Keep the old with the new

An important issue for manufacturers is for FDA to retain its current post-approval change policy for legacy products that have extensive historical data about process parameters and little incentive to adopt QbD approaches. FDA acknowledges the need to continue aspects of the existing regulatory scheme to accommodate those manufacturers who choose to continue operating within the current regulatory framework. But it will be a challenge for the agency to implement a modified approach for new products adopting process analytical technology and design-space approaches while retaining current policies for older products with established manufacturing systems.

Policy revisions that rely more on annual reports to present postapproval change information also may warrant re-evaluation of the format and content of these documents. Lengthy descriptions of multiple minor changes could be replaced by an index or listing of these activities, with supporting data available at the plant site for FDA inspection.

Such developments rely heavily on FDA's field force to ensure that a company's internal systems and controls operate as intended. Plant inspectors would assume more responsibility for checking quality systems and production records during periodic inspections.

Proposals to depend more on a manufacturer's quality system as the basis for reduced supplement filing also raise questions about how FDA would evaluate such status. Would regulatory relief apply to an entire company, to a specific product, or to a production platform? But even if FDA looks to industry to monitor quality internally, or on field inspectors to assume more oversight responsibility for ongoing quality assurance, the agency reminds manufacturers that they remain responsible for ensuring product quality, even if they do not have to report a change.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com