ARTICLES BY MARK DURIVAGE
The 10 Phases Of An Effective CAPA
Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.
Packaging Good Manufacturing Practices (GMPs) For Medicinal Products
Has your primary packaging materials supplier established, implemented, and maintained an adequate quality management system? The requirements of ISO 9001 may not provide the necessary levels of GMPs and rigor to ensure the packaging materials are adequate for their intended use.
Design Of Experiments 101: Understanding DOE’s Foundational Elements
DOE is a very powerful tool that can be used to characterize a process. This article discusses several types of experiments, as well as the basic statistical tools and techniques, that can be used when performing a DOE.
Process Characterization: The Foundation For Validation
Process validation should never be performed until the process is fully characterized. A failed process validation should be a rare event; otherwise, a Warning Letter will probably be in your future.
An Introduction To Sampling Plans
Sampling plans are used extensively throughout organizations regulated by the FDA. Most have a statistical procedure that specifies a certain acceptable quality level based on risk. (If not, they should!) However, most follow the requirements of the procedure without fully comprehending how sampling plans actually work. This is why you should.
Is Your Personnel Hygiene Plan Up To Date?
Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.
How To Prepare For An FDA Inspection
An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.
Military Tool For Vulnerability Assessment: The CARVER + Shock Technique
CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.
Inside FDA's Proposed Program To Establish Voluntary Quality Standards
The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality.
What Should You Do After An FDA Inspection?
The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.