I’NI Consulting Good Manufacturing Practice (GMP) experts can work to evaluate systems at your pharmaceutical, biotechnology, or medical device organization or at your vendor sites to determine if the systems in place are sufficient to meet your manufacturing needs and the current regulatory standards. As an extension of your GMP Auditing team, we’re able to conduct audits on your behalf, using your established audit program or the I’NI Consulting process, whichever works best for your needs.

Our GMP experts have experience auditing systems against applicable regulatory and industry standards. Our experts work with you to apply the correct standards based on your needs, the activities or services provided, and the stage of your project. During our evaluations, we can identify areas for improvement or potential compliance risks. We assess a wide range of systems—most notably those used in quality, production, packaging and labeling, materials, laboratories, distribution, and equipment and facilities.