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Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage

An early February letter from CDER Director Janet Woodcock to hospital infusion/admixture supplier PharMEDium Services puts compounders and the hospitals they serve on notice that the agency will expect compounded preparations to be linkable to the specific patient using them....

Debate Continues Among Stakeholders on Framework for Regulating Pharmacy Compounding; Legislative Options Reviewed at FDLI Forum

Congress, FDA, and the states, together with a wide mix of other stakeholders, are wrestling with how to define a more viable and coherent model for regulating pharmacy compounding – where the boundaries should be placed between state and federal oversight and what the respective regulatory structures and rules should look like....

India Publishes Guidelines for API Export into the EU Under the FMD

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has released procedures from the country’s Central Drug Standards Control Organization (CDSCO) for how Indian active pharmaceutical ingredient (API) manufacturers can obtain a written confirmation of quality that will be needed to ship their products to the EU. Pharmexcil, which was set up by India’s Ministry of […]

Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States

The State of Massachusetts has closed three more compounding pharmacies in the wake of its ramping up of oversight of those making sterile injectables....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

China Projected to Become Major Global Vaccine Supplier with WHO Imprimatur and Overhauled Regulatory Infrastructure

The World Health Organization (WHO) certification of China’s FDA (SFDA) as a “competent authority,” and the quality regulatory upgrades the WHO imprimatur reflects, have opened the door for China to become a major player in the global marketplace for vaccines, WHO Director-General Margaret Chan said at the 65th World Health Assembly held in late May in Geneva, Switzerland....

FDA GMP Compliance Spotlight Will Remain Centered on Conventional Aseptic Processing

FDA is putting industry on notice that conventional aseptic processing lines not employing isolators or restricted access barrier systems (RABS) will get heightened scrutiny from agency investigators and that a convincing justification will have to be provided for their ability to consistently produce sterile product....

Airport Radiation Screening-Induced Recall Highlights PET Drug GMP Challenges; FDA Releases PET Media Fill Guidance

The challenge and importance of GMP management of positron emission tomography (PET) drug processes is underscored by FDA in a new guidance released in October on PET media fills and exemplified by a recent recall of a prominent PET generator...

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....

Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny

A sharp uptick in the number of sterile product recalls due to glass breakage, defects and delamination have the industry, their glass suppliers, and FDA taking a hard look at the reasons for the increase and what can be done to reverse the trend....
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