PharmOut is a professional pharmaceutical engineering consultancy offering engineering design and project management services to the pharmaceutical, biotechnology, veterinary and medical device industries. We always try start with the pharmaceutical engineering process design and then wrap the building around the process instead of shoe-horning a process into a suboptimal building.
Our Services Include:
PharmOut offers GMP project management services to help you get up and running while complying 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.
If you already have a design for your facility, our GMP Engineers can review it for GMP compliance as well as ensuring that your plant is designed for current manufacturing best practices such as Economic Batch Quantities (EBQ), optimal work flows, Lean Manufacturing and World Class Manufacturing.
We routinely assist with the selection and awarding of contracts to clean room builders used in the manufacture of drugs and devices and have a wealth of experience in non-sterile and sterile facility design.
We can offer Validation Consultants and/or Validation Contractors to support you throughout the validation life cycle projects. They will use a risk-based approach to focus scarce resources only on what needs to be validated to ensure product quality and patient safety.
Expertise on Offer: A Complete Project Solution
PharmOut offers a complete one stop project solution and can supply a variety of experienced professionals from technical writers and engineers all the way to project managers. These services can be offered on a fixed price basis, hourly rates or as outsourced professionals on your site.
PharmOut uses a ‘staged’ approach to execute and design projects which allows delivery of controlled and cost effective solutions to clients. At the end of each stage, the project goes through a “gate” where it is challenged and a decision on whether to proceed is made. This staged approach allows PharmOut to either provide clients the full project package, i.e. from stage 1 to 6, or individual project stages as required, giving the client flexibility and knowledge of what services are being provided.
Where stages are combined or omitted, the activities and deliverables are reviewed to ensure all essential tasks are still incorporated into the project. The specific approach for each project including deliverables should be documented in the Project Execution Plan (PEP) or proposal. This methodology applies the concept of “front-end loading” which refers to an increased extent of effort expended at the start of a project to initiate, define and scope the project. Projects which have good front-end loading and use a disciplined stage gate process achieve quality, schedule, cost and risk management advantages.
This approach is based on ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry.
Our Engineering Process
The six stages of a PharmOut engineering and design project
The feasibility and conceptual development stages are often combined into what is known at PharmOut as a front end engineering design (FEED) study.
A FEED study is performed to to make ensure:
- the project makes sense once all factors are considered
- the project has a potential viable business case
- information is provided about potential design options
- the scope of the project is defined
- the estimated cost is determined (±30%)
- there are enough resources available to meet a client’s requirements for the facility.
The client will then be able to make informed decisions about the project and how to proceed.
After the feasibility study we do an initial engineering concept design, starting with your product and market requirements, documented in a User Requirements Specification. Our pharmaceutical engineers are well versed in equipment selection, the advantages and disadvantages of certain technologies and, based on our industry experience, we can therefore advise on the best options. We will work closely with your team to develop the most appropriate facility design based on your process requirements while also achieving GMP compliance.
Our complete GMP compliance, engineering and validation service will ensure a high level of confidence that the correct GMP target / standard is set, engineers design it right and our validation engineers ensure that the project quality control is done properly and GMP certification is assured.
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