Column1

PDA TR No.

TR-1 2007

TR-3 2013

TR 12 1988

TR-13 2022

TR-13-2 2020

TR 14 2008

TR 15 2009

TR 21 1990

TR 22 2011

TR 25 1997

TR 26 2008

TR 27 1998

TR 28 2006

TR 29 2012

TR 30 2012

TR 31 1999

TR 33 2013

TR 34 2001

TR 38 2006

TR 39 2021

TR 40 2005
TR 41 2022

TR 42 2005

TR 43 2023

TR 44 2008

TR 45 2008

TR 46 2009

TR 47 2010

TR 48 2010

TR 49 2010

TR 50 2010

TR 51 2010

TR 52 2011

TR 53 2011

TR 54 2012

TR 54-2 2013

TR 54-3 2013

TR 54-4 2014

TR 54-5 2017

TR 54-6 2019

TR 55 2012

TR 56 2016
TR 57 2012

TR 57-2 2015

TR 58 2012

TR 59 2012

TR 60 2013

TR 60-2 2017

TR 60 -3 2021

TR 61 2013

TR 62 2013

TR 63 2013

TR 64 2013

TR 65 2022

TR 66 2014

TR 67 2014

TR 68 2014

TR 69 2015

TR 70 2015

TR 71 2015

TR 72 2015

TR 73 2015

TR 74 2016
TR 75 2016

TR 76 2016

TR 77 2017

TR 78 2017

TR 79 2018

TR 80 2018

TR 81 2018

TR 82 2019

TR 83 2019

TR 84 2020

TR 85 2021

TR 86 2021

TR 87 2021

TR 88 2022

TR 89 2023

TR 90 2023

PtC Part 1 2015

PtC Part 2 2016

PtC Aging Facilities

PtC Isolator

PtC PUPSIT 1 2020

PtC PUPSIT 2 2020

PtC Oxidation 2020

PtC Remote Inspection

PtC Hybrid Audit

PtC ATMP Manufacturing

Column2
Title
Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and
Ongoing Control

Validation of Dry Heat Processes Used for Depyrogenation and Sterilization

Siliconization of Parenteral Drug Packaging Components

Technical Report 13 Revised 2022, (TR 13) Fundamentals of an Environmental Monitoring Program

Fundamentals of an Environmental Monitoring Program Annex 1

Validation of Column-Based Chromatography Processes for the Purification of Proteins

Validation of Tangential Flow Filtration in Biopharmaceutical Applications

Bioburden Recovery Validation

Process Simulation for Aseptically Filled Products

Blend Uniformity Analysis: Validation and In-Process Testing

Sterilizing Filtration of Liquids

Pharmaceutical Package Integrity

Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals

Points to Consider for Cleaning Validation

Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist
Heat

Validation and Qualification of Computerized Laboratory Data Acquisition Systems

Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods

Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care
Products

Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry,

Manufacturing, and Controls Documentation

Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality of

Temperature-Sensitive Medicinal Products through the Transportation Environment

Sterilization Filtration of Gases

Virus Filtration

Process Validation of Protein Manufacturing

Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for
Pharmaceutical Manufacturing: Covering Ampoules, Bottles, Cartridges, Syringes and Vials

Quality Risk Management for Aseptic Processes

Filtration of Liquids Using Cellulose-Based Depth Filters

Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User

Preparation of Virus Spikes Used for Virus Clearance Studies

Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance

Points to Consider for Biotechnology Cleaning Validation

Alternative Methods for Mycoplasma Testing

Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification,

Manufacture, Control and Use

Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain

Guidance for Industry: Stability Testing to Support Distribution of New Drug Products

Implementation of Quality Risk Management For Pharmaceutical and Biotechnology Manufacturing

Operations

Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing

Operations Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling

Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing

Operations Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products

Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing

Operations Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances

Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems

Formalized Risk Assessment for Excipients

Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in

the Pharmaceutical and Consumer Healthcare Industries

Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic

Protein Drug Substance (API or Biological Active Substance)
Analytical Method Validation and Transfer for Biotechnology Products

Analytical Method Development and Qualification for Biotechnology Products

Risk Management for Temperature-Controlled Distribution

Utilization of Statistical Methods for Production Monitoring

Process Validation: A Lifecycle Approach

Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/Semisolid Dosage Forms

Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances

Manufacturing

Steam In Place

Recommended Practices for Manual Aseptic Processes

Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials

Active Temperature-Controlled Systems: Qualification Guidance

Tech Transfer

Application of Single-Use Systems in Pharmaceutical Manufacturing

Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and

Cosmetics

Risk-Based Approach for Prevention and Management of Drug Shortages

Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations

Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities

Emerging Methods for Virus Detection

Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance

Prefilled Syringe User Requirements for Biotechnology Applications

Reprocessing of Biopharmaceuticals
Consensus Method for Rating 0.1μm Mycoplasma Reduction Filters

