Bookstore Search

This Points to Consider document describes steps that can be taken to ensure an effective and efficient remote assessment. It introduces standard nomenclature to describe the types of remote audits and discusses key considerations for their scheduling, duration, planning, conduct, closing, …

This revision of TR 13 aligns with current industry trends and regulatory expectations and provides additional guidance and focus on increased expectations concerning data management and data integrity, qualification and maintenance of controlled environments, and rapid microbiological methods …

The Product Quality Research Institute (PQRI) Leachables and Extractables (L&E) Working Group provided recommendations to the US Food and Drug Administration in 2006 on safety thresholds and best demonstrated practices for orally inhaled and nasal drug products (OINDP). The published PQRI E&L …

ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue ProductsThis new standard provides …

This technical report presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the …

This technical report provides guidance for establishing a quality management system for distribution of all types of temperature-sensitive medicinal and pharmaceutical products. This guidance covers the shipping site, where the product is prepared for transportation, and the shipment of the …

This technical report focuses on a technical understanding of glass, its strength, and its limitations, and provides guidance in best handling practices for glass vials throughout the pharmaceutical process — receipt, storage, preparation, filling, stoppering, freeze-drying, and capping. This document …

This new standard describes a filter challenge test for standardizing test parameters across laboratories using 47 mm discs and using A. laidlawii as the test organism. While this standard is primarily to educate users and filter manufacturers about best practices for mycoplasma reduction …

There are very few documents available that provide guidance regarding to requirements for non-sterile drug manufacturing. The Kansai Study Group (KSG) of the PDA Japan Chapter (JPDA) published this paper to offer some consensus-based ideas to help pharmaceutical manufacturers establish appropriate, …

Remote assessments increasingly are seen as useful tools in obtaining meaningful insights into a site's operations. But what factors should companies and health authorities consider when adjusting to a remote inspection format? How do you determine, address, and plan for the technological hurdles and …

This technical report is a consensus-based resource surrounding the challenges encountered in using complex package systems and introduces important elements to consider in decision-making. It also offers an examination of the technologies available for package integrity testing not yet established by …

Visual inspection of filled injectable products is an important part of the control strategy of the manufacturing process. It offers a means to improve quality by removing noncompliant units and provides information to drive continuous process improvement. This technical report addresses test and inspection …

The 2020 PDA Research Particulate Matter in Flexible Containers Survey was undertaken to address the industry-wide concern raised by multiple recalls for particulate matter in flexible container and other container products dating back to 2012.This survey was conducted to establish a benchmark of current …

In this book you will find many different approaches to conducting compliant investigations, where compliant is defined as meeting the requirements of the applicable regulatory documents. The information it provides on conducting investigations that will be acceptable to regulatory investigators will …

This chapter is taken from the book Fungi: A Handbook for Life Science Manufacturers and Researchers, edited by Jeanne Moldenhauer.There is a major gap in understanding fungi in general and mold specifically in the pharmaceutical industry. Most mycologists are in academia and fungi are not taught in …

PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, edited by industry experts Cristiana Campa, Vaccines Technical R&D, GSK, and M. Amin Khan , Vaccines R&D, GSK, is an important contribution to the ongoing dialogue for accelerating …

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 …

This timely and informative text discusses aspects of contamination control in cleanrooms seldom described in detail in the literature. The increasing number of warning letters, product recalls and 483 observations related to both particulate and microbial contamination indicates that contamination control …

ANSI/PDA Standard 04-2021 Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters addresses the use of virus-removal filters that retain viruses by a size-exclusion mechanism. This document should be considered as a guide intended to provide filter suppliers with an approach …

The 2021 PDA Post-Approval Change Issues and Impacts Survey provides experts' views on the most significant post-approval change issues faced by manufacturers of drug products (DPs) and active pharmaceutical ingredients (APIs). By understanding the challenges that industry faces in making manufacturing …