177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED

Let's Combinate - Drugs + Devices

A tartalmat a Subhi Saadeh biztosítja. Az összes podcast-tartalmat, beleértve az epizódokat, grafikákat és podcast-leírásokat, közvetlenül a Subhi Saadeh vagy a podcast platform partnere tölti fel és biztosítja. Ha úgy gondolja, hogy valaki az Ön engedélye nélkül használja fel a szerzői joggal védett művét, kövesse az itt leírt folyamatot https://hu.player.fm/legal.

7M ago 10:58

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🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com

🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.

This episode dives into the world of GXPs, the essential guidelines for ensuring quality and safety in pharmaceutical and medical device industries. The host explains various GXPs, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GVP), and Good Automated Manufacturing Practices (GAMP).

Each GXP covers different stages from preclinical research to post-market safety, ensuring that products are produced safely, effectively, and consistently. The episode emphasizes the importance of understanding these regulations to guarantee the delivery of high-quality products to patients.

00:00 Introduction to GXPs

02:06 Understanding Good Manufacturing Practices (GMP)

03:27 Exploring Good Laboratory Practices (GLP)

04:35 The Importance of Good Clinical Practices (GCP)

05:44 Ensuring Safety with Good Distribution Practices (GDP)

06:55 Monitoring with Good Pharmacovigilance Practices (GVP)

07:48 Good Automated Manufacturing Practices (GAMP)

08:45 How GXPs Work Together

10:45 Conclusion and Final Thoughts

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

211 epizódok

#Science #Biology #Subhi Saadeh