Quality Systems

An integrated approach to the data lifecycle is key to successful digital transformation.

Creating building blocks for good manufacturing practices is essential.

It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

EMA has announced a change of plan for the IDMP.

Pharma loses battle to block price negotiations, but implementation faces many challenges.

A new unitary patent system is due to come into effect in Europe later on this year.

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.

A Post Approval Change (PAC) in size of thermal shipping solution used for transport of product is considered a low risk provided it has been qualified and temperature monitored, and therefore can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.

Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.

The European Union publishes long-awaited changes to Annex 1.

Addition of a testing lab to an existing testing site as a Post Approval Change (PAC) is considered low risk when there is no change to testing procedure, specifications, equipment, and the additional lab is already approved by health authorities for other testing activities. Such PACs should be managed in the Pharmaceutical Quality System (PQS) only rather than requiring prior approval.

NICE has recommended the use of Tavneos (avacopan) in combination with rituximab or cyclophosphamide regimen.

Kapruvia (difelikefalin) has been granted approval by Swissmedic as a treatment for moderate-to-severe pruritis associated with CKD.

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

EMA has accepted the marketing authorization application for an oral fixed-dose combination treatment as an initial treatment for adults with AML.

Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.

The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain.

A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.

The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.

Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.

Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.

Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.

Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.

FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.

FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.

Democrats approve curbs for Medicare plans, but not for commercial drug coverage.