Having been intimately involved in how the U.S. Food and Drug Administration (""FDA"") inspects current Good Manufacturing Practice (""cGMP"") requirements for nearly two decades, I find myself repeating certain things to companies. Most often, the issues I repeat relate to Corrective and Preventive Action (""CAPA"") systems. CAPA systems are a focal point in FDA inspections precisely because they are the process that manufacturers follow in case something goes wrong. In the same way that a person'
Most pharmaceutical and biotechnology companies already feel the pressure to reduce their R&D costs. A recent report showing a decline in the ROI for R&D among some of the world's biggest companies is not going to ease the pressure.
January 31, 2013
By Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
If you look at the cGMP regulations for dietary supplements, you'll notice that only one subpart includes the words "holding" or "distributing" in its title. With only 10 or so individual requirements, the aptly-named Subpart M, "Holding and Distributing," is shorter than most. If you're thinking this means there's a much lighter regulatory burden placed on companies that simply hold or distribute dietary supplements than on companies that manufacture them, you'd be right. At the same time, y
When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.
Outsourcing thrives in good times and bad. Life science companies rely on contract research organizations to complement in-house work in times of growth and expansion, but they also rely on CROs to reduce costs in times of financial downturn.
July 17, 2012
By Christine Park, Founder and Consultant, Christine Park & Associates
During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.
Combination products raise a variety of regulatory challenges. In addition to the unique technological and scientific challenges these products may raise, when drugs and devices, drugs and biologics or devices and biologics are combined to create a new product, consideration must be given to what regulatory requirements will apply to the combination product as a whole. This article explains the key principles and processes established for the assignment, premarket review, and postmarket regula
April 10, 2012
By Martin Browning, President and Co-Founder, EduQuest
Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.
January 31, 2012
By David R. Dills, Quality & Compliance Advisor
Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.
August 12, 2011
By Melissa J. Smith, Founder and Principal Consultant for MJQuality Solutions, LLC
This article provides an overview of the elements of transfer with references to supportive documents that contain more detail on the areas of interest regarding transfer and validation.
For the medical device industry, it's not always easy to understand and correctly implement FDA regulations. CDRH (Center for Devices and Radiological Health) is providing a free online educational tool with training modules that describe "many aspects of medical device and radiological health regulation [that cover] both premarket and postmarket issues."1
May 17, 2011
By Jim Shore, Product and Process Improvement Leader, Dynisco
The Poka Yoke method is something that improves your daily life; why not use it to make your product better, as well? The best solutions are simple, quick to implement and 100 times more effective than a 100-percent final inspection.
January 4, 2011
By Jennifer Stepniowski, Special Project Manager, Pro QC International
For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality-related issue and are looking to quickly extinguish the fire and prevent recurrences. Or they may simply want to reduce their overall risks—and costs—by incorporating a specific quality initiative.
If you're familiar with 21 CFR Part 11 documentation, you're likely acquainted with compliance audits, electronic record integrity and approval processes. However, you may wonder what the term "readily available" means or what "instantly" refers to in the same context. According to Labcompliance News1, it's these phrases that keep regulated companies guessing.
October 6, 2010
By Michael J. Gregor, President, Compliance Gurus, Inc.
Is your organization ready for an inspection of your Computer System Validation program? In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program. Often times, the FDA comes to inspect your facility for reasons other than your CSV program. However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. A
MasterControl's All Access solution is designed for life science professionals who need integrated, specialized solutions that address the many challenges in their unique work environments; for those professionals who have difficulty convincing management to invest in expert tools that would save the company money; for those who find that it's not cost effective to invest in general purpose tools that you only use once in a while; and for those who require a complete quality management system (Q
