Quality Systems

Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.

The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.

The company recalled the tablets due to a packaging error.

The agency published an action plan to nurture innovation and drug development by SMEs.

The company voluntarily recalled one lot of Brilinta 90 mg professional samples because it contained another medicine.

The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.

Approval of breakthrough therapies requires expedited quality assessment.

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

The company was cited for cGMP violations at its Irvine, California facility.

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.

CBER is moving forward with the development and approval of regenerative medicine advanced therapies.

FDA cited the facility for violations of quality management and data integrity CGMPs.

FDA’s new commissioner asks staff for suggestions for fighting the opioid crisis.

The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.

The agency is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

Due to weak penalties and lax enforcement, illicit pharmaceuticals continue to slip into the US, European and global supply chains.

The agency released several new and revised guidance documents regarding product-specific generic drug development.

Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.

Effective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.