Peter Mungenast
Formerly Merck
Referent:innen
Dr. Martin Melzer
Gempex
Dr Rajnish Kumar
QAR Solutions
Karl-Heinz Freitag
Takeda Manufacturing Austria
Zielsetzung
During this Live Online Training all relevant aspects regarding the control of particles in APIs and excipients will be discussed.
You will learn
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.
Hintergrund
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.
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.
Zielgruppe
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 “.
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 Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programm
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
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
Recording from 28/29 Februray 2024
Duration Recording: 07:26 hrs
| ECA-Member*: | € 1690,- |
| Regular Fee*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified API Production Manager"
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E-Mail: info@concept-heidelberg.de
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