The US Drug Supply Chain: Safety Must be Paramount - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

The US Drug Supply Chain: Safety Must be Paramount
Holding product and supply-chain security to the highest standards is crucial for the future.

Pharmaceutical Technology
Volume 35, Issue 1, pp. 97-98

Additional monitoring

As drug products are shipped to wholesalers, pharmacies or other intermediaries, the pharmaceutical industry uses multiple controls to mitigate the risk of contamination or adulteration. Careful planning of drug shipments, along with strict supply-chain custody and controls, are part of the logistical operations that provide accountability and oversight of products moving through the supply channels. These judicious controls enable manufacturers to determine any deviation from the predetermined agenda for shipment and custody.

Overlaying these industry efforts is an extra level of protection provided by the FDA through its oversight of raw materials and finished dose suppliers. Although unfortunate events undoubtedly will occur from time to time, FDA's high standards for API and prescription drug production are the most rigorous in the world.

The pharmaceutical industry, including GPhA members, strongly supports FDA's vision of a safe and secure prescription drug supply chain based on transparency and accountability by all persons who handle prescription medicines throughout the supply chain. As the industry continues to expand its global footprint, no shortcuts in drug-product quality or supply-chain security can be allowed. FDA and industry must remain unyielding in their commitment to the delivery of safe and effective medicines to all Americans.

Overall, GPhA is committed to supporting ongoing FDA supply-chain security initiatives as well as voluntary industry efforts such as Rx–360 and other programs to ensure that all products are safe and effective for the consumer.

Bob Billings is vice-president for policy and interim executive director of the Generic Pharmaceutical Association (GPhA).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology,
Click here