Meeting 21 CFR-Part 211.67 Standards

Q. What is 21 CFR- Part 211.67? How can Alconox, Inc help pharmaceutical manufacturers meet these requirements?

A. The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published by the Government Printing Office (GPO) in the Federal Register (FR) by the Executive departments and agencies of the Federal Government. The FDA regulatory guidelines specifically for Title 21 CFR-Part 211.67 details the FDA clean standards on Equipment Cleaning and Maintenance. For more details visit The FDA Website HERE.

The Alconox technical support team has developed a guide for cleaning validation to help the pharmaceutical manufacturer meet these standards. The cleaning validation involves residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and finally writing a procedure and training operators. This procedure is used to document acceptable residues three or more times and then establish a rational monitoring program that verifies that the validated state is being maintained.

For additional technical information on cleaning validation, please Download our Pharmaceutical Cleaning Validation References PDF. And if you have a question for our experts about critical cleaning, please visit Ask Alconox.