Quality Control/Quality Assurance

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

Dynamic light scattering presents a good analytical technique for testing protein stability.

Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.

Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.

A growing pipeline of gene therapy candidates aimed at treating neurodegenerative diseases has prompted new guidance.

Auditing distribution suppliers provides understanding and documentation of the services performed.

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

Amid the rush for a SARS-CoV-2 vaccine to deal with the COVID-19 pandemic, a robust risk assessment must be conducted, and mitigation strategies applied.

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.

Clear understanding of what exactly the biomolecule entails is essential.

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

The collaboration addresses the need for risk mitigation plans in cell therapies.

A holistic approach to validation and quality assurance is essential.

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

Successful migrations require careful planning to meet business needs and maintain data integrity.

The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

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

Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.

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

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

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

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

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.