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.
PDA TR 51
PDA Technical Report No. 51 provides a comprehensive review of an area not adequately addressed in c..
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PDA TR 52
This technical report describes the overall quality system for distribution of pharmaceutical produc..
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PDA TR 53
The objective of PDA Technical Report No. 53: Guidance for Industry: Stability Testing to Support Di..
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PDA TR 54
PCMOSM PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and..
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PDA TR 54-2
The first Annex to Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceut..
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PDA TR 54-3
In the highly regulated pharmaceutical industry, it is important that significant risks be formally ..
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PDA TR 54-4
The goal of Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances is t..
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PDA TR 54-5
PDA's Technical Report No. 54-5, Quality Risk Management for the Design, Qualification, and Operatio..
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PDA TR 55
This PDA technical report provides guidance on how to detect and mitigate TBA and TCA odors and tain..
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PDA TR 56
PDA's newly revised PDA Technical Report No. 56, Revised 2016 Application of Phase-Appropriate Quali..
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PDA TR 57
Similar to the manufacturing process, an analytical method can also be considered a process. The val..
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PDA TR 57-2
This Technical Report provides practical, risk-based guidance for the development and qualification ..
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PDA TR 58
PDA Technical Report No. 58: Risk Management for Temperature-Controlled Distribution is meant to com..
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PDA TR 59
The purpose of Technical Report No. 59, Utilization of Statistical Methods for Production Monitoring..
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PDA TR 60
PDA's newest technical report Process Validation: A Lifecycle Approach presents timely and real worl..
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PDA TR 60-2
PDA's Technical Report 60-2: Process Validation: A Lifecycle Approach - Oral Solid Dosage/Semisolid ..
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