The Cleaning Validation Process

The current good manufacturing practices recognize that the cleaning process is a critical issue to assuring product quality. Working in a multi-product facility can be a complex task when developing a cleaning validation process. We can assist with all aspects of cleaning validation from the cleaning validation plan, completion of the protocols, sampling, analyzing samples to the development of methods and methods validation. Some areas we can assist you with are as follows:

Cleaning Validation Master Plan
Review of Cleaning Procedures/ Evaluating Cleaning Processes
Project Management
Auditing and Assessments of Cleaning Validation Process
Product Grouping
Defining Acceptance Criteria/ Upper and Lower Control Limits
Determining Post Cleaning Equipment Storage times
Sampling
Analysis of Samples
Protocol Execution
Summary Report Preparation
Ongoing Evaluation of Cleaning
Revalidation Program



Preparing for the Cleaning Validation Process

Cleaning Cycle Development
Procedures for Manual and Automated Cleaning
Equipment Area Measurements
Categorizing Cleaning Agents, Products, and Methods
Determining Sampling Locations
Implementing Disposables



Methods Development / Validation

Analytical Method Development
Recovery Studies
Validation of Method