Quality Systems

Six years after the guidance, it’s time to change our quality assurance vocabulary.

Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.

The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.

FDA works with industry on strategies for assuring high-quality regenerative medicines.

Forced degradation studies can identify stability problems for drug substance and drug products.

When it comes to getting the best out of quality by design, timing is everything.

EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.

Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.

FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.

A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.

Implementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.

QbD principles and strategic thinking can reduce the time required to optimize formulation. 

Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.

The International Society for Pharmaceutical Engineering announced the release of ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition).

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.

The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.

The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.

A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

The agency published guidance on identifying trading partners under DSCSA.

FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.

CPhI released the findings of the 2017 India Pharma Market Report, which identified a two-tier manufacturing market and forecasted increased acquisitions by Indian companies, along with a significant improvement in the international reputation of Indian-made pharmaceuticals.