Cleanng Validation Protocol for Pharmaceuticals.docVIP

Cleaning Validation Protocol for Pharmaceuticals Introduction The Validation of the Cleaning Procedures is establishing documented evidence that the procedure is effective and capable for removing the contaminants associated with previous products, residues of cleaning agents as well as the control of potential microbial contaminants. The Cleaning Validation is not only ensuring the compliance of the regulatory requirements, but a more important benefit for performing cleaning procedure validation is the identification and the correction of the potential problems which could compromise the safety, efficacy or quality of the subsequent batches of drug product. Objective 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 so that the analytical monitoring may be reduced to a minimum in the routine phase, and to ensure that there is no risk associated with cross-contamination of active ingredients. The objective of Validation of the Cleaning Procedure (SOP No._______________) used for the cleaning of Machine Name (Machine No. ________________) is to prove that the product contact parts of the Machine Name (Machine No. ________________) have been cleaned and that the contamination level (Chemical and Microbial Contaminants) has been reduced below to an acceptable level. To achieve these acceptable levels, cleaning procedure (SOP No._______________) need to be established and validated; sampling and analysis will be carried out for this purpose to assure that the cleaning of Machine complies with specified limits. Cleaning Validation will verify the effectiveness of cleaning procedure. Scope This document on cleaning validation is intended to address special consideration and issues pertaining to validation of cleaning procedure (SOP No._______________) of Machine Name (Machine No. ________________) used for Tablets Compr