1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

Rx-360 Issues Guide On Remote Supplier Audits; CEO Warns They May Take Longer At First

Remote Audits Should Consider Confidentiality Issues

 
• By Joanne S. Eglovitch

Manufacturers should expect that remote audits of suppliers may take longer than onsite ones until they get more familiar with these audits; it is also important to abide by data confidentiality rules and take frequent breaks when conducting these audits, says Rx-360 CEO.

Woman using tablet pc and selecting inspection.
Expect Remote Inspections To Take longer, Says Rx-360 Exec • Source: Shutterstock

Pharmaceutical manufacturers should expect that supplier audits conducted remotely due to the coronavirus pandemic will take longer than traditional onsite audits until there is more familiarity with this mode of auditing, according to Jim Fries, CEO of Rx-360.

Fries was discussing some of the challenges and the best practices for conducting remote audits at a 7 October online seminar sponsored by the Healthcare Distributors Association’s Pharmaceutical Cargo Security...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Manufacturing

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

More from Compliance

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.