Good Manufacturing Practice (GMP)
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 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.
OUR SUBJECT MATTER EXPERTS
Ana is a Pharmacist by education with a MSc in Pharmaceutical Sciences from the University of Oporto in Portugal.
AT ADAMAS WE CAN TRAIN EMPLOYEES ON INSPECTION INTERVIEW TECHNIQUES, CONDUCT GAP ANALYSIS ON YOUR SYSTEMS, PROCESSES, OR FACILITIES, FACILITATE FULL MOCK INSPECTIONS AND MORE.
MORE REASONS TO WORK WITH ADAMAS
ADAMAS has conducted thousands of GxP audits in over 100 countries for over 750 international clients. We are committed to providing all our clients with the highest level of service in every country. With offices in three continents, our global capabilities allow ADAMAS to provide coverage for a wide range of healthcare clients, operating internationally.
PUTTING PEOPLE FIRST
ADAMAS has a growing team of full-time, employed permanent consultants, each with an average QA experience of over 10 years, based in three regional offices. With staff based across four continents not only is ADAMAS able to provide coverage for a wide range of clients, we are able to ensure travel for our staff is safe, responsible and practical.
IT AND Infrastructure
ADAMAS partners with the best and most-respected IT suppliers to serve our customers better. We utilize cutting-edge technology including end-to-end encrypted document sharing, ADAMAS audit metrics and benchmarking data so we can provide our clients with efficient and secure service with actionable insights.
YOUR DATA IS SECURE
ADAMAS has comprehensive measures in place to ensure that the data we collect is safeguarded to every extent possible and reflects the ‘state of the art’ GDPR. We also have a number of internal compliance steps to ensure that data is protected from external threats, including independent penetration testing.
WE PARTNER WITH YOUR ORGANIZATION TO CONDUCT FACILITY WALKTHROUGHS TO ASSIST IMPROVEMENTS THROUGHOUT THE COMPANY.
ADJUSTING AUDIT PHILOSOPHY FOR GMP SUCCESS
An in-focus look into the Good Manufacturing Practice (GMP) audit world and how the idea of remote or virtual audits, a fairly new concept is being adopted. In the past, typical audit options included questionnaires, surveys, desk audits, purchase of independent audit reports (i.e. Rx 360), and on-site audits. There were companies looking into the idea of virtual audits but very few. Where are we today?