THE REACH OF QUALITY SYSTEMS INTO THE SUPPLY CHAIN is drawing FDA attention as it looks for industry support in assuring ingredient quality in a complex global marketplace. As the regulator/industry relationship evolves, the agency may need to follow the lead of other regulators and review the audit reports and management reviews done by pharmaceutical manufacturers to make sure that their quality systems have the necessary self-assessment and response capabilities. At public forums, FDA and industry ofἀcials are stressing the need for new cooperative approaches and information sharing in the supply chain control effort. The agency’s initiatives include upgrading its database infrastructure and inspection risk-modeling, while a third-party clearinghouse is being proposed to help industry share its experience. Closer international cooperation and harmonization among regulators in their GMP inspection programs is also getting heightened attention as an important risk-management component. A “Step 2” draft of ICH’s quality systems guide-line Q10 – a foundation block for this harmonization – drew favorable industry comment this past fall. Japan has adapted its quality regulatory approach to better accommodate the new Q8-10 paradigm.
CONTENTS:
2……Other Regulators Access Internal Audits
4……Culture Shift Required In Role Change
5……Supplier Control Challenges Systems
6……Global Supply Chain In Focus At CDER
16….U.S. Action Plan Targets Import Safety
16….FDA Overhauling IT Infrastructure
17….International Cooperation Needed
18….IPEC Lends Support On Excipients
20….ICH Q7B For Excipient GMPs?
21….Industry Problem-Sharing Urged
24….Third Party Clearinghouse Suggested
25….Inspection Harmonization Targeted
29….Japan Adapts Quality Program To ICH
30….FDA Tweaks Its GMPs
31….ICH Q10 draft draws Comment
32….CDER Improving data For Risk Models
