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  1. 2030656

    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

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  2. 2030655

    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

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  3. 2030654

    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

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  4. 2030629

    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

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  5. 2030427

    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

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  6. 2030653

    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

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  7. 2030632

    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

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  8. 2030652

    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

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  9. 2030651

    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

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  10. 2030650

    PDA TR 74▹

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

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

    Languages: English

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