All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

Weak Link in the Pharmaceutical Supply Chain

April 2, 2008
By Jim Miller
News
Article
Pharmaceutical TechnologyPharmaceutical Technology-04-02-2008
Volume 32
Issue 4

The recent heparin contamination event calls for a new approach to manage a lengthening pharmaceutical supply chain.

Baxter Healthcare, the US Food and Drug Administration, and the pharmaceutical industry in general got a big dose of bad news in late February, when it was reported that several batches of heparin manufactured and marketed by Baxter (Deerfield, IL) may have caused a large number of adverse events, including some deaths. Additional reports of adverse events associated with heparin were also coming out of Germany, relating to product manufactured by Rotexmedica.

Jim Miller

The heparin problem arose less than four months after the US Government Accountability Office (GAO) presented testimony highlighting the deficiencies in FDA's oversight of foreign drug manufacturers. The active pharmaceutical ingredient in Baxter's heparin was supplied by Changzhou SPL in Changzhou, China, which is partly owned by Scientific Protein Laboratories LLC (Waunakee, WI). GAO noted that FDA "does not know how many foreign establishments are subject to inspection," and that its two principal internal databases counted vastly different numbers of foreign establishments (3000 in one case, 6800 in another). The GAO report estimated that FDA was inspecting only about 7% of foreign establishments deserving inspection each year, meaning it would take more than 13 years to visit each site once. The report noted other problems, including the need to preannounce FDA inspections of foreign facilities and the lack of translators on FDA inspection teams.

In fact, GAO noted, FDA does not have the authority to compel foreign establishments to allow it to inspect their facilities. Further, foreign drug establishments making product for the US market do not have to be inspected every two years, as domestic requirements must be. FDA's authority is currently limited to inspecting imported drugs and preventing their entry into the US. There is now a movement in Congress, backed by the Bush administration, to give FDA more explicit responsibility for imported drugs.

On the supply-chain learning curve

Baxter and SPL's heparin problems, and the difficulties FDA has keeping up with foreign establishment inspections, represent just some of the issues that pharmaceutical companies are likely to encounter as they source key ingredients and intermediates from countries such as China and India. Pharmaceutical supply chains are getting longer and more complex; companies are not only geographically farther from their suppliers, they are transactionally farther as well, because they increasingly depend on their primary suppliers to source intermediates and other inputs used to manufacture the products they are ultimately purchasing. This is a far cry from just a few years ago when vertically integrated pharmaceutical companies controlled much more of the supply chain and manufactured most active ingredients and late-stage intermediates in-house.

The learning curve for complex sourcing relationships has been a long one in most industries, not just pharmaceuticals. Companies that have sought to outsource more of the value chain almost invariably have found that their internal systems are not up to the task and that they must have greater involvement with their suppliers to effectively integrate them into their supply chain. For example, when Boeing developed its new 787 Dreamliner aircraft program, it decided to outsource the production of many of its components to suppliers around the world. Now, it has had to delay delivery of the Dreamliner several times because it failed to effectively integrate those suppliers into its scheduling and engineering systems. In addition, the suppliers have not been able to deliver their components on time and in sufficient quantities. When the automobile companies began seriously outsourcing more than 10 years ago, they found that they had to establish stringent quality standards and specifications and invest in training their suppliers in continuous improvement and quality control practices before they could meet these standards.

Time to blog

The globalization of supply chains is creating new political, logistical, and scientific challenges for the pharmaceutical industry. Establishing inspection programs of foreign establishments, for example, will require agreements with foreign governments to allow FDA to exercise some oversight authority over manufacturers in their countries. That will be especially tricky with countries such as China, where there is no history of mutual recognition and cooperation such as exists with European governments.

There will be technical and scientific issues as well. For instance, while investigating the heparin recall, FDA found that the heparin API supplied by SPL to Baxter contained a heparin-like compound that was not heparin but reacted like heparin in traditional analytical tests. FDA did not immediately establish a causal link between the contaminant and the adverse events but issued guidelines for additional analytical tests to identify the foreign substance.

In fact, comprehensive analytical testing is likely to become a more important link in pharma's global supply chain and in FDA's efforts to maintain the safety of human and animal products. This will become a major opportunity for contract analytical labs, especially the worldwide laboratory networks run by companies such as SGS and Intertek, which already have extensive consumer-testing operations and dozens of facilities around the world. Other contract analytical services providers have been slow to establish operations in India and China but are likely to move more deliberately in the near future.

