Guidance on Handling of Insoluble Matter and Foreign Particles in APIs and Excipients (10665)

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...

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Note on quota call-off: When booking this webinar, one unit will be deducted per participant.