FDA Issues Quality Systems Guidance

Rockville, MD (Oct. 2)–The US Food and Drug Administration has issued its final Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations (http://www.fda.gov/cder/guidance/7260fnl.htm).

The 32-page guidance differs little from the draft issued October 4, 2004 (69 FR 59256), although the agency has added “a number of clarifying edits” and updated the references. The FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and Office of Regulatory Affairs (ORA) issued the guidance jointly.

Quality Systems Approach describes the responsibilities of the “quality unit,” which combines the duties of quality control and quality assurance, “ensuring that the various operations associated with all systems are appropriately planned, approved, conducted, and monitored.” The quality unit also is responsible for ensuring that controls are implemented and used; seeing that procedures and specifications are adhered to (at the manufacturer and at any contractors); approving or rejecting incoming materials, in-process materials, and drug products; and reviewing production records and investigating unexplained discrepancies.

The guidance further describes a “Six-System Inspection Model” in which the overarching quality system embodies five overlapping subsystems: production; facilities and equipment; laboratory controls; materials; and packaging-and-labeling.

The bulk of the document outlines the components of the quality-systems model in operation. It offers guidelines for defining management responsibilities, allocation of quality resources, dividing manufacturing duties between the quality unit and the production staff, and reviewing records and evaluating data.

The agency announced the guidance in the Oct. 2 Federal Register (FR 71:90, 57980-57981. DOCID:fr02oc06-79). Written comments on the guidance, Docket No. 2004D-0443, should go to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments may be made online at http://www.fda.gov/dockets/ecomments.