Using a CRO can usually over an objective assessment to a company when it comes to its drug/device and the resultant outcomes. CROs are usually well versed in conducting and managing clinical trials s...

Cutting costs in clinical trials is a big plus especially for pharma companies that choose to outsource clinical trials overseas. According to the article listed below, India has become a popular loca...

In my experience, a contractor is usually hired or an external auditor is hired for such occasions. This is standard practice if no resources are made available from within the organization.

I think that internal audits can help streamline a business and find problems that perhaps a lax enviornment has perpetuated. Internal audits are more effeicient and can help spot problems in applicat...

I feel that existing product and documentation should be grandfathered in, since the time and money to extend these changes could lead down a many different paths and endless changes, revisions and up...

I feel GMPs purpose is noble, but in practice it is more of a hassle to a company rather than a benefit to a consumer. GMPs can force companies to take the necessary measures, but I feel that most com...

I feel the ambiguity does just that, provide a framework for these companies. Since there is at least a base in place, each company can then place their own quality and SOP in order to comply to GMP's...

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 e...

Hi Viraj, I agree with your approach but I believe you can to the following points: IQ - In addition to the manuals, you should call out maintenance and calibration schedules as well as procedural pro...

I've had similar experiences when moving manufacturing and assembling from one facility to another. Quality will always call for a complete validation for all aspects of the process moving. While you ...

As many have already commented on both DHF and DHR, the FDA actually has some form of DHR database with the new GUDID and UDI initiative. This maintains manufacturing, sterilization, QC as well as pro...

If the product or process is still in a research phase or even development phase an SOP is needed either way. This is to ensure the tests are as repeatable as possible as was stated above and also to ...

Chris, I see this all the time on both ends of the spectrum when reviewing SOPs. There are protocols that lack any clear directions and leave much of the interpretation up to the test engineer while o...

In an failed V&V testing portion of a new product could point to many factors such as poor design, test method, test operators or as you suggested a product simply not able to meet a spec. If a ro...

I believe that the DHF should be a living document. This is due to the fact that many other components of a product may be interlinked. If any part of this product were to change, the DHF should be up...