Quality/GMPs

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

Experts discuss recent advances in cell viability testing methods in bioreactors.

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

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.