Một số hướng dẫn của PDA (Parenteral Drug Association)

 

PDA Technical Reports No.13 - Fundamentals of an Environmental Monitoring Program (Revised 2014)

PDA Technical Reports No.22 - Process Simulation for Aseptically Filled Products (Revised 2011)

PDA Technical Reports No.39 - Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment (2005)

PDA Technical Reports No.39 - Sterilization Filtration of Gases (2005)

PDA Technical Reports No.41 - Virus Filtration (2008)

PDA Technical Reports No.42 - Process Validation of Protein Manufacturing (2005)

PDA Technical Reports No.49 - Points to Consider for Biotechnology Cleaning Validation (2010)

PDA Technical Reports No.54-2 - Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling (2013)

PDA Technical Reports No.54-3 - Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products (2013)

PDA Technical Reports No.60 - Process Validation: A Lifecycle Approach (2013)

PDA Technical Reports No.68 - Risk-Based Approach for Prevention and Management of Drug Shortages (2014)

PDA Technical Reports No.70 - Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities

PDA Technical Reports No.82 - Low Endotoxin Recovery (2019)

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