Validation Outsourcing

In today's competitive world, many companies are choosing to outsource their validation projects & tasks. Validation Outsourcing allows easy scaling of the validation resources to meet changing business demands, such as a new capital projects or staff shortages.

Most companies have already trimmed the 'fat out of the organisation and are operating with lean departments. When a staff member leaves unexpectedly, critical work is often left undone.

Whilst it is critical to maintain the balance between retaining knowledge of your specific processes and the idiosyncrasies of your technologies, it is important to cross-pollinate between your company and others, to ensure best-in-class practice and cost-effective validation.

In many smaller companies, validation is often assigned to personnel who do not have the time, knowledge or experience to handle them. As a result, staff have to start with a blank page (computer screen) and generate validation protocols and templates from scratch! This is not cost effective.

Most staff know that they have to generate a -

Validation Master Plan,
User Requirements Specification,
IQ, OQ and PQ protocols,
Validation Summary Report.

It would be great for your staff to have access to validation protocol templates for generic equipment, i.e. autoclaves, balances, HPLC, tablet presses, packaging lines. Can staff really make an objective risk assessment, if their experience has only ever been in sterile manufacturing and can they adapt to Solid Oral Dosage requirements? Risk judgement is about understanding the full range of products and applying the appropriate GMP risk assessment.

By providing off-the-shelf protocols and the involvement of an independent risk assessor, validation costs can be dramatically reduced whilst maintaining GMP compliance.

Validation Outsourcing is not limited to small companies. Multi-nationals with large, established validation departments often need to overcome staffing shortages, have their staff trained or obtain independent specialist advice.

Whatever your situation, we can ensure regulatory compliance, enhance your business processes and quality systems, and most importantly, allow you to concentrate on your core business.

Our Validation Outsourcing services include:

Senior staff who can design and implement complete cost-effective validation quality systems.
Health checks of your FDA, TGA GMP-compliant validation activities or a supplier's validation protocols.
Protocol design, control and maintenance.
An intelligent pair of hands to get on with it, under your specific direction.

Why choose PharmOut for your validation outsourcing?

We have a practical, no frills approach to validation.
PharmOut have experienced international consultants, engineers, chemists, programmers, biochemists, with offices throughout the Asia-Pacific region.
Responsive service - we normally can have a trained, competent Validation Engineer / Contractor on your site within 7 days. Often this is a next day service within Australia.
We are flexible on the termination date; we understand that business needs change rapidly, boards cancel projects. Why sit with the idle resource?
If your needs change - you would like to keep someone for a "few more days", or terminate early? No problem! Please just keep us in the loop.
Validation is our business. We stay on top of the latest regulatory developments - reading the regulations so that you don't have to.
Outsourcing validation on an'as needed' basis is more cost-effective than hiring staff, with all the associated oncosts.
We have many clients across the Asia-Pacific region and have learnt what works and what doesn't in terms of validation. We can apply what we've learnt to improve your business.