Hi Viraj, you did bring up a good point. Validation can occur at multiple stages along the manufacturing process. Your prospective validation example...

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 littl...

Hi All, I believe that Both the FDA and ISO have established similar requirements when it comes validation. The FDA requires process validation if th...

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

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...

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

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 be...

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 manufact...

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 chan...

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 m...