Quality/GMPs

Mike Hennessy Jr. is the President and CEO of 

Articles

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

The Dislocation of Progress

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

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

FDA Publishes Guidance on Container Closure Systems for COVID-19 

Feliza Mirasol is the science editor for 

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.

Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)

Chris Spivey is the editorial director of 

USP offers strategies to minimize residual impurities in downstream processing.

Paring Down 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).

Gritgen Therapeutics Launches Commercial GMP Facility in China

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

FDA Establishes Pilot Program to Accelerate Rare Disease Therapy Development

Videos

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

Continuous Manufacturing is Here to Stay (PDA/FDA Joint Regulatory Conference 2023)

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.

Highlights of ICH Q13 Session (PDA/FDA Joint Regulatory Conference 2023)

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.

The Impact of Advanced Manufacturing Technology (PDA/FDA Joint Regulatory Conference 2023)

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

Regulatory/GMP Compliance