Quality Systems

A £520 million investment for manufacturing capacity was announced by Chancellor of the Exchequer, Rachel Reeves, but academic and industry leaders stress the money should be used to train personnel.

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, Technical, Parexel.

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

The report highlights international regulators’ plans for the development and availability of vaccines to prevent and drugs to treat mpox.

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

Various microorganisms, including molds and bacterial spores, were tested on stainless-steel coupons and demonstrated 2–6 log reductions with one-minute wet-contact times.

Substituting a compendial-grade material with a food-grade material is not acceptable, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

The use of artificial intelligence and machine learning has the potential to provide some key benefits; however, there are still significant barriers to the implementation of these advanced technologies.

Regulators, EMA and HMA, have published principles and recommendations on the use of LLMs, which are being increasingly used for daily tasks.

The new mechanism of action targets cholinergic receptors instead of the standard dopamine receptors.

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

Two drugs, Miplyffa (arimoclomol) and Aqneursa (levacetylleucine), have been approved by FDA to treat neurological symptoms associated with Niemann-Pick disease, type C in adults and children.

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

The agency is recommending the extension of the smallpox and mpox vaccine, Imvanex, to adolescents aged 12 to 17.

Contract organizations offer assistance when managing changes to material suppliers during a product’s lifecycle.

The approval of EBGLYSS (lebrikizumab-lbkz) by FDA puts a new biologic treatment for moderate-to-severe atopic dermatitis on the market for patients whose symptoms are not well controlled with topical treatments.

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

Greater collaboration and understanding are needed to ensure the correct grade of excipient is used in drug products.

CDER’s Jonathan Chapman, senior policy advisor, and Takeda’s Paulien Groll, head of Compliance Excellence, discussed how companies can be proactive with their CAPA strategies instead of reactive, at the 2024 PDA/FDA Joint Regulatory Conference.

In this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.

New technologies improve efficiency and remove operator intervention.

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

Qualifying material suppliers is a crucial step in ensuring safe and effective drug products.

Bio/pharma companies should be approaching their decarbonization journey as a strategic business move for the future as industry stakeholders are placing greater value on sustainability.