The explosive growth offshore sourcing by the pharmaceutical industry is a relatively recent phenomenon and is directly related to margin pressures felt by pharmaceutical companies resulting from efforts by governments and health insurance providers worldwide to slow the growth of healthcare expenditures. Offshore sourcing has grown so quickly that it has overwhelmed the systems put in place by industry to maintain product quality and safety, and it has afforded no room for "on-the-job" learning. Regulatory agencies and pharmaceutical companies will have to devote more resources to anticipating potential supply-chain risks and implementing mechanisms to prevent them.

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report, tel. 703.383.4903, fax 703.383.4905, info@pharmsource.comwww.pharmsource.com.

Articles in this issue

Suppositories: The Incomplete Story
i1-505377-1408663385436.jpg
A Transformation in the Making
i1-505365-1408663427499.jpg
Vapors, Venison, and Videos
Inside IPEC-EUROPE: Pharmaceutical Excipients—The View from the EU
i4-505378-1408663381861.gif
Measuring Excipient-Market Growth
Report From: China, May 2008
i2-505372-1408663403514.gif
Weak Link in the Pharmaceutical Supply Chain
Spectrophotometric Determination of Lead
i1-505364-1408663430939.jpg
Message in a Bottle
Tracking the Potential of Excipients
i1-505362-1408663435917.jpg
Coming Down the Pike: Bispecific mABs
Trends: Holograms and Anticounterfeiting
Equipment Hold-Time for Cleaning Validation
Science, Empiricism, and Off-label Use
i4-505465-1408663308187.jpg
Innovations at INTERPHEX
Recent Videos
Behind the Headlines, Episode 17
US tariff rate rising , trade policy , business graph and dollars banknote , tax calculation change | Image Credit: © janews094 - stock.adobe.com
Related Content

Darmstadt, Germany - November 10, 2021: A building at the headquarters of science and technology company Merck KGaA. | Image Credit: © Anne Czichos - stock.adobe.com

Merck KGaA Becomes Strategic Partner in Peregrine Ventures’ Incentive Incubator

Patrick Lavery
May 15th 2025
Article

Merck will have early-stage opportunities to help startups set up for future success in the pharmaceutical and life sciences fields.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Feb 2, 2020 South San Francisco / CA / USA - Genentech headquarters in Silicon Valley; Genentech, Inc., is an American biotechnology corporation which became a subsidiary of Roche in 2009 | Image Credit: © Sundry Photography - stock.adobe.com

Genentech and Roche Expand US Footprint with New North Carolina Manufacturing Facility

Patrick Lavery
May 13th 2025
Article

The proposed $700 million, 700,000-square-foot space will support the companies’ future joint portfolio of next-generation obesity medicines.


Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.


A laboratory technician performing a quality control test on a batch of pharmaceutical tablets, highlighting the importance of ensuring drug safety. | Image Credit: ©MAY -stock.adobe.com

Poor API Quality Threatens a Healthy Supply

Susan Haigney
May 9th 2025
Article

Poor API quality may often lead to delays in production and a shortage of supply.


Image Credit: © Alessandro Grandini - stock.adobe.com

Understanding the Variability in Bioburden Test Results in Biomanufacturing

Naveenganesh Muralidharan
May 7th 2025
Article

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

Related Content

Darmstadt, Germany - November 10, 2021: A building at the headquarters of science and technology company Merck KGaA. | Image Credit: © Anne Czichos - stock.adobe.com

Merck KGaA Becomes Strategic Partner in Peregrine Ventures’ Incentive Incubator

Patrick Lavery
May 15th 2025
Article

Merck will have early-stage opportunities to help startups set up for future success in the pharmaceutical and life sciences fields.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Feb 2, 2020 South San Francisco / CA / USA - Genentech headquarters in Silicon Valley; Genentech, Inc., is an American biotechnology corporation which became a subsidiary of Roche in 2009 | Image Credit: © Sundry Photography - stock.adobe.com

Genentech and Roche Expand US Footprint with New North Carolina Manufacturing Facility

Patrick Lavery
May 13th 2025
Article

The proposed $700 million, 700,000-square-foot space will support the companies’ future joint portfolio of next-generation obesity medicines.


Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.


A laboratory technician performing a quality control test on a batch of pharmaceutical tablets, highlighting the importance of ensuring drug safety. | Image Credit: ©MAY -stock.adobe.com

Poor API Quality Threatens a Healthy Supply

Susan Haigney
May 9th 2025
Article

Poor API quality may often lead to delays in production and a shortage of supply.


Image Credit: © Alessandro Grandini - stock.adobe.com

Understanding the Variability in Bioburden Test Results in Biomanufacturing

Naveenganesh Muralidharan
May 7th 2025
Article

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.