Validation Consultants

PharmOut offers validation consultants on an hourly or fixed price basis to assist you with your validation projects. We offer a validation consulting company perspective on your validation activities, by keeping abreast of latest industry trends and best practice.

Regulatory Changes

Our validation consultants keep abreast of the regulatory landscape changes, as regulators move to enable continuous improvement, innovation and reduce costs, whilst carefully balancing risk to patient health.

The impact on our industry is, you must know your process a whole lot better before validation begins! It is no longer to acceptable to have reams of paper proving that your process is validated, whilst out on the plant you have a low RFT index!

You might ask why?

Well, we believe that finally some sense is starting to prevail in our industry. With the release of the ICH Q8 'Design Space' concept as well as a number of other recent regulatory changes, we can finally start continuous improvement initiatives and drive through cost reductions.

Design Space

The validation landscape has changed forever. Our old approach to validation will no longer be acceptable. Never again can we hand over several volumes of paper and say, "Yes, it is validated." Whilst we still need to understand and validate within controlled parameters, the new mantra is to now validate within a 'Design Space'!

Social Pressures

Whilse continuous improvement is not a regulatory requirement, there has been significant encouragement from the regulatory authorities for us to adopt a continuous improvement approach.

"Why?" you might ask.

Well, most analysts forecast a doubling of the healthcare expenditure over the next twenty years. At the moment, the healthcare expenditure is enormous with the overall health spending, including long-term care for the elderly, accounting for around 8% of GDP in the 24 OECD countries.

And there is a question mark over how much money will be available in the future, given an expected slowdown in GDP growth as the progressive decline in fertility rates since the late 1960s causes labour supply to expand more slowly.

If this expenditure is going to double it is not surprising that governments are worried.

Source - OECD Health Data 2005

OECD countries are spending record amounts on health, totalling US$3.2 trillion in 2003. More than half of this was accounted for by the United States alone, which devoted a full 15% of its GDP on health spending.

Our Validation Consultants offer:

Our Validation Consultants will help you set up a sound, practical approach to your validation efforts. Our expertise will ensure that critical parameters that impact product quality are considered during this development process and allow you to register a design space. This allows for optimisation and continuous improvement during the life cycle of the product.

Source - FDA

Design space: The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post-approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval.