GMP Project Management to Ensure Regulatory Compliance
There are times companies just don’t have the resources, knowledge or contacts to facilitate effective GMP project management of current or upcoming projects. This could include for example, designing and engineering a new plant, or upgrading of a current plant all the way to developing a validation master plan for current equipment, writing a QMS or starting an extensive audit remediation programme. Project management is already challenging enough on its own without having to account for the difficulties introduced when ISO/ GMP/ GxP regulatory compliance is a critical factor. Meaning, the number of documents required to capture the planned, executed and completed changes tend to skyrocket.
PharmOut can offer GMP project management services that can help you get up and running while still complying with the relevant regulations. Our extensive experience in the veterinary, pharmaceutical, biotechnology and medical device industries will ensure that critical compliance issues are on the project plan. We know that underestimating the required time as well as the validation effort are common project management mistakes and can foresee pitfalls and potential stoppages in a project before they occur.
PharmOut can help you at any point in your project management including:
- Writing the user requirements specification (URS)
- Project planning
- Project management
- Validation & commissioning
- Project post mortem studies
Below are generally accepted industry estimates for the cost of validation depending on the product type as a rough percentage of the total project costs:
Complementary medicines, nutriceuticals : 2 to 3%
Solid Oral Dose, Liquids Ointments and Creams : 5 to 8%
Sterile Manufacture : 10 to 15%
Aseptic Manufacturing : 15 to 20%
Blood & Tissue
Processing facility : 15 to 20%
Class 1 : 2 to 3%
Class 2 : 3 to 5%
Class 3 : 5 to 10%
The above estimates can be significantly affected by the degree of automation.
Project Management with the GAMP V Model
PharmOut consultants use the ‘V’, or the lifecycle model for the validation framework and MS project for project management. The V model is now widely accepted within regulated life science industries as being best practice in validation management.
PharmOut does not supply engineering or trade services. Instead, we will manage the project using your onsite services. Alternatively, we can help with selecting vendors for the various components of the project. Our independence ensures that the best vendor is selected for each part of the project.
PharmOut’s know-how in balancing compliance with the business reality of daily operations is particularly useful when you are facing remediation after an audit.
Rather than simply patch-up the problem areas, a PharmOut’s GMP project management service will ensure that you achieve compliance in a practical way. This means getting all the stakeholders on board and implementing processes and systems that won’t burden the users by being over-complicated.
By using a PharmOut’s GMP project management experience to run your remediation project, you can concentrate on your normal job and be confident that you’ll achieve compliance without creating a quagmire of forms and processes.
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