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Good Manufacturing Practice (GMP)
Assessing your systems
ADAMAS’s 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 ADAMAS process, whichever works best for your needs. Our GMP experts have experience auditing systems against internal government standards (FDA, EU, MHRA, PDMA, to name a few) and industry standards (ISO, ICH, USP, and others as applicable). 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.
Preparing you for inspection
Our GMP expertise means we’re perfectly placed to prepare you for inspections. Offering a wealth of services, we can train employees on inspection interview techniques, conduct GAP analysis on your systems, processes, or facilities, and facilitate full mock inspections and more.
Supporting your processes
ADAMAS can partner with your organization to conduct facility walkthroughs to support process improvements throughout the company. Through support services such as inspection training, gap analysis, or risk assessments, our team can strengthen the compliance of your systems.
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