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  1. PDA TR 88

    PDA Technical Report No. 88 (TR 88) Microbial Data Deviation Investigations in the Pharmaceutical Industry

    Report / Survey by Parenteral Drug Association, 2022.

    Languages: English

  2. PDA TR 39

    Technical Report No. 39 (Revised 2021) Guidance for Temperature-Controlled Medicinal Products - Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment

    Report / Survey by Parenteral Drug Association, 2021.

    Languages: English

    Historical Editions: PDA TR 39

  3. PDA TR 87

    PDA Technical Report No. 87 (TR 87) Current Best Practices for Pharmaceutical Glass Vial Handling and Processing

    Report / Survey by Parenteral Drug Association, 2021.

    Languages: English

  4. PDA TR 86

    Technical Report No. 86 (TR 86) Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

    Report / Survey by Parenteral Drug Association, 04/30/2021.

    Languages: English

  5. PDA TR 85

    Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers

    Report / Survey by Parenteral Drug Association, 2021.

    Languages: English

  6. PDA TR 60-3

    Technical Report No. 60-3 Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances Manufacturing

    Report / Survey by Parenteral Drug Association, 01/01/2021.

    Languages: English

  7. PDA TR 13-2

    Technical Report No. 13-2 Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products

    Report / Survey by Parenteral Drug Association, 11/01/2020.

    Languages: English

  8. Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)

    Report / Survey by Parenteral Drug Association, 2020.

    Languages: English

  9. Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration

    Report / Survey by Parenteral Drug Association, 2020.

    Languages: English

  10. Points to Consider for Sensitivity to Oxidation by Peroxide

    Report / Survey by Parenteral Drug Association, 2020.

    Languages: English