Jill Wechsler is BioPharm International's Washington editor.
Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.
Supplier Audit Program Marks Progress
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
New formulations and expanded vaccine production are encouraged.
New identifiers and tracking requirements aim to block illegitimate products.
Accelerated testing and production create challenges in documenting product quality.
FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.
Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.
OGD is under pressure to improve review operations.