Validation Resources Blog

If you are lucky enough to work in the medical device or pharmaceutical industries, you will probably be familiar with the requirements of Validation, at least to some degree, regardless of your role or responsibilities.

If, like me, you are even luckier enough to be a Validation Engineer, you have likely endured the brunt of resentment that sometimes can be attributed with validation. Validation can be seen to suck time and resources from the goal of production.

For several years now, I have peddled the usual benefits of Validation to whom and where necessary. Just to bore you one final time, the traditionally claimed benefits of Validation include compliance to regulations (a must), benefits to product quality and potential cost savings. However, after taking time to reflect on the goals and spoils of validation, I have developed a new way of thinking about it – here it is!

Communication

Validation forces communication- yes we have morning meetings, team huddles and the like. But validation forces the best form of communication -cross functional roles working together and sharing responsibility. I have been afforded the opportunity to work closely with other Engineers and frequently with operators and technicians.

Big business

A key theme of validation is that of “consistency”. We seek consistent materials, processes and products that meet the requirements of customers while meeting all legal and regulatory conditions. However, as a business grows and particularly, when it expands to more than one site or location, there is an inherent risk of a drift in policy or procedures. Validation keeps this in check and as it is evidence based, it can clearly highlight differences in performance, procedures or the quality of products.

The Little guy

Finally, Small to medium sized companies can benefit from validating their equipment and processes. This can include Engineering companies that provide CNC processing, laser machining and other support to the larger medical device and pharmaceutical companies. Having validated systems is a badge of honor and provides an extra layer of confidence to the customer. If you happen to sell equipment direct to other Med device or pharma companies, having a proven IQ/OQ/PQ template and framework for qualification can make it a very attractive sweetener for regulated companies. Many packaging companies now offer a Validation Pack as a service or add-on. If you are interested in tips and templates, check out our selection online.

Engineers are increasingly seeking employment within  regulated industries such as Life Sciences. Medical Device Manufacturing and Pharmaceutical Manufacturing provide competitive salaries and generally stable employment. For those who aim to cross over from more traditional forms of engineering, the requirements of cGxP may be unfamiliar and daunting at first.

 However, meeting the regulatory requirements is fundamental in allowing the sale and export of products to different markets throughout the globe. Therefore, it is not long before an understanding and competency in cGxP and Validation is required by Engineers, Scientists or Managers.

Now, ValidationResources.org have published  a handbook introducing the concepts of cGxP and Validation. The book is entitled "An Introduction to cGxP and Validation for Engineers"

"An Introduction to cGxP and Validation for Engineers" was written to assist Engineers and Professionals in acquiring the fundamental skills and knowledge needed in Medical Device and Pharmaceutical Companies. 

The book brings together the Key Principles of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Equipment Validation and Process Validation. Case studies based on industry experience are also included, helping the reader to appreciate the practical application of  cGxP and Validation.

Click Here  to see the hardcopy available.

Click Here  to see the Kindle ebook version available at  www.amazon.com  and   www.amazon.co.uk 

Chapter 1- An Introduction to GDP

Chapter 2- An Introduction to GMP

Chapter 3- An Introduction to Test Method Validation

Chapter 4- An  Introduction to Equipment Qualification

Chapter 5- An Introduction to Process Validation

-Case Studies 

Purchase "An Introduction to cGxP and Validation for Engineers"