Quality Systems

Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.

The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.

The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has issued a drug alert concerning a class 2 medicines recall of paracetamol tablets.

Vida International received an FDA warning letter after an inspection found quality control violations.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.

Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.

FDA’s annual manufacturing report card shows more quality compliance is needed.

CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.

Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.

As part of its work to combat the opioid crisis, the agency is considering fixed-quantity, unit-of-use blister packaging for certain immediate-release opioid analgesics.