Hi Viraj,

it really depends on the equipment or the process you are trying to validate. There are some, for instance if you purchase equipment from a vendor, there are cases were you can validate this equipment as an COTS ( Commercially Off the Shelf) often times a validation package may be purchased and you may just have to bridge the gaps of validation between the manufacturer and your company. If lets say you bought a customized piece of equipment that utilized software, then a computer system validation (CSV) may be needed. I know I have seen CSV's to be very lenghty and tedious, one particular one that I saw was over 100 pages long and it took the individual a few weeks to complete. Based on my experience I have done DQs,IQs,OQs, and PQs. I have not personally done a CSV yet.

Chris

One interesting form of validation I have performed before is surgeon validation as the end user. Working with specialty medical instruments, our clients were the physicians who gave us specifics of each individual instrument or implant. This could range from custom sizes, to longer/short instruments or even something as simple as changing a grip width or orientation for a certain physician. Usually, upon completion of the drawings the only validation required was the surgeon's handwritten approval.
-Tarek

Our validation is done on SOPs, equipment and the assay for the drug. For the assay it is tested a certain amount of times against a standard to make sure it falls within in range. The machines have to be run in a series of custom steps to get them validated as well, along with any SOPs

I haven’t had no experience in this aspect but I did some research on different type of validation and I found that, self-documenting verification method is the traceability matrix. This method is particularly useful when the design input and output are both documents; it also has great utility in software development. In the most common form of the traceability matrix, the input requirements are enumerated in a table, and references are provided to each section in the output documents (or software modules) which address or satisfy each input requirement. The matrix can also be constructed "backwards," listing each feature in the design output and tracing which input requirement bears on that feature. This reverse approach is especially useful for detecting hidden assumptions. Hidden assumptions are dangerous because they often lead to overdesign, adding unnecessary cost and complexity to the design. In other cases, hidden assumptions turn out to be undocumented design input requirements which, once exposed, can be properly tracked and verified.

Hi all,
Even though I still do not have experience in Validation, but I think that a type of Validation could also be Revalidation.
Revalidation means repeating the original validation effort or any part of it, and includes investigative review of existing performance data. This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems. Possible reasons for starting the revalidation process include:
-The transfer of a product from one plant to another.
-Changes to the product, the plant, the manufacturing process, the cleaning process, or other changes that could affect product quality.
-The necessity of periodic checking of the validation results.
-Significant (usually order of magnitude) increase or decrease in batch size.
-Sequential batches that fail to meet product and process specifications.
-The scope of revalidation procedures depends on the extent of the changes and the effect upon the product.

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 is retrospective validation. This type of validation occurs when an incident occur, or the original validation is not valid anymore, therefore the manufacturer have to conduct the validation one more time to close the gap although that equipment or process may still be used.

In my company our process validations include machining validations, welding validations, validation of assembly fixtures, and finishing validations, such as electropolish validations. One of the validations that we always struggle with is welding validation, and this is mainly due to the fact that our weld validation procedures are confusing, poorly defined, and overly stringent. Does anyone have experience with process validations that were very difficult to pass due to a very strict internal company procedure?

Hi srg36, I think implantable orthopedic medical devices is the most highly regulated medical devices in the market. As we learned form the validation process lecture, Validation is to ensure that the medical device meets the user requirements and the intended use, so, for example, validation for a total hip joint replacement requires mechanical testing, which is difficult to pass, because mechanical testing allows the mechanical conditions in the human body to be simulated in the laboratory, also, this test requires to determine the endurance properties of the stem by using a materials testing machine to apply a sinusoidally varying force.

Although I haven’t dealt with a validation process in a work place, the process is very important in determining the effectiveness of the product. There are different types of validation methods; one type being retrospective validation. Retrospective validation is used for established processes. This form of validation cannot be used when a modification has occurred in the product. This is used when processes have not gone proper documentation for the validation process. The validation is being done based on historical data as evidence that the process has been occurring properly and efficiently. This form of validation is not as commonly used nowadays for processes. It is mainly used when there is an audit of a validated process. However, presently prospective validation is used on products when they are created, so retrospective validation is not as likely to be used.

Efficient and proper validation is key for proper functionality. The validation I have seen that very key in certain institutions are testing of every component in terms of material/functional validation, leak functionality, various chemical coating functionality and shelf life. The procedure that it followed is very important, but the proper training of the tester and accountability and record keeping is also very crucial.