Hi Viraj, you did bring up a good point. Validation can occur at multiple stages along the manufacturing process. Your prospective validation example is relevant to the kind of validation that should ...

Medical Device manufacturing processes are now heading towards full automation which is a way used by manufacturers to reduce the risk due to human errors. These automated machines and equipment are f...

Hello Everyone, As I am learning more and more about validation (IQ, OQ, and PQ) I came across a question that may be of interest to many of you. We all know that once any changes occurs to the equipm...

Dr. Simon introduced process validation and IQ/OQ/PQ concepts this week. Based on 21 CFR 820.75, if any changes or process deviations occur, the manufacturer shall review and evaluate the process and ...

Hi Andrew, I like the examples you provided for IQ, OQ, PQ for prefilled syringes, but I think that the IQ for a Syringe filling line may be a little different. For example the Installation qualifica...

Hi All, I believe that Both the FDA and ISO have established similar requirements when it comes validation. The FDA requires process validation if the process cannot be fully verified by inspections o...

Hi everyone, As we have learned from this week's simulation, The company's quality management system documentation hierarchy was as follows : Quality Manual, Quality System Procedure, Work Instructio...

HI Luisa, you raised a very good question that concerns many companies. A quality system is the backbone of any organization. it defines the structure of the organization as well as define the roles a...

Hi Chris, I have ran into your situation multiple times. SOPs are supposed to be written in very specific details. It is also supposed to be written in a step-by-step format in order to be easily fol...

Hi All, In my previous job I had to issue ECOs for many purposes including: - SOP Changes/updates - New SOP Release - Process Changes - Product Specification Changes - Documentation Updates The reason...

I have gone through the same process a while back when I first started working with design controls. It was always confusing what is the difference between a DHR and a DHF. Reading definitions may not...

Hi All, I believe all of you have identified so many ways that post market surveillance can be conducted. The main pitfall that I have seen manufacturers fall in most of the time is the understanding...

I am one of the people that believe that DHF is a living document. Any changes to the Device Must be included in the DHF. I also believe that any changes have to go through a design transfer especiall...

The DHF and Technical file are different documents that have the same content. The Technical File is a snapshot in time of the design without giving much consideration to the design history or the mis...

As we all have learned this week from Dr. Simon, If any of the Verification or Validation test cases have failed during the V&V processes, the specifications have to be either reviewed or changed ...