• 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.
PDF

All of our standards document are available in PDF (Portable Document Format), an electronic, downloadable format.You will be able to download the file in your account downloads.

Multi-User Access

After purchasing, you have the ability to assign each license to a specific user.

Printable

At any time, you are permitted to make printed copies for your and your members' reference use.

PDA TR 65

PDA TR 65

Technical Report No. 65, (TR 65) Technology Transfer..

$163.00 $325.00

PDA TR 66

PDA TR 66

Technical Report No. 66, (TR 66) Application of Single-Use Systems in Pharmaceutical Manufacturing..

$163.00 $325.00

PDA TR 67

PDA TR 67

Technical Report No. 67, (TR 67) Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceu..

$163.00 $325.00

PDA TR 68

PDA TR 68

Technical Report No. 68, (TR 68) Risk-Based Approach for Prevention and Management of Drug Shortages..

$86.00 $171.00