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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....

A Six-fold Increase in Manufacturing Discontinuance Notices Helps FDA Ease Drug Shortages, Agency Reports at House Hearing

FDA has experienced a six-fold increase in notifications of product discontinuance or other problems that could cause a potential prescription drug supply disruption since an executive order and a follow-up agency letter to manufacturers were issued at the end of October....

Genzyme Viral Contamination Lessons Implemented in New Biotech Plant; Virus Control Draws Agency/Industry Dialogue

FDA’s and EMA’s January inspection clearance of Genzyme’s new production facility in Framingham, Massachusetts marks another significant step in the firm’s recovery process from a viral contamination and GMP compliance problems cited in a consent decree....

Ben Venue Plant Shutdown Leads to Critical Drug Shortages

Two drugs contract-manufactured by Ben Venue are now in short supply after the firm voluntarily shut down its Bedford, Ohio plant in November to investigate quality and manufacturing issues highlighted in recent FDA and EMA inspections. Doxil – marketed by New Brunswick, New Jersey-based Johnson & Johnson and used to treat ovarian cancer, multiple myeloma […]

FDA Warning Letter to Chinese API Firm Cites Cross-Contamination Concerns

This news brief is provided as a service to IPQ subscribers.

BLA CMC Problem Areas Include Lack of Transparency in Supplement Cover Letters, FDA Reports

FDA is urging sponsors filing Biologic License Application (BLA) supplements to clearly highlight the significant changes and their scope in the cover letter to expedite the agency review and approval process....

Industry/Regulator Forums Point to Role of Glass Suppliers in Injectable QbD

The complex issues around glass quality and drug product interactions bring into high relief the need for container suppliers to be directly involved in the implementation of quality by design (QbD) for injectables....

Amgen Glass Lamellae Investigation Sheds Light on Biopharma’s Control Challenges and Solutions

Amgen’s extensive investigation into the glass lamellae problems it experienced with Epogen, which has included the development of characterization techniques, narrowing down of causal factors, and evaluation of glass manufacturing processes, sheds new light on biopharma’s glass control challenges and the approaches to addressing them....

USP is Revising its Compendia in Response to Injectable Product Glass Issues and Plastics Usage

The particulate and reactivity issues that have been surfacing involving drugs and biologics in glass containers and the increased interest in polymer alternatives are prompting USP to revise and expand its related compendial standards and guidance....

Breakage and Particle Problems in Glass Vials and Syringes Spurring Industry Interest in Plastics

Breakage and particle problems associated with glass containers and biologic product sensitivities are prompting pharma firms to take a harder look at polymers for their vials and syringes....
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