Section 246-895-020. Finished pharmaceuticals—Manufacturing practice.

(1) The criteria in WAC 246-895-040 through 246-895-160, inclusive, shall apply in determining whether the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding of a drug conform to or are operated or administered in conformity with current good manufacturing practice to assure that a drug meets the requirements of the act as to safety and has the identity and strength and meets the quality and purity characteristics which it purports or is represented to possess as required by the act.

(2) The regulations in this chapter permit the use of precision automatic, mechanical, or electronic equipment in the production and control of drugs when written inspection and checking policies and procedures are used to assure proper performance.

[Statutory Authority: RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-020, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-020, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-020, filed 10/10/88; Order 133, § 360-46-020, filed 8/4/77.]

RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-020, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-020, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-020, filed 10/10/88; Order 133, § 360-46-020, filed 8/4/77.

Rules

246-895-040,246-895-160,