Regulatory/GMP Compliance

Success in combatting the pandemic depends on the ability of manufacturers to quickly and efficiently produce and distribute the huge quantities of vaccines demanded by the United States government and public health organizations around the world.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for medicines regulation in Europe over the next five years.

The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.

The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.

Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

The first public announcement from the Biden-Harris transition team was to name members of a COVID-19 advisory board charged with initiating policies and actions to combat the fast-rising infection rate in the United States.

Opposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies.

Complex manufacturing processes pose challenges for final product inspection needed to ensure product integrity at commercial launch.

Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

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.