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The concepts presented in PDA Technical Report No. 60-3 (TR 60-3): Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances Manufacturing are intended to assist in the design and implementation of globally compliant validation programs to ensure process reproducibility and …

La Monografìa Técnica No. 1 original de PDA, Validación de los Ciclos de Esterilización por Vapor, publicada en 1978, introdujo los principios de la esterilización por vapor a una generación entera de cientìficos e ingenieros farmacéuticos. La revisión mantiene un enfoque en microbiologìa e ingenierìa …

PDA Technical Report No. 13-2 (TR 13-2) Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products, is an addendum to PDA Technical Report No. 13 (TR 13, Revised 2014): Fundamentals of an Environmental Monitoring Program, which …

PDA Technical Report No. 84 (TR 84): Integrating Data Integrity Requirements into Manufacturing and Packaging Operations addresses data integrity from the perspective of manufacturing operations. It discusses regulatory trends, risk management concepts, and recommendations for implementing appropriate …

This Points to Consider document was developed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It provides the reader with points to consider on how to best implement and execute a pre-use/post-sterilization integrity test (PUPSIT) of the final sterilizing grade …

PDA's Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration summarizes the processes and outcomes of the risk Assessment and control mapping exercises performed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It describes …

PDA's Points to Consider for Sensitivity to Oxidation by Peroxide addresses aspects to consider in the design, development, processing, instrumentation, materials, and equipment specific to issues with products sensitive to oxidation when exposed to H2O2. This document primarily applies to isolator …

Focusing on important regulatory and technical updates surrounding isolator design, validation, and operations for aseptic processing, this Points to Consider addresses two primary types of isolators - open and closed - and is intended to support identification and use of modern technology. It does not …

PDA Technical Report No. 54-6, Risk Assessment for Excipients, is the sixth technical report (TR) in the TR 54 series related to various aspects of Quality Risk Management (QRM). It was developed to provide additional guidance on the excipient risk assessment process required by the European Commission …

The purpose of this technical report is to describe the proven, successful principles used and measures that can be taken to mitigate the risk of contamination by viruses and to provide guidance in effective preparation and response should such an event occur in manufacturing processes using in vitro …

El monitoreo ambiental es complementario a un programa de aseguramiento de esterilidad y es usado para evaluar la efectividad de controles microbianos utilizados en la fabricación de productos farmacéuticos estériles. PDA publicó por primera vez una guía sobre monitoreo ambiental en forma de Reporte …

This Technical Report aims to describe the underlying mechanisms and contributing factors of LER, summarize the potential clinical impact of the LER phenomenon, present guidelines for developing LER hold-time study design, and provide strategies for the mitigation of LER. Available to download. Prior …

This TR focuses on the development of a risk-based control strategy adapted to cell-based therapy that can mitigate the risk of generating a product of poor quality. Available to download. Prior to purchase please view the download instructions and Terms of Usage. Format: PDF (1 file 3.45 MB) Click …

This Technical Report, developed by subject matter experts from the global pharmaceutical industry and regulatory agencies, provides the framework and tools necessary to establish a robust data integrity management system to ensure data integrity for paper, hybrid, and computerized systems within the …

PDA Technical Report No. 79, Particulate Matter Control in Difficult to Inspect Parenterals describes best practices for difficult to inspect parenteral (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General …

PDA Technical Report No. 78, Particulate Matter in Oral Dosage Forms documents the current practices used by manufacturers of drug products, active pharmaceutical ingredients, excipients, and packaging/primary containers to control, inspect, sample, and test intrinsic and extrinsic particulate matter …

PDA's Points to Consider for Aging Facilities takes into account the industry's general thoughts and suggestions of the pharmaceutical manufacturing industry on how to identify and modernize aging facilities. This document reviews:How to recognize that a facility is aging Impediments to modernization …

PDA's Technical Report No. 54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems provides practical guidance on how to manage quality risks throughout the manufacturing system lifecycle and illustrates concepts through two case studies. The information …

PDA's Technical Report 60-2: Process Validation: A Lifecycle Approach - Oral Solid Dosage/Semisolid Dosage Forms Annex builds on and illustrates how concepts from TR 60 can be applied to oral solid dosage and semisolid dosage drug products so that the reader can gain a clear understanding of the application …

PDA's newly released Technical Report No. 77 (TR 77), The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology provides recommendations specific to the operation of blow-fill-seal (BFS) technology for the manufacture of sterile pharmaceuticals (e.g., ophthalmic, …