Validation Resources Blog

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"

When a Deviation is encountered during a Validation, it is important that cool heads prevail. Many times I have witnessed frenzied activity which had no value and did not help resolve the Deviations. First of all, the Deviation Procedure should be consulted, take a step back and fully assess the situation. Below are 6 points worth noting when you encounter a Deviation.

No. 1 Provide all the Details

A lack of detail is every Auditors dream! The very first aim of a Deviation is to describe the deviation event. The “Five W's” (who, what, where, when, why) are always a helpful start when writing the description. Remember that providing all the detail will help to ensure traceability if there is a need to re-visit a Deviation in the future.

No. 2 Assess the Impact on Patient and Product

It is best practice to address the impact of the Deviation on both the product (if being manufactured or tested) and the end user or patient. A simple statement such as “there is no impact on the product as the deviation is limited to an ergonomic issue relating to the operator position" can suffice. Likewise a statement such as “there is no impact or risk to the patient as all product will be destroyed per SOP XYZ on completion of this validation”.

No. 3 Avoid Gaps in Supporting Information

It is very hard to close a deviation if test results or supporting data is misplaced. Always ensure data is captured in a timely manner. Attachments should be annotated as per GDP.

No. 4 Approval

Time is money and it is sometimes very tempting to move forward without stopping to think about the correct actions required to resolve a deviation. When the deviation is properly described, investigated and its impact properly understood, agreement on how to move forward and resolve the deviation should be collectively decided and documented. Typically Quality approval is required for the planned resolution in advance of completing the tasks required.

No. 5 Don’t Forget the Basics- GDP

Remember to follow GDP when signing and dating any document or attachment. If you spot an error, point it out to the person responsible.

No. 6 It’s not over till it’s over

Remember that the planned resolution of a deviation should be completed and verified prior to a deviation closure. All testing should be completed and documented accordingly. It is also best practice not to leave final approval linger. If it can be closed, close it. It simply may be forgotten if put on the long finger.