Handling of Foreign Particles in APIs and Excipients - Live Online Training

5/6 February 2025

Course No. 21624

header-image

Speakers

Peter Mungenast

Peter Mungenast

Formerly Merck

Dr. Martin Melzer

Dr. Martin Melzer

Gempex

Dr Rajnish Kumar

Dr Rajnish Kumar

QAR Solutions

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

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 trainings 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.

Programme

Handling of Foreign Particles in APIs and Excipients - Live Online Training

Seminar Programme as PDF

Particles and Insoluble Matter in API Manufacturing: Why is it a Topic of Great Interest?
  • 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
Foreign Matter in Pharmaceutical Excipients – How to Deal with “Technically Unavoidable Particles” (TUPs)
  • 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
Foreign Particles – Quality Assurance Aspects
  • 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
Acceptance Criteria for Particles in APIs
  • Types of dosage forms and routes of administration
  • Typical limits for particle size seen via a filter test
  • Proposal for limits
Case Studies:
Deviations Caused by Foreign Particles
 
How Can Routine Cleaning Procedures Detect or Minimize the Presence of Particles in API Production?
  • Guides and Industry Standards regarding cleaning
  • Equipment cleaning
  • Production environment cleaning
  • Equipment design considerations
  • Detection/removal methods of particles
  • Preventive measures
Analytical Control Methods for Particle Detection
  • Design of appropriate analytical techniques
  • Understanding the operational and investigative analytical methodologies
Foreign Particles in Excipients and Finished Product Quality and Safety
  • Contamination profile of excipients meets finished product quality target product profile
  • Excipient process eisk analysis and TUPP/ particulate contamination profiling

stop

This course is part of the GMP Certification Programme "ECA Certified API Production Manager" Learn more

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023