PDA Technical Report No. 60-2 (TR 60-2) Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (single user digital version)

Mar 2017
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PDA's Technical Report 60-2: Process Validation: A Lifecycle Approach - Oral Solid Dosage/Semisolid Dosage Forms Annex builds on and illustrates how concepts from TR 60 can be applied to oral solid dosage and semisolid dosage drug products so that the reader can gain a clear understanding of the application of the process validation lifecycle to these technologies. Legacy product validation and validation lifecycle enablers such as risk and knowledge management are also presented. Specific case studies are provided to illustrate how these concepts are addressed specifically for each dosage form.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Oral Solid Dosage Forms
  4. Semisolid Dosage Forms
  5. Applications of the Process Validation Lifecycle to OSD Prtoducts
  6. Application of the Process Validation Lifecycle to SSD Products
  7. Common OSD and SSD Considerations
  8. Legacy Product Validation
  9. Validation Lifecycle Enablers
  10. Case Studies
  11. References

Figures and Tables Index