Guidance on Handling of Insoluble Matter and Foreign Particles in APIs and Excipients
The description, assessment and documentation of impurities in drug substance, excipients, drug product and packaging material are an essential part of the quality and safety of a drug during its life cycle. The main frame and rules are documented in official guidelines and pharmacopoeias; however, not all relevant aspects are covered by the regulatory documents and leave room for interpretation and open questions. One of these topics is foreign particles in medicinal products; they have to be considered and assessed, but a clear guidance is missing.
This webinar will provide answers to open questions and cover the following aspects:
Highlights
- Key preventive measures to minimise foreign particles
- How to deal with technically unavoidable particles in excipients
- Acceptance criteria for particles in APIs
- How to identify the source of insoluble matter
- Analytical control methods for particle detection
- How to minimise the presence of particles – strategies for cleaning and detection
- Foreign particles in excipients and finished product quality and safety
Possible Points to be covered:
- Definitions of particles
- Particles in final APIs
- Particles in API intermediates
- Particles in raw materials (including packaging materials) for APIs
- Good practices to minimse the presence of particles in APIs
- Key preventive measures
- Removal / detection methods
- Inspection methods
- Analytical controls and acceptance criteria
- Analytical methods for APIs
- Appearance test
- Filter test
- Sampling and sample size
- Preventive measures for test execution
- Test execution
- Acceptance criteria for APIs
- Dosage forms and routes of administration.
- Limits
- (In-)Process controls for intermediate process steps
- Incident Management
- Determination of the identity of particles
- Identify source – examples of investigation techniques and aids
- CAPA / course of action to avoid reoccurrence
- Risk assessment: topics to be considered during investigation & disposition
- Decision
- Analytics
- Extensive methods for the isolation of particulate matter, for example manipulation of small particles, filtration and centrifugation
- Optical microscopy with image analysis
- Scanning electron microscopy with EDX for qualitative elemental analysis of particles
- High Resolution SEM with Field Emission Gun
- FT-IR microscopy
- Raman microscopy
Duration: 150 minutes
Lecture language: English | Slides: English
...your speaker Dr. Helmut Buschmann...
...your speaker Dr. Norbert Handler...
We offer attractive special prices with special benefits for large groups - please contact us.
Note on quota call-off: Please note that this webinar cannot be booked using an existing 10-webinar quota.
- Dr. Helmut Buschmann
RD&C Research, Development & Consulting GmbH - Dr. Norbert Handler
RD&C Research, Development & Consulting GmbH
E-Learning | Streaming in MP4 format (EN)
Prizes & Conditions of Participation
per person plus VAT. - Payment upon receipt of invoice.
The fee includes for a single booking:
- the one-time viewing of the booked webinar/ or webinar series by the person(s) named to us in advance.
- the receipt of the slides shown as a printable PDF file.
The training is personal and, if booked individually, is for personal training purposes only - not for an entire team. We thank you for your fairness.
Cancellation or change of person is not possible after sending the handout (live: usually 1-2 days before the event | recording: immediately).
Full terms and conditions and participant information can be found here.
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Special prices for team bookings:
If the training is of interest to a group of colleagues, please contact us. Here we offer special group prices for you as a company. The group size is limited to a maximum of 30 participants per webinar. You can participate live or stream the webinar at an individual later time in our video library.
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Save money by booking a quota of 10 and combine any 10 individual webinars (90 min. each) from the topics offered.
Price: 2,500.- € per contingent plus VAT.