Complete guide to creating an efficient cleaning process and a robust CV program

Workshop Overview

Cleaning validation is a set of procedures to establish evidence that cleaning processes for manufacturing equipment prevent product contamination. In the current practice, the process of cleaning validation has become essential for the pharma, biopharma, & life sciences industries. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations as well as prevent cross-contamination of chemical residues or microbes that might affect the safety of the patient in relation to the use of API & and finished drug products.

There are different guidelines issued by different authorities that provide guidance on the requirements for the cleaning process and suggestions on the strategy for Cleaning Validation activities. Global regulatory authorities like the FDA & EMA ensure pharmaceutical companies should follow these defined guidelines while implementing cleaning validation practices. If those regulatory requirements are not fulfilled, companies receive warning letters during audits & inspections. It has become mandatory for all pharma & and biopharma companies to make sure that they are following effective cleaning validation plans & procedures.

There are common but critical issues that are faced during the implementation of cleaning validation practices such as: a) Finding out worst case scenario b) Selecting suitable cleaning agents c) Identifying correct sampling locations d) Determining PDE value & e) Analytical methods & techniques to be used.