Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
Quality/GMPs
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Digitalization of QbD Risk Assessments
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
Subjectivity in Quality Risk Management
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Phase-appropriate Compliance for Cell and Gene Therapies
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
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As the pressure to bring drugs to market more quickly increases, companies are faced with the challenge of selecting the most effective cold-chain storage solutions.
High-purity low-endotoxin sugars improve robustness and stability of protein formulation and improve drug product quality.
Efforts to accelerate drug development will alter fee structure and require ready production sites.
A new virus-retentive membrane may be used to filter chemical-defined cell culture media for risk mitigation.
Could grading finished-drug manufacturers on their quality and efficiency lead to greater transparency, improve quality and reduce drug shortages?
FDA and EMA set up new working group on the development of treatments for rare diseases.
Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.
Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.
The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.
The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.
The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.
The agency granted accelerated approval to Sarepta’s controversial DMD treatment, under the condition the company conduct additional studies to demonstrate efficacy.
EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.
The agency has recommended marketing authorization for Ibrance in the European Union.
The agency recommended approval of 11 drugs, including three cancer drugs, in September.
The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.
In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.
Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.
The agency provides a qualified context of use for the biomarker plasma fibrinogen.
FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.
The company voluntarily recalled the product due to detached needles on the syringe in the kit.
Mumbai, the location for its new Indian subsidiary, will also be the site for the company's Uniquity Global Conference on October 6, 2016.
The Indian facility was cited for a range of quality and data integrity violations.
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