FDA Issues Rule to Clarify GMP Requirements for Aseptic Processing

Rockville, MD (Dec. 4)-The US Food and Drug Administration issued a rule that clarifies its requirements for current good manufacturing practices (CGMPs) for aseptic processing, water standards, and verifications standards. Notice of the rule was published in Federal Register.

FDA issued the rule as part of a process for amending certain regulations in an incremental approach to modifying GMPs for finished pharmaceuticals. These changes are designed to modernize or clarify some of the CGMP regulations and harmonize some requirements with those of foreign regulators.

Among other changes, the rule deletes the current requirement for adherence to a specific US Environmental Protection Agency water standard and instead simply requires that the plumbing system contain water that is “safe for human consumption.”

The rule also amends several aseptic-processing regulations to clarify requirements and reflect currently accepted practices. In some cases, the rule harmonizes the regulations with international regulatory standards. The revision to Sec. 211.113(b) applies specifically to the validation of aseptic processes. Other recommendations concern various types of processes and operations in addition to aseptic processes.

Comments are due 75 days after the publication of the rule, and the rule will be effective 135 days after publication. If FDA does not receive any significant comments during the comment period, the agency will publish a notice in

Federal Register

105 days after Dec. 4 to confirm the effective date of the rule.