Validation and Qualification can be a painful experience, especially when it goes wrong!

 

Usually because the procedure of procuring the sterilizer wasn’t suitable.  

 

If you want to purchase an autoclave where do you start?  You start by creating an Acceptance Criteria within the PQ.  You say, “But isn’t that the last part; what about the Design Qualification; the specification etc.”  Well, they are important, but if you don’t know what acceptance criteria is needed how can you design the sterilization process? See, it’s easy isn’t it - start at the end and work backwards!

 

I have had a lot of experience with sterilizers; right through, from the initial concept to re-qualification studies.  I’ve seen the pitfalls, experienced the pain and pressure.  I can help you right through this process or just during part of it.

 

An area of concern in the industry is the amount of sterilizer validation that seems to take place.  Companies are under cost pressure; one way to ease that pressure is to evaluate a risk based and cost effective approach to sterilizer validation and qualification.  I can help you as I’ve had a lot of experience in this area.

 

I also provide an independent review of validation, qualification and maintenance data, providing appropriate recommendations for improvement, both in activities, analysis, reporting and cycle development.  

 

I have reviewed and developed validation documentation (Design Qualification, User Requirement Technical Specifications, Functional Design Specifications, Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, Performance Qualification) for use in both pharmaceutical and biotechnology companies.  This has often required an ability to negotiate with, and bring on board, a number of functions (e.g. Purchasing, Engineering, Production, Microbiology, Validation as well as Quality).  Where desired by the client, I have co-ordinated Validation and Qualification activities.