#UK #Piramal Pharma #Grangemouth #MHRA GMP

Piramal Pharma Solutions' Grangemouth Facility: A Beacon of Excellence

Piramal Pharma Solutions, a prominent Contract Development and Manufacturing Organization (CDMO), recently celebrated a significant milestone with its Grangemouth facility in the UK receiving updated MHRA GMP certificates. The announcement underscores the facility's commitment to maintaining the highest standards in drug development and manufacturing.

Certificates Overview

These newly updated certificates cover a range of activities conducted within the facility's Helix building, which is dedicated to both clinical and commercial drug substance manufacture and testing. Notably, the certificates also extend to the building's supporting warehouse and laboratory areas, ensuring comprehensive quality control and operational integrity.

The certificates were granted following a detailed submission of an MHRA GMP compliance report, accompanied by a successful desktop inspection by regulatory authorities.

Supporting Clients and Innovation

The Grangemouth site is not only critical in maintaining routine operations but also plays a key role in the development of new therapies. As Piramal's specialized facility for antibody-drug conjugates (ADCs), Grangemouth offers integrated solutions that span from process development through to scale-up. This is particularly vital in supporting the ADCelerate™ program, which aims to accelerate the pathway from research and development to GMP production, ultimately bringing life-saving bioconjugate therapies to patients more quickly.

Peter DeYoung, CEO of Piramal Global Pharma, expressed satisfaction with this achievement, stating, "This underscores the Grangemouth facility's dedication to upholding the highest standards of quality across their operations. With these updated MHRA GMP certificates, we can continue to support our partners in this crucial area of drug development."

Commitment to Quality

The updated MHRA GMP certificates reflect a robust commitment to excellence within the Grangemouth facility, reinforced by an impressive regulatory track record. Over the years, the site has successfully navigated inspections from various international regulatory bodies, including the US FDA, PMDA (the Pharmaceuticals and Medical Devices Agency in Japan), ANVISA (Brazil's National Health Surveillance Agency), the Turkish Ministry of Health, and South Korea's FDA.

The facility's exceptional compliance history and its ability to maintain rigorous quality standards have made it an essential partner in the biopharmaceutical industry.

About Piramal Pharma Solutions

Piramal Pharma Solutions offers a comprehensive array of services throughout the drug life cycle. With a globally integrated network of facilities spread across North America, Europe, and Asia, the company provides an extensive range of services, from drug discovery and process development to clinical trial supplies. Additionally, the firm specializes in the production of highly potent APIs, antibody-drug conjugates, vaccinations, and gene therapies, showcasing its versatility and dedication to pharmaceutical innovation.

With a strong focus on meeting regulatory guidelines and ensuring client satisfaction, Piramal is well-positioned to support the dynamic needs of the pharmaceutical industry, utilizing state-of-the-art technology and lean operational practices.

As it continues to enhance its capabilities, Piramal Pharma remains committed to driving advancements in bioconjugate technology, thereby making significant contributions to global health and improved treatment options.

For more information about Piramal Pharma Solutions and its wide range of services, visit their official website or follow their updates on social media platforms.