Electronic PDA Technical Reports

PDA Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage Forms (single user digital version)

PDA Technical Report No. 78, Particulate Matter in Oral Dosage Forms documents the current practices used by manufacturers of drug products, active pharmaceutical ingredients, excipients, and packaging/primary containers to control, inspect, sample, and test intrinsic and extrinsic particulate matter in oral dosage forms. The scope of this Technical Report includes current practices of monitoring for particulates, as well as recent quality, clinical relevance, and regulatory experience in oral dosage forms.

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Format: PDF (1 file 1.05 MB)

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Table of Contents:

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  1. Introduction
  2. Glossary
  3. Background and Benchmarking
  4. Product Types and Formulations
  5. Sources and Mitigation
  6. Sampling, Testing, and Particle Identification
  7. Clinical Relevance
  8. Risk Assessment
  9. Conclusion
  10. References

Figures and Tables Index

Date of Publication: January 2018
ISBN Number: 9781945584008
Format: PDF
Number of Pages: 30