Quality Systems

FDA and industry support global framework and collaborations to secure the supply chain.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general council, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.

Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.

Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.

China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.

Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California’s were.

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.

Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

Moses Lake Professional Pharmacy issues recall due to lack of sterility assurance.

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

FDA warns an Arkansas compounding company that it is in violation of the FDCA.

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.

FDA releases a report that analyses why some diseases are lacking treatment options.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

Checkweighers, metal detectors, x-ray inspectors, leak detectors, headspace analyzers, and optical inspection systems for packaging were demonstrated at INTERPHEX 2015.

FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.