June 15, 2014
By Robin Nozick, MT(ASCP) CTO and Founder of R.F. Nozick and Associates
The blood establishment bears the responsibility for the regulatory compliance of the automated/computerized systems used. Full validation of the computerized system is required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control). The Quality Risk Management approach to validation advocated by GAMP 5 and ICH Q9, a life cycle approach within the QMS, and the use of risk assessments to define the validation strategy for
May 29, 2014
By James Jardine, GxP Lifeline Editor, MasterControl
Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.
April 3, 2014
By David Lim, President and Principal of Regulatory Doctor, and Yoonhee Beatty, Regulatory Affairs Associate, Bard Access Systems, Inc.
We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision. It is worthwhile to note and get familiarized with the available options. However, it is recommended the stakeholder try to avoid having such situations in the first place.
March 26, 2014
By John E. Lincoln, J.E. Lincoln and Associates LLC
Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.
Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”
January 24, 2014
By David Amor, CQA, MS Managing Partner, MEDgineering
Risk management is a sore point for a lot of start-ups during their product development programs. FMEAs, FTAs, ISO 14971- the sheer number of acronyms alone is staggering! I excitedly introduce you to another one – the MHL, or Master Harms List. Aligning product failures identified in risk management activities with their corresponding clinical harms sometimes becomes very labor intensive. In attempting to ensure that all relevant harms associated with a product’s component failures are captured, the engineer is presented with an expansive list of possibilities. Consumer risk is a permanent priority: thorough risk analysis is forever coupled with patient and physician safety.
November 12, 2013
By Jennifer Stepniowski, Special Project Manager, Pro QC International
The selection of a new supplier can be an arduous process, and the importance of the decision is inarguable. Changing suppliers when continuous improvement recommendations fail to succeed most surely will result in high switching costs. Ultimately, the decision is worth careful evaluation, which makes a grid analysis a useful and easy tool to use.
November 12, 2013
By Michael R. Hamrell, Ph.D., RAC, FRAPs, CCRA, RQAP-GCP, MORIAH Consultants
You have just been informed by your boss that the FDA is coming to conduct an inspection of a clinical study recently completed at your facility. Does this raise your anxiety level and that of your staff to near panic levels? A FDA inspection can bring on images in your mind of a large room, bright lights and grueling questions. Probably no other agency of our government can evoke a more frightening scenario, except for maybe an IRS audit. However, with proper planning and preparation, a FDA inspection does not have to be a nightmare experience.
August 14, 2013
By Steven Sharf, President and Principal Consultant, GMP Concepts
Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.
August 10, 2013
By Cathy L. Burgess, Donald E. Segal and Guillermo Cuevas,Alston & Bird LLP
Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with
July 10, 2013
By Tim Donaldson, President, Donaldson Group, Inc.
Predicting the future is fool’s play---think Edsel, Nostradamus, even Chicken Little. But if you or your organization is wrestling with what direction to take your quality programs and your entire organization, perhaps a brief look at history will aid in developing your future strategies and culture of quality.
May 4, 2013
By Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting
When I served in the military there was a term used that is still pretty familiar today: "sound general quarters!" When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel.
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
