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Piramal Pharma Solutions Secures Updated MHRA GMP Certificates for its Grangemouth Facility

Piramal Pharma Solutions, a prominent global Contract Development and Manufacturing Organization (CDMO), proudly announces the acquisition of updated Medicines and Healthcare products Regulatory Agency (MHRA) Good Manufacturing Practice (GMP) certificates for its facility located in Grangemouth, UK. This achievement comes after a successful submission of a GMP compliance report and a detailed desktop inspection carried out by the regulatory body.

Overview of the Certification Expansion

The updated GMP certificates apply to all activities performed within the Helix building at the Grangemouth site, which includes not only drug substance manufacturing but also comprehensive testing capabilities. These reforms extend to the facility’s supporting laboratory and warehouse operations, thereby ensuring a robust operational framework conducive for advanced drug development.

Peter DeYoung, CEO of Piramal Global Pharma, noted that this accomplishment reflects the facility's ongoing commitment to maintaining high-quality standards throughout its operations. The updated certificates hold validity for three years, showcasing an unwavering dedication to both compliance and excellence.

A Focus on Bioconjugates

Piramal’s Grangemouth site specializes in the development and manufacturing of antibody-drug conjugates (ADCs), providing comprehensive solutions that span from process development to scale-up. The site plays a vital role in the ADCelerate™ program, which is designed to enhance the efficiency of transitioning from research and development to GMP production. This initiative accelerates the introduction of potentially lifesaving bioconjugate therapies to patients, highlighting Piramal’s strategic focus on quality and speed in drug development.

The recent updates are pivotal in ensuring that the Grangemouth facility can continue to support its partners’ projects and compliance needs effectively. With an exceptional track record of regulatory inspections, including successful outcomes from the USFDA, PMDA, ANVISA, the Turkish Ministry of Health, and the South Korean FDA, the site stands as a paragon of compliance and trustworthy production.

Commitment to Quality and Excellence

The updated MHRA GMP certificates represent more than just compliance; they underscore Piramal Pharma Solutions’ steadfast commitment to high-quality production standards. According to Peter DeYoung, this enhancement allows the Grangemouth site to remain a reliable partner for clients in the critical sector of drug development. "Our dedication allows our partners to bring innovative bioconjugate therapies to market with unmatched precision and reliability," he stated.

Piramal Pharma Solutions (PPS) is renowned for providing end-to-end solutions across the pharmaceutical development spectrum. With a globally integrated network of facilities across North America, Europe, and Asia, the company is well-equipped to support drug discovery, process development, clinical trial supplies, and the commercial supply of active pharmaceutical ingredients (APIs) along with finished dosage forms.

Offering A Wide Range of Services

The company’s capabilities extend to specialized services in highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products, and solid oral drug formulations. Furthermore, Piramal is engaged in the biologics sector through collaborations that allow for the development and manufacturing of vaccines and gene therapies, positioning itself as a comprehensive platform for contemporary pharmaceutical challenges.

Looking Ahead

In conclusion, the recent updates in GMP certification are a testament to Piramal Pharma Solutions' unwavering commitment to quality and regulatory excellence. The Grangemouth facility's operational capabilities are aligned with the needs of modern pharmaceutical advancements, supporting a future focused on innovation and enhanced patient outcomes through meticulous adherence to quality standards. As the company moves forward, its Grangemouth facility will be instrumental in the development of cutting-edge bioconjugate therapies, reiterating its role as a leader in the biopharmaceutical manufacturing landscape.

For more information about Piramal Pharma Solutions and their services, visit their official website to discover how they are shaping the future of drug development.