FDA Calls for Corporate Commitment and Leadership at PolyCarbon Industries
Just when you think that the FDA has to stick to the script by quoting chapter and verse of CGMPs, they get very progressive and offer straight talk about corporate commitment and leadership. We have reported before that the FDA expects corporate oversight of the Quality Management System. The Johnson & Johnson debacle is just […]
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Compliance Tips For cGMP Inspections
Successfully managing a cGMP inspection begins first with developing a clear cut company plan, which will define the roles and responsibilities of everyone that will be involved in the inspection. Because the FDA can arrive at your company without any prior notification, it is important that you thoroughly, and regularly train and prepare all personnel, […]
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FDA Inspection Wizard – What’s Scary Can Turn Out to Be a Piece of Cake
Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared. An FDA inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and regulatory compliance. Here we […]
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How to Perform a Mock Audit
After you have defined the educational programs and standard operating procedures (SOPs) for government inspections, it is wise to choose several studies to apply to a mock audit. You can base your selection on the criteria established by the FDA and on the type of work your company does; for example, a good option would […]
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What You Need to Know About Vendor Audits
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation. The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more […]
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Avoiding these problems in GLP labs can save you a warning letter
Excerpted from The Journal of GXP Compliance There are recurring themes of observations documented in warning letters that relate directly to laboratory and study management. They are: 1. QA fails to do its job One common finding involves the failure of the quality assurance unit (QAU) to fulfill the require-ments of the GLP regulation. The following […]
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Digital Pen Speeds Data Management, Helps FDA Compliance
Digital Pen Speeds Data Management, Helps FDA Compliance Digital pen technology is an efficient data management solution that offers better operational visibility, enabling manufacturers to react quickly to the production process and respond to issues via immediate data access. Hyla Soft’s FactoryScribe is a lightweight web application built around Anoto digital pen technology. It helps […]
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