PDA Letter

Features | Aseptic Processing

Setting the Standard

Katharina Schlereth, Labor LS

Understanding FDA Complete Response Letters

Justin Johnson, PDA

PDA Capital Area Chapter Roundtable on Complete Response Letters Draws a Large Sunday PM Audience

Walter Morris, PDA
Previously Featured Articles

Aseptic Processing & Sterilization

Setting the Standard

Katharina Schlereth

HEPA Filter Management—Industry Survey Results

Brandon L. Stiff, CSSBB

Managing Ready-to-Use (RTU) Containers in Aseptic Production Facilities

Alliance for RTU and IMA Life

Three Sterility-Enhancing Technologies for Aseptic Life-Science Processes

PDA Staff Author: David Jaworski, MBA

Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem

Get Ecstatic for Aseptic

David Keen

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Biopharmaceuticals & Biotechnology

Disruption Potential of Injectable Anti-Obesity Therapies and Beyond

Mathias Romacker

Disruptive Innovations Shaping the GLP-1 Landscape

Anya Hillery, PhD, Freelance Medical Writer

The Need for Manufacturing Speed

Michael Anyadiegwu, PhD Renske Hesselink, PhD Ingrid Kromann

Breaking point: Assessing and Addressing the Risk of Auto-Injector Failure

Enrico Barichello

Microbial Ingress No Longer an Effective CCI Test Method

Oliver Stauffer Tyler Harris

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres Ana Marques Kuschel, PhD

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Manufacturing Science

Sponsored by Veolia

Validating Recombinant Endotoxin Reagents

Meg Provenzano

Sponsored by Kindeva

Bridging the Gap to Patients

Tommy Schornak

News Brief: PDA AI Glossary Now Available

Walter Morris, PDA

EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines

From Lab to Market

Tejesh Marsale

GMP Annex 1 Implementation

Andrea Salmaso

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People

On The Issue: IPM Microbiology, A Talk with the Editors

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Community News Quarterly | October 2025

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Community News Quarterly | July 2025

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Managing Talent Risk in Emerging Cell and Gene Therapy Biotechs

Tamer Helmy, PhD

Beyond the Vial

Philippe Lauwers Coralie Richard

PDA Spotlight: The Power of Networking and Innovating

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Quality and Regulatory

Setting the Standard

Katharina Schlereth

Reigniting PDA Puerto Rico

Justin Johnson, PDA

Navigating the AI Landscape

Peter Makowenskyj, MEng Toni Manzano

Understanding FDA Complete Response Letters

Justin Johnson, PDA

Driving Innovation in Pharma

Antonella Maggio Beth Haas Vinny Browning III

Building Maturity and Resilience Through Quality Culture

Annette Boland

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Supply Chain and Outsourcing

Who Picked That Supplier?

Dr. Jane Zhang Nazifa Rahman Anna Schniepp

Supply Challenges and Future Technologies in 2025

Deirdre Tobin Connie Leech

EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres Ana Marques Kuschel, PhD

The High Cost of Cheap Drugs

Martin VanTrieste

A Comprehensive Review of Regulatory Intelligence: Exploring Tools and Program Maturities

Jason Kerr Katie Bevard Maria Jacobs, PhD, Pfizer, Inc.

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PDA Letter's Top Articles

News Brief: FDA Unveils New Tools to Evaluate Drug Manufacturing Sites

Justin Johnson, PDA
HEPA Filter Management—Industry Survey Results

Brandon L. Stiff, CSSBB, Merck & Co.

Challenges in Sterilizing Indirect Product-Contact Surfaces

Cecilia Pierobon, STERIS

Q&A on the Revised PDA Technical Report No. 22

Subrata Chakraborty, PhD, INOVR , Vanessa Figueroa, VVF Science , and Marcia C. Baroni, MBA, Emergent BioSolutions Inc

PUPSIT and the Annex 1 Revision

Tina Morris, PDA, Maik Jornitz, G-Con, Gabriele Gori, GSK, and Hal Baseman, ValSource

Recent Articles (Past 60 Days)

Sponsored by Veolia
Validating Recombinant Endotoxin Reagents

Meg Provenzano, Veolia

Setting the Standard

Katharina Schlereth, Labor LS

Reigniting PDA Puerto Rico

Justin Johnson, PDA
Navigating the AI Landscape

Peter Makowenskyj, MEng, G-CON Manufacturing and Toni Manzano, PhD, Aizon

Understanding FDA Complete Response Letters

Justin Johnson, PDA
On The Issue: IPM Microbiology, A Talk with the Editors

PDA
Driving Innovation in Pharma

Antonella Maggio, Lesirg Consultants Inc. , Beth Haas, Haas Pharma Consulting LLC , and Vinny Browning III, Amgen, Inc.

Building Maturity and Resilience Through Quality Culture

Annette Boland, PharmaLex

A New Era for the PDA Journal

PDA JPST Editorial Team
PDA Capital Area Chapter Roundtable on Complete Response Letters Draws a Large Sunday PM Audience

Walter Morris, PDA
News Brief: FDA Unveils New Tools to Evaluate Drug Manufacturing Sites

Justin Johnson, PDA
HEPA Filter Management—Industry Survey Results

Brandon L. Stiff, CSSBB, Merck & Co.

MHRA’s Decentralized Manufacturing Regulation Set to Take Effect

Munyaradzi Japondo, PharmaLex

Accelerating Progress: How PDA Drives AI Innovation in Healthcare

Andrew Chang, Novo Nordisk, et al.
Managing Ready-to-Use (RTU) Containers in Aseptic Production Facilities

Alliance for RTU and IMA Life
News Brief: FDA Launches Pilot Program to Boost U.S. Generic Drug Production

Justin Johnson, PDA