Quality Systems

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 2

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 1

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Part two of this article series shows how traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data of pharmaceutical processes with a reduced number of false alarms. 

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 2. Practical SPC Rules to Apply on Pharmaceutical Process Data

Meg Rivers is the former senior editor for 

Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units. 

Visual Inspection: Seeing Room for Improvement?

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.

Detecting and Determining Quantitation Limits for Impurities

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs. 

Pandemic Alters FDA Inspections and Quality Oversight

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits. 

The Remote Audit–A Tongue-in-Cheek Memo

 is an AFI member and participates in the AFI process validation working group.

Alessandro Regola is the AFI vice president in Milan and coordinator of the AFI Quality Section, and serves as pharmaceutical consultant in quality systems.

Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years

Pharmaceutical Knowledge Management: Experiences in Drug Development and Manufacturing

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

Quality Assurance/Quality Control