Quality Systems

USP expresses its support for a consensus-based global approach to the naming of biologics.

FDA report details risk mitigation projects.

Meeting increasing expectations and escalating regulatory requirements to protect patients.

The campaign supports pharmaceutical growth in India and serves to highlight the value proposition that Indian pharmaceuticals present.

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

FDA releases guidance on ANDAs and PASs submissions to help applicants avoid deficiencies.

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses the use of interactive response technologies in investigational product expiry management.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

PDA surveys are designed to evaluate quality metrics practices at member organizations.

Meggle Group Wasserburg has been granted an EXCiPACT certificate.

Chinese healthcare reforms may be a double-edged sword for foreign companies.

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

With a quality-by-design approach, robust processes consistently can help deliver quality product.

FDA demands accurate manufacturing and test information to ensure product quality.

Biopharma manufacturers must reduce risk in their complex supply chains and establish effective monitoring and control systems.

FDA is moving in the right direction in terms of implementing stratification by levels of compliance across pharmaceutical manufacturing sites. However, quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.

Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.

FDA found violations of cGMP at finished-drug manufacturer in India.

Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.

The European system for assessing drugs will be used as a model internationally.

PharmaChk, a portable device being developed to detect substandard medicines, receives $2-million grant.

Biopharma manufacturers must reduce the risk in their complex supply chains

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

The latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.

The US federal Drug Quality and Security Act (DQSA) and more specifically the Drug Supply Chain Security Act (DSCSA), referring to Title II of the law, requires phase-in of requirements to prevent counterfeiting. An expert discusses how companies should be preparing to meet the requirements of the DSCSA.

Quality by design, process analytical technology, and high throughput screening have helped drive progress in pharmaceutical development.

The European Union has developed a system for evaluating, approving and monitoring the safety of medicines that has also encouraged innovation.