PharmOut can supply a range of GMP contractors at short notice. If you need an extra pair of hands to complete a specific job or even several contractors to support a major project, we can help you by providing some of our well trained and experienced GMP professionals.
Typical GMP Contractors Requested:
If you need to replace an engineering staff member who is on leave or if you need extra engineering resources for a major project, we can provide contract GMP engineers with extensive experience working in GMP facilities.
Our technical writers are carefully recruited so that we’re not only providing you with an experienced technical writer but also one who is able to provide broad GMP consulting across a range of subjects.
PharmOut offers a wide range of practical and effective training courses that covers GLP, GMP and GDP. These can be delivered either at your site or at a nominated location. We also offer a range of online training courses too.
If you need someone to replace a QA staff member who is on leave or to support remediation efforts after an audit or even extra QA resources for a major project, we can provide experienced Quality Assurance contractors.
When you need hands on deck to do the work associated with validating your processes, equipment and systems, PharmOut has many capable and professional validation contractors accustomed to working to PIC/S, TGA and FDA requirements.
There’s an increased emphasis by regulators on the GMP temperature mapping of any controlled temperature storage. PharmOut has the equipment and experienced professionals to help you achieve compliance in this area.
Typically, GMP contractors are used as a skilled pair of hands to actually get tasks done. If you need higher level advice on the best way to proceed in terms of GMP compliance or need strategic help on a health/pharma/medical device project then you’ll need a GMP consultant.
Our GMP contractors can work either at your site or remotely in the PharmOut offices. They’ll have the whole PharmOut team of experts as backup for your project. If there’s a problem they can’t solve they can quickly tap the vast expertise of the consultants they work with (and they might even ask the Big Boss, Trev!). You’ll be getting so much more than a single contractor working on your project.
One of the other advantages of a PharmOut GMP contractor is their experience from a multitude of other companies. Instead of being limited to only the experience you and your team have had in different organisations, PharmOut contractors have worked at a large number of companies, both in Australia and overseas. In each company they see processes and ideas that work well…and those that don’t. They can advise you from making the same mistakes they’ve observed elsewhere and can also suggest tried and tested ideas you may not have previously considered.
Here’s a typical scenario of how our customers use our GMP contractors:
Company X had a visit from a TGA auditor and he found a few things that need to be fixed. With everything else that is going on, they were finding it hard to gather the resources needed to get the outstanding audit findings sorted out. They called PharmOut, desperate to get some skilled hands on deck to help them. We sent them three GMP contractors – each with different skill sets, based on what was needed to get the problems fixed. One helped with documentation for 6 weeks. The other two fixed the validation problems the auditor had identified. Each worked for only as long as they were needed, which kept costs under control. They were able to suggest other improvements to streamline compliance activities, based on their experience from other sites. This added real value to the project.