• PDA TR 22

PDA TR 22

  • Technical Report No. 22, (TR 22) Revised 2011 Process Simulation for Aseptically Filled Products
  • Report / Survey by Parenteral Drug Association, 12/01/2011
  • Category: PDA

$325.00 $163.00

Technical Report No. 22 (Revised 2011), Process Simulation for Aseptically Filled Products, originally published in 1996. The Task Force charged with updating the document ensured that the new version reflects the continuing changes that have occurred in aseptic processing technology within the global industry over the last decade and a half. They have attempted to address the subject as fully as possible, recognizing the notable contributions by other organizations, regulators, compendia and individuals who have worked in this area. In addition the report provides guidance where risk-based approaches may be applied.
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PDA TR 77

PDA TR 77

Technical Report No. 77 (TR 77) The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-S..

$163.00 $325.00

PDA TR 60-2

PDA TR 60-2

Technical Report No. 60-2 (TR 60-2) Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Do..

$163.00 $325.00

PDA TR 54-5

PDA TR 54-5

Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Opera..

$163.00 $325.00

PDA TR 78

PDA TR 78

Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage Forms..

$163.00 $325.00