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.
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.
August 19, 2021
By Samir Patel, Project Lead - Digital Systems, Sequence
Data integrity in the drug industry is a vital element to ensure the safety, efficacy, and quality of drugs. Data integrity has remained an industry buzzword for many years, but the experience the industry has gained from shortened timelines of COVID-19 vaccine development and manufacturing has further strengthened its importance.
June 30, 2021
By Arvilla Trag, RAC, Consultant, BioProcess Technology
Quality agreements between organizations and contract manufacturing organizations (CMO), particularly in pharma, can be crucial to increasing ROI for a manufacturer. But there is a right way and a wrong way to approach quality agreements. Learn some best practices on how to produce more efficient and effective quality agreements.
January 13, 2021
By David Jensen, Staff Writer, MasterControl
At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about the future of quality management. She identified some key strategies for how your organization can identify and understand quality assurance trends and develop initiatives for long-term success.
July 10, 2020
By Dale Thompson, Staff Writer, MasterControl
Manufacturing batch record trends from 2019 have picked up speed in 2020. Now is the time to focus on becoming data-centric, move to digital batch records, utilize the potential of workers on the shop floor, and create a truly paperless manufacturing environment.
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.
February 20, 2020
By David Jensen, Staff Writer, MasterControl
The pharma industry has been gathering no moss going into 2020. New pharmaceutical manufacturing trends have been rapidly emerging, accompanied by regulatory initiatives to help mainstream the innovations. A new trend brief from MasterControl discusses how the new trends will impact the pharma industry.
December 11, 2019
By Mike Rigert, Staff Writer, MasterControl
A recent U.S. Food and Drug Administration (FDA) report indicates one of the reasons for drug shortages in the U.S. is the absence of incentives for manufacturers’ facilities to go beyond minimal quality compliance. A proposed voluntary FDA ratings system based on objective criteria could potentially benefit and reward drugmakers for their facilities’ heightened quality manufacturing maturity.
September 24, 2019
By David Jensen, Staff Writer, MasterControl
Pharmaceutical manufacturing typically functions in a constant flurry of hard-to-satisfy demands, ranging from stringent compliance requirements and production schedules to developing strategies for continuous improvement. One of the presentations at the 2019 ISPE Annual Meeting and Expo, Oct. 27-30 in Las Vegas, will provide attendees with insight on how pharmaceutical companies are using digital technologies to avoid manufacturing obstacles while strengthening their competitive posture in the industry.
July 2, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Cloud networks, once shunned in the life sciences, have become essential tools for pharmaceutical organizations that want to keep pace with modernized competitors and an increasingly streamlined world. Learn about 10 distinct advantages cloud technology provides to pharma companies.
May 16, 2019
By Beth Pedersen, Staff Writer, MasterControl
Quality by Design (QbD) continues to be a hot topic across the life sciences industries. As more of the pharma sector implements pharmaceutical QbD, regulatory bodies work to further develop a common understanding of key concepts, terminology and expectations.
April 3, 2019
By Sandra Fadel, Product Management eCTD Templates and EURS Validator, EXTEDO
In order to maintain the highest standards, regulatory bodies are continually tweaking their drug registration requirements for highly controlled products. To keep up with these changes and avoid costly technical errors during the submissions process, pharma organizations are making sure they’re up to speed with regulators’ most up-to-date validation criteria.
February 21, 2019
By Beth Pedersen, Staff Writer, MasterControl
Let’s face it, winter is a euphemism for cold and flu season. Much like these inconvenient and disruptive viral infections wreak havoc on the human body, paper-based batch record processes can infect a manufacturing floor, slowing and compromising an otherwise healthy operation. Fortunately, an electronic batch record (EBR) solution can cure the disease.
November 15, 2018
By Joy McElroy, Consultant and Business Development Director, Maynard Consulting Company
Consumers and patients assume manufactured pharmaceuticals are safe and effective. In order for quality units to assure this, you have to have a robust quality control (QC) and quality assurance (QA) program guided by an equally sound quality management system (QMS). Learn the roles of QC and QA and how to create a QMS that will help your company maintain a high level of quality.
October 4, 2018
By Sarah Beale, Staff Writer, MasterControl
The nutraceutical world is constantly evolving to meet consumer needs and the search for alternative delivery forms is a prime example of this. To combat pill fatigue, supplements now come in liquids, powders, lotions and sprays, but companies embracing innovation need to be aware of the challenges they face.
July 31, 2018
By Tifany Desprez, Apsalys, a MasterControl Partner
France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.
July 12, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers.
Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.
July 10, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
FDA officials believe that artificial intelligence (AI) has the potential to bring about a step change in quality management in the pharma and medical device industries. Xavier Health has assembled a team of multidisciplinary experts to take a closer at the possibilities and roadblocks AI presents to quality management in both industries. Part 1 of a two-part series.
June 5, 2018
By Marci Crane, Staff Writer, MasterControl
Is the U.S. FDA about to approve the first cannabis-derived drug to win federal approval? In a recent FDA Advisory Committee meeting, a teenage boy addressed committee members. Sam, an epilepsy patient, was the first U.S. citizen to try Epidiolex, a cannabis-derived drug. Read about the future of medical marijuana.
