GMP Project Management
Managing facility projects to ensure GMP regulatory compliance
There are times companies just don’t have the resources, knowledge or contacts to manage a plant upgrade or construction of a new plant. This is particularly the case when GMP / GLP regulatory compliance is a critical factor.
PharmOut offers GMP project management services to help you get up and running and comply with the relevant regulations. Our extensive experience in the veterinary, pharmaceutical, biological, biotech and medical device industries will ensure that critical compliance issues are on the project plan. Underestimating the required validation effort is another common project management mistake.
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.
PharmOut can help you at any point in your project; including:
- Writing the user requirements specification (URS)
- Project planning
- Project management
- Validation & commissioning
- Project post mortem studies
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 project manager will ensure that you achieve compliance in a practical way. This means getting all the stakeholders onboard and implementing processes and systems that won’t burden the users by being over-complicated.
By using a PharmOut Project Manager 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
To find out more
Contact us to discuss your project.