PDA STANDARDS PDF The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community.
This technical report complements PDA Technical Report No. 1 (Revised 2007): Validation of Moist Hea..
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The purpose of this technical report is to outline methods and approaches for control and evaluation..
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A recent benchmarking exercise conducted by the PDA Quality Requirements for the Extemporaneous Prep..
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Fundamental to any temperature-controlled process is the expectation that materials that are stored ..
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PDA Technical Report 65 (TR 65): Technology Transfer provides an overview of the knowledge and skill..
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PDA TR 66 discusses single-use systems that are in either direct or indirect contact with raw materi..
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The purpose of TR 67 is to provide guidance to the nonsterile product manufacturing industry on how ..
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Drug shortages and supply disruptions are increasingly emerging as a global challenge. As part of th..
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PDA Technical Report No. 69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturin..
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PDA Technical Report No. 70, (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic ..
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Technical Report No. 71, Emerging Methods for Virus Detection describes and critically assesses meth..
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PDA Technical Report No. 72 (TR 72) Passive Thermal Protection Systems for Global Distribution: Qual..
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PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applicatio..
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This technical report provides guidance in the design, development, controls, procedures, validation..
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PDA's newly released Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1?m Mycoplasma Re..
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PDA's newly released Technical Report No. 76 (TR 76) Identification and Classification of Nonconform..
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