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The objective of PDA Technical Report No. 53: Guidance for Industry: Stability Testing to Support Distribution of New Drug Products is to describe and justify the studies using scientific data and rationale necessary to determine an appropriate stability budget for a drug product. This is the first of …

This technical report describes the overall quality system for distribution of pharmaceutical products and is meant to assist manufacturers in assuring that quality, integrity, and efficacy of the product are not compromised in the distribution channels, including handling, storage, transportation and …

As a result of a CGMP requirement that the parenteral manufacturer confirm supplier certification on packaging components, PDA Research Committee Task Group No. 14 developed test procedures that may be helpful in establishing the identity of elastomeric closure formulations.Clearance Sale 30% Off!Original …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.The validation of aseptic processing continues to be a major area of interest within the pharmaceutical industry. Five years …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.Many firms today have separate departments with different training requirements. Employees associated with the Microbiological …

This Technical Report was prepared by PDA Isolation Technology Task Force Members.The report addresses essential user requirements for the application of isolator technology to a broad range of manufacturing, development and testing applications in the health care product manufacturing industry. It covers …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This current revision to the technical report by the PDA Industry Advisory Board (IAB) reflects the lessons learned in four …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only. This Technical report was prepared by the PhRMA CSVWG and PDA Computer Related Systems …

PDA Technical Report No. 30 (Revised 2012): Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat provides current demonstrated best practices of this sterile product release method with an emphasis on use of science-based approaches during the development of a parametric release …

This Technical Report was prepared by the Joint PDA/PhRMA Sterile Bulk Pharmaceutical Chemicals Task Force. This document provides guidance relative to the validation of aseptic processing activities utilized for the production of sterile bulk pharmaceutical chemicals. It draws upon the concepts …

This Technical Report was prepared by PDA Task Force on Container/Closure Integrity. This report reviews issues of pharmaceutical product package integrity and provides guidance for evaluating the barrier qualities of a pharmaceutical package. It supersedes the previously issued PDA Technical Information …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This report was written to clarify the significant regulatory and technological issues impacting validation approaches and …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by Dr. James Agalloco and Dr. James Akers. This survey updates PDA 1992 aseptic processing …

Technical Report No. 22 (Revised 2011), Process Simulation for Aseptically Filled Products, originally published in 1996. The Task Force charged with updating the document ensured that the new version reflects the continuing changes that have occurred in aseptic processing technology within the global …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by Dr. James Agalloco and Dr. James Akers.It contains the results of a 1992 PDA survey …

This Technical Report was prepared by members of the PDA Validation of Tangential Flow Filtration in Biopharmaceutical Applications Task Force. PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications, updates the 1992 original version …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical report, the result of a grant to Julius Knapp and Patrick DeLuca, Ph.D., describes the various types of particulate …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by Dr. Y. John Wang and Dr. Yie W. Chien under the auspices of the PDA Research …

Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by the QC Subcommittee of the PDA Research Committee. This publication outlines methods …

This Technical Methods Bulletin was prepared by the Task Force 17.This bulletin is intended as a review of representative methods used by glass manufacturers to rapidly identify the various types of glass containers used by the parenteral drug industry. These methods may be used to assist in obtaining …