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