International adoption of risk-based inspection models and more information sharing offer prospects for relief. Although no
one is looking for mutual recognition of inspection decisions by foreign agencies, there is growing interest in bilateral
agreements for sharing inspection information among regulatory authorities. US membership in the Pharmaceutical Inspection
Cooperation Scheme (PIC/S), which is moving forward, could expand acceptance of PIC/S certificates that a plant meets GMP
standards. Foreign regulators could save resources by first examining what inspection report information is available from
PIC/S, from FDA's inspections database, and from an EU database now under development. And, clarification by the World Health
Organization of its recommendations for when plant inspections are needed would be helpful.
Increased reliance on risk management to reduce low-priority oversight by FDA assumes stronger self-regulation and compliance
by industry. Manufacturers with sound GMP compliance histories and corporate-integrity programs may gain some regulatory relief,
especially for low-risk products.
FDA aims to encourage manufacturers to ensure product quality by establishing internal quality-control units, written process-control
procedures, and processes to fully validate operations. Such policies can demonstrate a corporate environment that encourages
compliance with rules and regulations.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,