GxP Lifeline

Showing items tagged as Pharma

Ultimate Guide Spotlights Pharma Manufacturing’s Transition to Digitization

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.
Full story
Automated Visual Inspection Delivers Transformational Improvements in Pharmaceutical Manufacturing

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.
Full story
Data Integrity in Pharma is Key to Compliance

January 13, 2022 By Dale Thompson, Staff Writer, MasterControl

The FDA has signaled that data integrity is increasingly central to the drug approval process. Pharma organizations need to take the cue and adopt a quality management system that improves their ability to record and manage data, which will streamline their compliance efforts.
Full story
Pharma Manufacturers Are Modernizing to Improve Quality and Safety

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.
Full story
3 Keys to Meeting Pharma Regulators’ Data Expectations

December 14, 2021 By James Jardine, Staff Writer, MasterControl

FDA and other regulators are increasingly cracking down on pharma companies’ data integrity lapses. Learn the fundamentals of maximizing data usage that will help keep your quality and compliance activities aligned with regulatory expectations.
Full story
Why is Pharma Resistant to Digitization?

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 This outdated process is inefficient and can actually create more risk in the long run.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.
Full story
How to Avoid Pharma’s Top 5 FDA Form 483 Triggers

October 12, 2021 By James Jardine, Staff Writer, 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.
Full story
Ensuring Drug Accountability in Clinical Trials

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.
Full story
20 Years Later, 21 CFR Part 11 is More Relevant than Ever

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.
Full story
Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

August 11, 2021 By James Jardine, Staff Writer, MasterControl

The roles of regulatory operations professionals in the life sciences aren’t much different than those of air traffic controllers. They’re both focused on ensuring the safety of patients or passengers. Find out why regulatory operations experts are critical to companies’ speed of success and discover how advanced digital tools enable them to get products to more markets faster.
Full story
The European Qualified Person - What's It All About?

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.
Full story
How to Explain Your Quality Job to Young Kids in 4 Steps

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?
Full story
Understanding Auditor Checklists to Help Prepare for Audits and Inspections

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.
Full story
The Rise of Risk: How To Meet Pharma Regulators’ Expectations

June 23, 2021 By James Jardine, Staff Writer, MasterControl

Regulators are intensifying focus on risk-based compliance approaches and pharma companies must adapt to the shift. Discover why process digitization provides the surest route to compliant risk management and learn how to prepare for the increasingly risk-based future of regulation.
Full story
Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

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.
Full story
Risk Management: A Primer for Lean Quality Assurance

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.
Full story
3 Data Access Enhancements That Expedite Drug Development and Approvals

April 15, 2021 By James Jardine, Staff Writer, 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.
Full story
3 Practical Ways to Improve Infrastructure Agility in Pharma

April 6, 2021 By James Jardine, Staff Writer, 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.
Full story
Is Your CAPA Process Providing Adequate Return on Investment? If Not, Why Not?

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.
Full story
3 Practical Ways to Prepare for Pharma’s AI-Driven Future

February 9, 2021 By James Jardine, Staff Writer, MasterControl

Think only big pharma companies with deep pockets can benefit from artificial intelligence and other advanced technologies? Think again. AI is the future of pharma, and nowadays companies of all sizes are starting leverage it to streamline quality processes. Learn the pragmatic steps you can take today to position your company to get good returns on AI investments.
Full story