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Biosimilar Developer May Gain Edge Over Originator on Structure/Function and Process/Product Knowledge, Sandoz Maintains

Sandoz has been making the case in recent public presentations, publications and regulatory guidance comments that companies developing biosimilars may end up knowing more about structure/function and product/process relationships than the companies originating the products they are targeting....

Regulatory Pathways Are Opening Up Globally for Biosimilars

Implementation of biosimilar legislation in India and Brazil, an increase in drug review staff in Japan, and the publication of a draft monograph for monoclonal antibodies to be included in the Chinese pharmacopeia are among the regulatory efforts taking place across the globe that expand the opportunities for biosimilars....

New ISPE CEO Nancy Berg Announces ISPE Mission Refinements

At an ISPE conference on pharmaceutical supply chains in early June in Baltimore, Maryland, new ISPE President and CEO Nancy Berg explained to the attendees that the ISPE board at its meeting the previous weekend made some “subtle, but at the same time very significant changes in the mission of the society.”  Here is what […]

Rx-360 Releases Supply Chain Security Management System White Paper

In mid-April, the supply chain consortium Rx-360 published a “white paper” that describes the concept of a comprehensive supply chain security (SCS) management system.  The goal is to provide a foundation for a maturity model that can drive measurable and sustainable improvement of SCS practices. The paper – created by Rx-360 member company SCS experts – provides industry […]

PIC/S Provides Guidance to Inspectors on Assessing Quality Risk Management

The inter-agency Pharmaceutical Inspection Cooperation Scheme (PIC/S) has released an “Aide-Memoire” intended to assist GMP inspectors in assessing industry’s implementation of quality risk management (QRM) and to help promote a harmonized approach among PIC/S member states....

Role of Drug GMP Compliance Problems in Drug Shortages and Plant Market Devaluation Explored at ISPE Conference

GMP compliance problems at plants producing injectable products not only contribute to drug shortages but can also cause the manufacturing facility with the problems to become devalued and difficult to sell should the firm decide to put the facility on the market, industry experts are cautioning....

Control of Heparin Starting Material Draws Guidance from Both FDA and EMA

Both FDA and EMA have issued guidance for industry focused on the control of the biological starting material, porcine mucosa, used to manufacture heparin, that clarifies testing and supply chain expectations....

NSF-DBA Training Course for Quality Management System Auditors Draws Certification from Britain’s IRCA

NSF-DBA has launched an international training course for pharmaceutical quality management system (QMS) auditors with the certification imprimatur of UK’s International Register of Certificated Auditors (IRCA). The course will deliver certified auditor training covering GMPs and the pharma QMS as outlined in ICH Q10 and is tailored specifically for auditors in the pharma industry that […]

IPEC Announces Launch of EXCiPACT

The International Pharmaceuticals Excipients Council (IPEC) Federation announced in early February the launch of EXCiPACT – its new, voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients. Over 150 stakeholders representing developers, manufacturers, suppliers, distributors, and users of pharmaceutical excipients, […]

GMP Consent Decrees Do Not Delimit Litigation and Financial Risks, Skadden, Arps Partner Stresses at FDLI Conference

Consent decrees provide a resolution between FDA and a pharmaceutical manufacturer of the cGMP compliance commitments and non-conformance penalties but do not forestall other types of litigation and generally have a long tail of related liabilities and financial repercussions, Skadden, Arps, Slate, Meagher & Flom Partner Jennifer Bragg stressed at the annual Food & Drug Law Institute (FDLI) Enforcement, Litigation and Compliance Conference in Washington, D.C. in December....
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