PDA TR 60-2

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.