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

Hussain: Empowering Workers is the Key to Data Integrity

 
• By Bowman Cox

Why would pharmaceutical quality personnel fib about something like a batch test? Ajaz Hussain, the former FDA’er who helped launch the 21st Century Quality Paradigm, may have found the answer in the science of human behavioral economics.

Many Indian pharmaceutical companies need to strengthen their data integrity by changing their quality culture in ways that empower front-line workers, says Ajaz Hussain, an industry consultant, former FDA official and recognized authority on quality who early last year was working for one of India’s troubled drug makers.

During his FDA career, Hussain was a leader in FDA’s 21st Century cGMPs and process analytical technology initiatives, and he...

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

Pakistan Adopts Global PIC/S GMP Guidelines In ‘Landmark Regulatory Reform’

 
• By Vibha Sharma

The Drug Regulatory Authority of Pakistan has adopted a new benchmark for good manufacturing practices, ensuring that the quality and safety of medicines produced in Pakistan meet international standards.

Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff

 
• By Grace Moser

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.

US Strategic Reserve Bulking Up: New Order Focuses On API Stockpile

 
• By Laura Helbling

The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.

EFPIA Rallies EU To Shield Innovative Drugs After US Tariff Cap Is Confirmed 

 
• By Neena Brizmohun

Europe’s research-based pharma industry group, EFPIA, is pressing EU policymakers to protect innovative medicines after the EU-US trade deal confirmed a 15% tariff on pharmaceutical exports. Generic products, meanwhile, have secured an exemption.

More from Compliance

Drug Distributors Face Aug. 27 Deadline For Electronic Exchange Of Product Tracking Data

 
• By Sue Sutter

Compliance deadline comes three months after manufacturers were required to start sending accurate, electronic product tracking data to distributors. The Healthcare Distribution Alliance said its members are ready and it does not anticipate major supply chain issues.

Results Reporting: UK Registry To Offer More Flexibility Than US-Based ClinicalTrials.gov

 
• By Vibha Sharma

ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.

Lilly’s Direct-To-Consumer Portal Implicated In Texas Anti-Kickback Suit

 
• By Cathy Kelly

Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.