- Establishing the target profile to support risk assessment
- Establishing the risk profile of unavoidable foreign particles
- Understanding the source and mitigation to minimise the foreign particles
- Potential sources of insoluble matter
- Root cause analysis – examples of investigation techniques and aids
- Risk assessment: topics to be considered during the investigation/disposition decision
- Types of dosage forms and routes of administration
- Typical limits for particle size seen via a filter test
- Proposal for limits
Deviations Caused by Foreign Particles
- Guides and Industry Standards regarding cleaning
- Equipment cleaning
- Production environment cleaning
- Equipment design considerations
- Detection/removal methods of particles
- Preventive measures
- Design of appropriate analytical techniques
- Understanding the operational and investigative analytical methodologies
- Contamination profile of excipients meets finished product quality target product profile
- Excipient process eisk analysis and TUPP/ particulate contamination profiling
Further Information
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Ms Anne Günster (Operations Director) +49(0)62 21 84 44 50, guenster@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald (Organisation Manager) +49(0)62 21 84 44 51, strohwald@concept-heidelberg.de.
Date & Time
Wed, 11 February 2026, 09:00 - 13:00 h
All times mentioned are CET.
Costs
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
(All prices excl. VAT). Important notes on sales tax.
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This course is part of the GMP Certification Programme "ECA Certified API Production Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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