• PDA TR 3

PDA TR 3

  • Technical Report No. 3, Revised 2013 (TR 3) Validation of Dry Heat Processes Used for Depyrogenation and Sterilization
  • Report / Survey by Parenteral Drug Association, 07/01/2013
  • Category: PDA

$325.00 $163.00

PDA has revised Technical Report No. 3, originally issued in 1981. The revision offers a modern, scientific approach to dry-heat depyrogenation and sterilization processes and includes recommendations for use by industry and regulators. References to appropriate and current scientific publications, international regulatory documents, journal articles, technical papers and books are used where more detail and supportive data can be found.
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PDA TR 43

PDA TR 43

Technical Report No. 43, Revised 2013 (TR 43) Identification and Classification of Nonconformities i..

$163.00 $325.00

PDA TR 63

PDA TR 63

Technical Report No. 63 (TR 63) Quality Requirements for the Extemporaneous Preparation of Clinical ..

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PDA TR 33

PDA TR 33

Technical Report 33, Revised 2013 (TR 33) Evaluation, Validation and Implementation of Alternative a..

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PDA TR 64

PDA TR 64

Technical Report No. 64 (TR 64) Active Temperature-Controlled Systems: Qualification Guidance..

$163.00 $325.00