Quality Systems

The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.

Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation.

Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.

The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.

AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).

In an Oct. 10, 2019 press release, ChargePoint Technology announced that its smart monitoring system, Verifi, is now available for the biopharma market.

The root cause of NDMA contamination may go well beyond manufacturing problems, to the molecule itself.

FDA and DEA warn four website operators to stop illegally selling opioids.

Climbing out of a reputation hole starts with adopting a quality culture.

A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.

Falsified documents and manipulated test results prompt warnings and investigations.

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Automated, electronic systems for raw materials tracking improve efficiency and prevent mistakes in biopharma manufacturing.

Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.

Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.

AstraZeneca has received a complete response letter from FDA regarding its new drug application for a budesonide/glycopyrronium/formoterol fumarate triple-combination therapy for treating chronic obstructive pulmonary disease.

After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.

The European Commission has approved the first plant-derived cannabis-based medicine for the treatment of seizures in patients suffering from two rare, severe forms of childhood-onset epilepsy.

A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.

The inspections took place at the company’s Charnwood, UK, Craigavon, Northern Ireland, and Audubon, PA, locations.

Regulatory agencies published guidelines to advance drug development, streamline submission processes, and promote biosimilars.

FDA has approved Novo Nordisk’s Rybelsus (semaglutide), a glucagon-like peptide receptor protein treatment in oral tablet form for type 2 diabetes.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion recommending marketing authorization for Bavencio (avelumab) in combination with axitinib for treating kidney cancer.

A request has been made to the CHMP by the executive director of EMA to provide guidance on how to avoid the presence of nitrosamine impurities in human medicines.