A GLOBALLY COORDINATED RESPONSE TO THE DRUG SUPPLY CHAIN PROBLEMS is being called for, as the realization takes hold among the various stakeholders that the only effective and affordable option is a unified effort. The call for collaborative action to better assure pharmaceutical ingredient quality and supply chain integrity has been forcefully sounded at recent regulator/ industry conferences, and momentum for an international consortium is rapidly building. In the wake of the emerging health threats, standard-setting, pharmaceutical and supplier organizations are joining regulatory agencies in the global outreach effort and new cooperative alliances are being forged. Concerned regulators are evaluating more closely how well drug manufacturer quality systems cover the ingredient supply chain, while companies are analyzing where the QA gaps lie and taking action to fill them. USP initiatives on heavy metals and residual solvents highlight the challenges of developing and implementing global standards. A deeper understanding of the true cost of quality is among the factors driving industry to combine resources with regulators and other stakeholders in the search for better control over a global pharmaceutical supply chain. As in the international financial context, the scope of the supply chain problems is heightening the recognition among the various stakeholders that the only effective and affordable option is a unified effort. New unforeseen alliances are being forged to develop, implement and enforce harmonized standards and solutions. Governmental health. customs, law enforcement and commerce agencies, international health organizations and standard setting bodies, pharmaceutical and supplier associations, individual companies and their various subsidiaries and departments, are all looking for new cooperative mechanisms to rationalize their efforts and maximize their resources.
VOICES FROM THE DIALOGUE:
• CDER compliance staffer Friedman on supply chain vulnerabilities (pp. 7–8)
• Amgen’s CAPA response to heparin situation (pp. 11–13)
• FDA officialBernstein on U.S. & WHO anti-counterfeiting efforts (pp. 21–23)
• Parexel consultant Smith comparing FDA and EMEA inspections (pp. 30–32)
• CDER’s Woodcock on industry/regulator roles and global harmonization (pp. 33–35)
CONTENTS:
2……A Call To Action
5……ICH’s Role, Q7B On Excipient GMPs Debated
6……Supply Chain Problem Clearinghouse?
9……Be Realistic About Cost Of Quality
10….Heparin Situation Prompts Amgen CAPA
14….Shift Happens In The Supply Chain
15….Registration/Pedigree Systems Improving
16….Audit Suppliers But Respect Relationship
18….IPEC, FDA Adding to Excipient Guidance
18….DMF Fees, Approval System Proposed
19….Stakeholders Extend Global Reach
24….India And China Draw Regulator Attention
26….Inspection-Sharing Pilots Launched
32….Global Harmonization Vision Needed
35….USP’s Horizon Is Expanding
37….Heavy Metals Present Hard Issues
39….Implementation Of Concern For Solvents
