FDA Takes "First Step" in Modernizing CGMPs

Rockville, MD (Sept. 8)-FDA issued a Final Rule titled “Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.” As the “culmination of the first increment of modifications to [CFR] parts 210 and 211,” the rule revises CGMP requirements primarily for aseptic processing, the use of asbestos filters, and the verification of performance operations by a second individual.

Regarding aseptic processing, the rule revises CFR section 211.113(b), which now clarifies that the required written procedures to prevent microbial contamination of sterile drug products must include procedures for the validation of all aseptic processes in addition to sterilization processes. The rule also revises CFR section 211.84(d)(6), requiring that microbiological testing be conducted before the use of each lot of component, drug product, or closure “with potential for microbiological contamination.” CFR section 211.94(c), regarding the depyrogenation process for drug-product containers, and CFR section 211.110(a), regarding bioburden testing of in-process control procedures and materials, are also revised.

The final rule revises CFR section 210.3(b)(6) and 211.72 to eliminate provisions that permitted limited use of asbestos-containing filters during the processing of injectable drug products. The regulations now include the statement “The use of an asbestos-containing filter is prohibited.”

The final rule revises the CGMP regulations regarding “which operations may be performed by automated equipment and verified by a person, rather than one person performing an operation and another person verifying that the operation was correctly performed.” The purpose of the change was to eliminate any misinterpretation that a person was required to repeat by hand all calculations performed by automated equipment. The rule also revises CFR sections 211.101(c) and (d), charge-in of components and containers; 211.103, calculation of yields; 211.182, equipment cleaning and maintenance; and 211.188(b)(11), batch-production and control records.

The rule becomes effective on Dec. 8, 2008. Read the announcement of the final rule in the Federal Register.