Validating cleaning procedures protein

This topic reflects an area in pharmaceutical, biological and radiopharmaceutical manufacturing that is noted as being important by both the Inspectorate and the pharmaceutical industry.

This guideline has been prepared to provide guidance to inspectors, evaluators and industry in reviewing the issues covered.

validating cleaning procedures protein-35validating cleaning procedures protein-14validating cleaning procedures protein-2validating cleaning procedures protein-59

This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies.4.5 Products which simulate the physicochemical properties of the substance to be removed may be considered for use instead of the substances themselves, when such substances are either toxic or hazardous.4.6 Raw materials sourced from different suppliers may have different physical properties and impurity profiles.Inspectors, evaluators and industry may consider other limits if proposed and documented in accordance with appropriate scientific justification.3.1 The objective of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients, and/or cleaning agents as well as the control of potential microbial contaminants.

Leave a Reply