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  1. PDA TR 80

    Technical Report No. 80 (TR 80) Data Integrity Management System for Pharmaceutical Laboratories

    Report / Survey by Parenteral Drug Association, 08/01/2018.

    Languages: English

  2. PDA TR 79

    Technical Report No. 79 (TR 79) Particulate Matter Control in Difficult to Inspect Parenterals

    Report / Survey by Parenteral Drug Association, 03/01/2018.

    Languages: English

  3. PDA TR 78

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

    Report / Survey by Parenteral Drug Association, 01/01/2018.

    Languages: English

  4. PDA TR 54-5

    Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems

    Report / Survey by Parenteral Drug Association, 05/01/2017.

    Languages: English

  5. PDA TR 60-2

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

    Report / Survey by Parenteral Drug Association, 03/01/2017.

    Languages: English

  6. PDA TR 77

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

    Report / Survey by Parenteral Drug Association, 02/01/2017.

    Languages: English

  7. PDA TR 56

    Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance)

    Report / Survey by Parenteral Drug Association, 11/01/2016.

    Languages: English

  8. PDA TR 76

    Technical Report No. 76 (TR 76) Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging

    Report / Survey by Parenteral Drug Association, 10/01/2016.

    Languages: English

  9. PDA TR 75

    Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1?m Mycoplasma Reduction Filters

    Report / Survey by Parenteral Drug Association, 08/01/2016.

    Languages: English

  10. PDA TR 74

    Technical Report No. 74 (TR 74) Reprocessing of Biopharmaceuticals

    Report / Survey by Parenteral Drug Association, 06/01/2016.

    Languages: English