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Printed By


Bowman Cox

Executive Editor

Washington, DC
Bowman Cox leads Citeline's coverage of pharmaceutical manufacturing. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to manufacturers and their quality organizations. Bowman has followed various energy, environmental and health care sectors, writing news for pharmacists, chemists, engineers, lawyers and other professionals. He has moderated and presented at industry and journalism conferences, and has a background in product development, having helped launch publications, conferences and a journalism association. Bowman has a passion for connecting with professional communities, discovering their truths, telling their stories and helping them learn from each other.

Latest From Bowman Cox

US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

US FDA: Pharmaceutical Distribution Entering DSCSA Compliance ‘Stabilization Period’

Agency officials advise drug supply chain partners what stabilization activities they expect to see during one-year “enforcement discretion” period; industry lawyers advise that anyone found coasting could face discretionary enforcement. More discretion, more guidance in the works, including a final ruling on state preemption.

Distribution Quality

The Quality Lowdown: Problems At Iso-Tex, Centaur, Biocon, Lupin And US Specialty

Hot, humid clean rooms, drug-caked equipment, stuck syringes, iffy contraceptives and iffy GMPs were among the pharmaceutical quality shortcomings that surfaced recently.

Manufacturing Quality

Firms Look To Upgrade Aseptic Processing Lines As EU GMP Annex 1 Revision Takes Effect Globally

Sterile drug manufacturers get one year to comply with most revisions in updated EU, PIC/S and WHO GMP Annex 1 guideline. PDA survey hints at scale of challenge facing firms that still use traditional open filling lines, a practice expected to end under the Annex 1 revisions.

Manufacturing Drug Approval Standards

As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year

Potential distribution hitches could spark shortages of legitimate drugs if the system is not fully ready for package-level tracing requirements, US FDA says in delaying enforcement of the program a decade in the making. Poll shows supply chain partners were making significant progress in preparing for the 27 November deadline.

Distribution Legislation

Many Drug Manufacturing Sites Pay A Stiff Price For Ignoring US FDA Remote Records Requests

The FDA has been import-alerting more and more facilities for failing to respond to its remote records requests, FDA compliance official says. Meanwhile, it appears the agency’s generous exercise of regulatory discretion during the pandemic in cases of serious noncompliance is coming to an end.

Manufacturing Quality
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