CAPA Featured Articles
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Does Your Quality System Assure Products Are Safe And Effective?
3/26/2013
The Food and Drug Administration (FDA) guidance document (Quality Systems Approach to Pharmaceutical CGMP Regulations) references this clause as the basis for management review activities. The Q10 Guideline, published by International Conference for Harmonization (ICH) provides greater prescription and detail regarding the expectations of management review for the pharmaceutical quality system. Regardless of which reference document you use, a systemic review of the quality system activities is key to assuring continued suitability and effectiveness.
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Bad Quality Is Contagious: Stop Before It Spreads
1/25/2013
Disregarding the rules in the regulated industry is like a contagious disease. If you don’t control it in the beginning, you and your organization will be lost. In advanced stages, it could require the termination of many employees with this disease. When the FDA recommends you hire fresh eyes for quality systems on a warning letter, it actually means your problem is institutionalized. That’s why I recommend a biannual general audit by a third party. Even if you think you can go more than two years without an audit, this bad behavior can grow roots and can infect the quality culture of your organization. Then, when you do receive a visit from the FDA, it will be easier to correct unwanted behaviors and to renew your quality system, if needed. By Rosario Quintero-Vives, Sr. Regulatory & Compliance Specialist, RQV Consulting
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Implementing A Systemic Approach To Pharmaceutical Quality Systems
1/3/2013
In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn’t changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations. By Christine Park, Quality Architech
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3 Problems To Avoid When Establishing A Quality System
10/23/2012
For some products on the market, quality is a luxury or an option. However, when your product is under the FDA umbrella, quality is required by law if you want to do business in the United States. In the pharmaceutical industry, the customers we serve have very precise expectations when it comes to product quality — nothing but the best, with the highest standards of production and manufacturing. Because the end product affects people's lives, pharma companies aren’t afraid to pay whatever it takes to achieve quality.
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What Does Vertex Look For When Selecting A CRO?
5/24/2012
Peter A. DiBiaso is the head of clinical business operations for Vertex Pharmaceuticals and responsible for the leadership of clinical business operations in support of Vertex’s global development portfolio. By Rob Wright, Chief Editor, Life Science Leader magazine
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7 Ways To Prepare For An Inspection
5/16/2012
In the pharmaceutical, biopharmaceutical, and medical device industries, regulatory compliance is a major responsibility and a common source of anxiety. However, there’s no need to stress over the possibility of an FDA inspection — if you take the appropriate steps to prepare. This was the guidance Rosario Quintero-Vives, regulatory and compliance specialist with RQV Consulting, offered to a packed room of INTERPHEX 2012 attendees, on the potential problem areas to address before the FDA comes to call. She went on to highlight seven actions you can take to help make the inevitable FDA inspection go more smoothly. By Lori Clapper, Editor
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Setting Realistic Timetables For Deviations, Complaints, And CAPAs
Priorities are important to have in any environment, and regulated environments are no exception. When you are planning your quality system, you must keep your priorities top of mind; otherwise, regulatory agency visits could end in trouble. When you establish timetables to address any deviation of procedure, product complaints, or even CAPAs, you have to plan realistically — or you will put yourself and your business in a very tight position. Prioritization is critical because it can be difficult to remediate too many observations at once while you are still in production. By Rosario Quintero-Vives, Senior Regulatory and Compliance Specialist, RQV Consulting
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4 Steps To “Right Sizing” Your Personnel Resources To Support Quality
We all have them and we all need them. The real question is do you have the right resources? And, do you have enough to support your quality system? By Christine Park, Quality Architech