• PDA TR 54

PDA TR 54

  • Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Ope
  • Report / Survey by Parenteral Drug Association, 03/01/2012
  • Category: PDA

$325.00 $163.00

PCMOSM PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides detailed guidance for the application and implementation of quality risk management (QRM) principles throughout the product lifecycle. Intended to align with ICH Q9 and present information that can be helpful to the reader on how to implement QRM, the report emphasizes QRM application during commercial manufacturing and integrating QRM into the pharmaceutical quality system.
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PDA TR 54-4

PDA TR 54-4

Technical Report No. 54-4, (TR 54-4) Implementation of Quality Risk Management for Pharmaceutical an..

$163.00 $325.00

PDA TR 57-2

PDA TR 57-2

Technical Report No. 57-2, (TR 57-2) Analytical Method Development and Qualification for Biotechnolo..

$163.00 $325.00

PDA TR 69

PDA TR 69

Technical Report No. 69 (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Ope..

$163.00 $325.00

PDA TR 70

PDA TR 70

Technical Report No. 70 (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manuf..

$163.00 $325.00