Regulatory/GMP Compliance

The agency, in response to an executive order, published a list of essential medicines, medical countermeasures, and critical inputs that should be available at all times in an adequate amount to serve patient needs.

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

Bio/Pharma companies are galvanized to develop COVID-19 therapies under FDA’s acceleration program.

Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

For planned acquisitions or licensing, careful analysis of CMC factors ensures no problem areas are overlooked.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.

Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Best practices to consider when transitioning from research-grade to GMP-grade materials.

Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

The White House issued an executive order Sunday, Sept. 13, 2020 implementing a policy to link payments for medicines provided through Medicare to prices charged in other industrial countries.

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.