December 6, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Effective corrective action/preventive action (CAPA) management isn’t just a regulatory requirement – it has a direct and measurable impact on product quality. If you want to optimize and simplify CAPA, these best practices provide the perfect starting point.
October 4, 2022
By Kevin Ballard, Senior Project Manager, Validation on Demand, MasterControl
The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.
August 16, 2022
By Ave Love, Staff Writer, MasterControl
End-of-line quality control comes too late in a competitive market. Regulators have long emphasized the systematic integration of quality within manufacturing processes to yield safer and more efficient pharmaceuticals. Get clarity on the role of Quality by Design (QbD) in modern pharma manufacturing and learn why a purpose-built quality management system is the most effective means of implementing it.
April 5, 2022
By David Jensen, Staff Writer, MasterControl
Numerous pharma companies are adopting digitization to ensure long-term relevance in the value chain. This post highlights MasterControl’s “The Ultimate Guide to Digitizing Pharma Manufacturing,” which takes an in-depth look at how the industry is transitioning to modernized operations.
March 21, 2022
By Steve Holbrooks, Project Manager, MustardSeed
Pharma manufacturers that adopt machine vision technologies are finding faster ways to detect and contain defects and avoid waste and rework. Learn why automated visual inspection (AVI) systems are the key to enhancing quality and productivity in evolving manufacturing environments.
January 6, 2022
By David Jensen, Staff Writer, MasterControl
Given the high numbers of pharmaceutical recalls and shortages, along with the current supply chain issues, product manufacturers are making modernization a higher priority. This post examines the new pharmaceutical manufacturing trends in modernization.
November 11, 2021
By James Irons, Director of Strategic Development, and Samir Patel, Project Lead - Digital Systems, Sequence
The pharmaceutical manufacturing industry resists digitization and continues to rely on paper as a single source of truth for record keeping. This outdated process is inefficient and can actually create more risk in the long run. Understand the primary causes of resistance to digitization and how to address those barriers.
October 12, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Form 483 inspectional observation reports from the FDA result in painful and costly nightmares for pharmaceutical companies. Learn the top five reasons the agency issues Form 483s and find out best practices for steering clear of them.
September 13, 2021
By Sarah Beale, Staff Writer, MasterControl
Drug accountability in clinical trials holds the organizations and people involved accountable for how they handle the drug being used. Accurate records are essential for compliant and reliable results.
August 17, 2021
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.
July 28, 2021
By Wolfgang Schmitt, Vice President, Concept Heidelberg
According to good manufacturing practice (GMP) guidelines, companies in regulated environments must adhere to regulations that apply to the development of health care products. For medicinal product manufacturers in the European Union (EU), the person responsible for batch certification and the majority of quality processes is the Qualified Person (QP). This article details the duties and responsibilities of the QP and explains why it’s important for U.S.-based companies to understand the QP’s role.
July 19, 2021
By Lillian Erickson, Global Quality Manager, MasterControl Inc.
When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?
July 8, 2021
By David Butcher, Staff Writer, MasterControl
A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.
May 19, 2021
By Dale Thompson, Staff Writer, MasterControl
All eyes are on contract manufacturers to help make COVID-19 vaccinations available throughout the globe. Increased scrutiny of the industry has brought an issue to the forefront: maintaining product quality while working at a rapid pace. With a modern manufacturing solution, it’s possible to prioritize both.
May 7, 2021
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
Be proactive about managing risk. If you aren’t, you will find yourself managing a crisis instead. Learn more about the benefits of risk management and how it’s done.
April 15, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Regulators began increasing focus on data accuracy long before the pandemic, but it’s a trend that’s only continuing to gain more momentum. Discover how data connectivity improvements are helping pharma companies align with regulatory dynamics and get drug products to market faster.
April 6, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
If nothing else, the COVID-19 pandemic proved to pharmaceutical companies that digitally integrated processes are the key to surviving a crisis. If your organization has difficulty connecting people, processes, and systems, there are three pragmatic measures you can take to bolster your existing infrastructure, help ensure secure connections, and enhance collaborative work.
February 15, 2021
By Christine Park, Founder and Consultant, Christine Park & Associates
The FDA has increased focus on the effectiveness of failure investigations during inspections in recent years. A review of 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to truly identify root cause.
December 21, 2020
By David Jensen, Staff Writer, MasterControl
Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.
May 28, 2020
By Mukul Dakwale, Principal Consultant, Luceats Consulting
An array of advanced technology and digitization are rapidly changing the landscape of pharmaceutical manufacturers and their supply chains. Mukul Dakwale, principal consultant at Luceats, explains how formulating a digitization strategy and implementation plan can help your pharma company transition from disparate, manual data systems toward end-to-end automation.
