US EditionPiramal Pharma Solutions Achieves Regulatory Compliance for Nitrosamine Impurities
Piramal Pharma Solutions implemented a multi-step plan including risk assessments and enhanced testing to meet evolving nitrosamine impurity guidelines, ensuring global regulatory compliance.
- Piramal Pharma Solutions announced it completed its journey to compliance with global nitrosamine impurity requirements, with Chief Quality Officer Rashida Najmi calling it a reflection of commitment to patient safety.
- Evolving regulatory standards for nitrosamines require controlling unintended carcinogenic byproducts, prompting companies to adapt operations and implement specialized synthesis and screening work.
- A cross-functional core team authored a Position Paper and led risk assessments, in-house testing, and external laboratory qualification at Ahmedabad and Digwal pharmaceutical development sites.
- All existing Piramal Pharma Limited commercial products currently comply with global nitrosamine requirements, but some customer products remain pending approval and new batches await regulatory alignment.
- Piramal's global network spans facilities in North America, Europe and Asia, and PPL operates 17 global development and manufacturing facilities, positioning the group to meet ongoing regulatory expectations.
35 Articles
35 Articles
Piramal Pharma Solutions Achieves Regulatory Compliance for Nitrosamine Impurities
Piramal Pharma Solutions implemented a robust action plan to address evolving regulatory requirements pertaining to nitrosamine impurities. Through comprehensive risk assessments, confirmatory testing, and control strategies, the Company is ensuring the safety and compliance of its drug substances and drug…
Piramal Pharma Solutions Achieves Regulatory Compliance for Nitrosamine Impurities
Piramal Pharma Solutions implemented a robust action plan to address evolving regulatory requirements pertaining to nitrosamine impurities. Through comprehensive risk assessments, confirmatory testing, and control strategies, the Company is ensuring the safety and compliance of its drug substances and drug…
Piramal Pharma Solutions Achieves Regulatory Compliance for Nitrosamine Impurities
Piramal Pharma Solutions implemented a robust action plan to address evolving regulatory requirements pertaining to nitrosamine impurities. Through comprehensive risk assessments, confirmatory testing, and control strategies, the Company is ensuring the safety and compliance of its drug substances and drug…
Piramal Pharma Solutions Achieves Regulatory Compliance for Nitrosamine Impurities
Piramal Pharma Solutions implemented a robust action plan to address evolving regulatory requirements pertaining to nitrosamine impurities. Through comprehensive risk assessments, confirmatory testing, and control strategies, the Company is ensuring the safety and compliance of its drug substances and drug…
Piramal Pharma Solutions Achieves Regulatory Compliance for Nitrosamine Impurities
Piramal Pharma Solutions implemented a robust action plan to address evolving regulatory requirements pertaining to nitrosamine impurities. Through comprehensive risk assessments, confirmatory testing, and control strategies, the Company is ensuring the safety and compliance of its drug substances and drug…
Piramal Pharma Solutions Achieves Regulatory Compliance for Nitrosamine Impurities
Piramal Pharma Solutions implemented a robust action plan to address evolving regulatory requirements pertaining to nitrosamine impurities. Through comprehensive risk assessments, confirmatory testing, and control strategies, the Company is ensuring the safety and compliance of its drug substances and drug…
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