Guest Columns
-
Agile Software Development In Bio/Pharma & Medical Devices, Part 3
7/25/2023
Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.
-
6 Ways To Achieve Manufacturing Audit And Inspection Readiness
7/19/2023
Achieving audit readiness is not a snapshot in time but an ongoing commitment to maintaining day-to-day compliance and quality standards. Let's explore how your manufacturing and quality teams can align efforts with these six practices to maintain audit and inspection readiness at all times.
-
Will You Sink, Survive, Or Thrive In This Biotech Market Correction?
7/18/2023
Over the past 18 months, biotech has undergone a major transformation, down from the “sugar high” of the biotech bull market and steady flow of capital in the early pandemic years. Arda Ural or Ernst & Young provides key tips for your biotech to survive and thrive during the current market correction until investment in the sector cycles back to more prosperous times.
-
Agile Software Development In Bio/Pharma & Medical Devices, Part 2
7/11/2023
Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.
-
The Cancer Drug Shortage: When Quality Fails
7/7/2023
Our industry is failing cancer patients with the current cancer drug shortage. Why is this happening and what can we do about it? This expert provides her insights from the perspective of a quality control professional.
-
Key Considerations In Selecting A Robotic Solution For Endotoxin Testing
7/6/2023
The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.
-
Combination Product QMS Requirements For The EU Market
6/30/2023
Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.
-
Key Post-Pandemic Trends In Global FDA Observations For Drug Facilities
6/29/2023
These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities.
-
Practical — And Crucial — Actions To Take Now For DSCSA Compliance
6/29/2023
Serialized data exchange, enhanced verification, and tracing, oh my! Many companies are still unprepared for full DSCSA implementation in November. Is your company one of them? Here are the important actions to take now.
-
Cleaning Process Development: Using Design Of Experiments To Determine Critical Process Parameters
6/28/2023
ASTM E3106 emphasizes that cleaning agents and cleaning processes should not be adopted randomly, nor should they be chosen simply based on what has been used in the past. In this article, part of the Cleaning Validation For The 21st Century series, let's look at which cleaning parameters are critical and what are the optimal cleaning parameter settings, through the lens of design of experiments (DoE).