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 set forth by a company. This is usually a better round to recieve sound and unbiased feedback and regulated control of a clinical trial.

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 location in conducting these clinical trials due to the cost, about 20-60% if done locally.…[Read more]

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 application of SOPs, safety hazards or even documentation control.

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 updates. Projects that have been started already should be assessed on a case by case basis. A risk analysis should be done to determine if these…[Read more]

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 companies today adhere to these standards regardless of GMPs. this can be a result of the existing framework or maybe this is necessary to keep these…[Read more]

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. Each business/company is different in its manufacturing process and products, so applying a strict set of rules would hinder growth in the industry…[Read more]

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…[Read more]

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 protocols for the entire process.

OQ- I believe the OQ should determine your maximum operational window for two things, the application of the…[Read more]

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 can and successfully argue with and rationalize certain aspects of a complete revalidation, I believe it is always worth mitigating risk and going…[Read more]

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 produced quantities of any specific lot number of 1 time use medical devices or the complete traceability of implants and multi-use medical devices.

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 ensure that a documented test method is available to go hand in hand with any applicable results. This allows the SOP to develop along side the…[Read more]

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 others leave very little room for any sort of deviation. In my experience, the more detail the better since the procedure must be repeatable for any…[Read more]

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 root-cause analysis of these failures indicate that the cause of the problem is indeed the spec, then it is early enough in the life of the product to…[Read more]

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 updated to reflect this. Whether it be a material change, a tolerance adjustment or a simple process parameter update all these are minor (or major!)…[Read more]

I believe the DHF to be more valuable than the dossier. I base this off the fact that the DHF is fully auditable by the FDA. Everything from the customer need, risk analysis, design input and output, drawings and verification and validation. These are very valuable in terms of building a product from start to finish with all the associated files.…[Read more]