Identification and Classification of Visible Nonconformities in Elastomeric Components and

Aluminum Seals for Parenteral Packaging

The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

Particulate Matter in Oral Dosage Forms

Particulate Matter Control in Difficult to Inspect Parenteral

Data Integrity Management System for Pharmaceutical Laboratories

Cell-Based Therapy Control Strategy

Low Endotoxin Recovery

Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response

Integrating Data Integrity Requirements into Manufacturing & Packing Operations

Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and
Glass Containers

Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Current Best Practices for Pharmaceutical Glass Vial Handling and Processing

Microbial Data Deviation Investigations in the Pharmaceutical Industry

PDA Technical Report No. 89 (TR 89) Strategies for Vaccine Development and Lifecycle
Management

PDA Technical Report No. 90 (TR 90) Contamination Control Strategy Development in
Pharmaceutical Manufacturing

Points to Consider for Aseptic Processing: Part 1, January 2015

Points to Consider for Aseptic Processing: Part 2, May 2016

Points to Consider for Aging Facilities

Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators

Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration
oints to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing

Points to Consider for Sensitivity to Oxidation by Peroxide

Points to Consider in Remote and Hybrid GMP/GDP Inspections

 Column3
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Column1
ISPE Document
Column2
Title

GAMP 5 Guide 2nd Edition

GAMP Guide: Records & Data Integrity

GAMP Good Practice Guide: Calibration Management 2nd Edition

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: Enabling Innovation

GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition

GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd
Edition

GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition

GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition

GAMP Good Practice Guide: Manufacturing Execution Systems

GAMP Good Practice Guide: Operation of GxP Computerized Systems

GAMP Good Practice Guide: Regulated Mobile Applications

GAMP Good Practice Guide: Testing GxP Systems 2nd Edition

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

GAMP RDI Good Practice Guide: Data Integrity by Design

Good Practice Guide: Assessing Particulate Containment 2nd Edition

Good Practice Guide: Asset Management

Good Practice Guide: Booklet Labels

Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition

Good Practice Guide: Clinical Supply Systems

Good Practice Guide: Cold Chain Management

Good Practice Guide: Comparator Management

Good Practice Guide: Containment for Potent Compounds

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

Good Practice Guide: Controlled Temperature Chambers 2nd Edition

Good Practice Guide: Critical Utilities GMP Compliance

Good Practice Guide: Decommissioning Pharma Equipment & Facilities

Good Practice Guide: Development of Investigational Therapeutic Biological Products

Good Practice Guide: Equipment Reliability

Good Practice Guide: Good Engineering Practice 2nd Edition

Good Practice Guide: Harmonizing the Definition and Use of NIMPs

Good Practice Guide: Heating, Ventilation, & Air Conditioning (HVAC)

Good Practice Guide: HVAC & Process Equipment Air Filters

Good Practice Guide: IMP Reverse Logistics

Good Practice Guide: Interactive Response Technology

Good Practice Guide: Knowledge Management in the Pharmaceutical Industry
Good Practice Guide: Maintenance 2nd Edition

Good Practice Guide: Management of Engineering Standards

Good Practice Guide: Membrane-Based WFI Systems

Good Practice Guide: Operations Management

Good Practice Guide: Ozone Sanitization of Pharma Water Systems

Good Practice Guide: Packaging, Labeling, & Warehousing Facilities

Good Practice Guide: Process Gases

Good Practice Guide: Process Validation

Good Practice Guide: Project Management for the Pharmaceutical Industry

Good Practice Guide: Quality Lab Facilities

Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases

Good Practice Guide: Single-Use Technology

Good Practice Guide: Technology Transfer 3rd Edition

Baseline Guide Vol 1: Active Pharmaceutical Ingredients

Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

Baseline Guide Vol 4: Water & Steam Systems 3rd Edition

Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 2nd Edition

Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition

APQ Guide: Change Management (CM) System

APQ Guide: Corrective Action & Preventive Action (CAPA) System

APQ Guide: Cultural Excellence

APQ Guide: Management Responsibilities & Review (MRR)

APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)

PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles

PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example

PQLI Guide: Part 3 - Change Management System

PQLI Guide: Part 4 - Process Performance & Product Quality Monitoring System

Guide: ATMPs - Autologous Cell Therapy

Guide: Biopharmaceutical Process Development & Manufacturing

Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

Handbook: Sustainability

Comprehensive Guide to Clinical Materials

Introductory US Clinical Trial Materials Training Guide

Investigational Materials Sample Retention Guide

D/A/CH Affiliate: WFI Handbook (English Translation)

Japan Affiliate: Pest Control Manual (English Translation)

 Column3
Availability