The Cleaning Validation Process
a.Cleaning Validation Master Plan
b.Review of Cleaning Procedures/ Evaluating Cleaning Processes
c.Project Management
d.Auditing and Assessments of Cleaning Validation Process
e.Product Grouping
f. Defining Acceptance Criteria/ Upper and Lower Control Limits
g.Determining Post Cleaning Equipment Storage times
h.Sampling
i. Analysis of Samples
j. Protocol Execution
k.Summary Report Preparation
l. Ongoing Evaluation of Cleaning
m.      Revalidation Program

Cleaning Validation
CAREERS   |
Cleaning Validation

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:

Preparation for the Cleaning Validation Process
a.Cleaning Cycle Development
b.Procedures for Manual and Automated Cleaning
c.Equipment Area Measurements
d.Categorizing Cleaning Agents, Products, and Methods
e.Determining Sampling Locations
f.Implementing Disposables


Methods Development & Methods Validation
a.Analytical Method Development
b.Recovery Studies
c.Validation of Method

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