Hi All,

Yes, I agree that the ambiguity of GMPs makes it difficult for startup organizations to find the right way to implement them. When I worked in a small organization, We always struggled to understand what should be done. We spent so much money on training and consulting firms to make sure that we understand the regulation correctly and we…[Read more]

Hi All,

This is a very interesting discussion so far. I want to look at this situation from a different prospective. If I am a manufacturer that is looking to buy some parts or equipment from a supplier and I have two suppliers that could produce these parts. If one of these suppliers follows GMPs and the other supplier follows no GMP, I would…[Read more]

Hi All,

This situation is usually handled on a case by case basis. In some cases, when the regulation is changed or updated, guidance documents are issued to explain the timeframe of implementation and the criteria that must be met for devices to be grandfathered into the old regulation. From my experience, if the regulation changes before design…[Read more]

This is a great question, and I am currently experiencing that in my current position. Most of the time, projects that are given the GO decision are executed till commercialization. Most of these projects are usually well planned, budgeted and executed. However, due to unforeseen circumstances, the organization may decide that pursuing such…[Read more]

I agree with all the aforementioned comments that all these roles are crucial for a product manager. The one point that I have to elaborate on is the ability of the product manager to understand the factors that could affect sales. The product manager does not need to only understand those factors and prevent them, but he/she should work around…[Read more]

I have had the privilage to lead the root cause investigations on two recalls in the market. The first recall was regarding a mislabeled lot of product. The lot was inadvertently labeled as a different model number that looks similar. The root cause investigation for this recall indicated that the packaging material for both models were not…[Read more]

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 occur while to ensure that the process is capable of producing an output that meets your inputs. The other example of validation that I encountered…[Read more]

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 qualification may include the following:
– Manual and Technical documentation availability
– filler electrical requirements meets the available plug…[Read more]

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 or test. Some Manufacturers use In-line inspection methods, or visual systems to avoid conducting process validation. Some other manufacturers…[Read more]

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 and responsibilities of each member in this organization. The SOPs provide employees with the required steps to achieve the quality defined in the…[Read more]

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 followed. Each step in the SOP should provide the technician with distinct ques about when to execute the following step. This is the best approach you…[Read more]

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 why we used ECOs in everything even in documentation updates is that we needed to make sure that there is no impact on the product safety,…[Read more]

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 be very helpful until you see actual documents to realize the difference. I will do my best to explain it in an easy way.

– DHF is simply a…[Read more]

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 of the term post-market. Post-Market means after obtaining marketing authorizations from regulatory agencies, not when you actually market the…[Read more]

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 especially changes to the SOPs and work instructions. This in fact is to ensure that knowledge affected by this change have been transferred to the people…[Read more]

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 mistakes that were corrected along the way. In my opinion, the EU regulation was built in a way to guarantee that the design is safe and effective in…[Read more]