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FDA Regulations Coming Soon for 3D Printed Medical Devices?

3-D printed products, Additive Manufacturing (AM) as the technical term, are becoming increasingly popular and commonplace when manufacturing medical devices. Examples of 3-D printed devices include implants, surgical instruments, dental restorations, prosthetics, and much more. It’s forecasted that the 3-D…

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Batch Records Defined

All cGMP manufacturers are required to keep Master Batch Records (MBRs) and Batch Production Records (BPRs) in order to comply with FDA regulations. Master Batch Records, also known as Master Manufacturing Formulas, are general manufacturing instructions. Each unique formulation must…

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Are Your Standard Operating Procedures Compliant with GMPs?

Quick question: are your standard operating procedures compliant with GMPs? Interpretation—that elusive mode of perception —is what really drives the degree of actual compliance to regulatory guidelines. Given the general nature of many of these guidelines, the field for interpretation…

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InstantGMP Expedition: GMP in New York

InstantGMP Expedition is off! The InstantGMP team heads to The Empire State July 20th-24th! We are interested in the unique challenges that New York supplement and e-liquid manufacturers face in complying with Good Manufacturing Practices. Let's work together to find…

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