Regulatory/GMP Compliance

Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.

Compliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

Revolutionary therapies restructure pharmaceutical manufacturing.

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.

The document includes recommendations for the reporting and implementation of changes to container closure system components.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

USP offers strategies to minimize residual impurities in downstream processing.

The construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

Scientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

The updated vaccine will be ready to ship following a positive European Commission review.

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.