Apparatuur
HPCS are able to work with clients to identify, specify and deliver the most appropriate equipment for their pharmaceutical manufacturing needs.
Our experience ranges from delivering individual items of equipment which integrate with their existing manufacturing process (e.g. capacity improvements, eliminating bottlenecks, improving process control and bio burden control etc.) - to delivery of complete manufacturing lines and new processes (i.e. new product introduction, scale-up, product transfer, increased capacity upgrades etc.).
In all cases, we have the experience and in depth regulatory and technical/process knowledge to ensure that the new equipment and processes are fit for their purpose. Applying all of this experience together with the client's existing site and product data delivers increased reliability and regulatory confidence, and significantly reduces ongoing operating costs.
Historically, poor equipment specification and project delivery has been shown to be a major contributing factor to ongoing production costs and downtime. An investment in delivering the equipment in a properly planned and professional manner will pay for itself via:-
- Projects being delivered on time.
- Validation delivered on time with regulatory confidence.
- Improved lifetime / reduced ownership costs via increased uptime and operations suitability.
User Requirements Specification (URS)
Our experienced staff will advise and develop in consultation with clients the real ?User Requirements?, including all of the operations, regulatory and engineering requirements, rather than delivering a ?generic specification?, as is the case with many ?standard? projects. This is the foundation of a successful outcome, and requires the experience, expertise and resources available in depth within HPCS.
Vendor Appraisal
Selecting the right equipment supplier is the next critical stage and is often based upon inadequate information. All vendors have strengths and weaknesses; our experience across the industry allows us to apply our ongoing experience with various vendors to the best effect for your project. Vendor audits will be project-specific, but will also include software validation and development lifecycle audits.
Procurement
The procurement and build management needs to be closely monitored in order to keep the project timescales and quality on track. Progress audits and design reviews at critical stages of procurement and manufacture will maintain the focus on the true project deliverables and minimise unwelcome surprises.
Validation:Design Qualification (DQ) to Performance Qualification (PQ)
Validation planning and considerations throughout the project will minimise the ?end of project rush? to validate. We aim to build as many validation activities into the design and build stage as possible. This again ensures quality is built in, rather than added on, but also minimises the time spent on validation when the equipment is delivered to site, e.g. by building validation activities into Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
Acceptance Testing (FAT and SAT), Installation and Commissioning activities
We produce one integrated plan that covers all activities and therefore ensures that there is no unnecessary duplication in FAT, SAT, IQ and OQ activities, as is often the case. Managing Change Control throughout this period is also a key activity that requires single point accountability, often not delivered by projects when many different contractors are involved.
Control Systems Validation
Our instrumentation and Control Engineers will be involved from the URS stage onwards to assess the requirements for software validation on all system components and control / data acquisition systems. This will include vendor audits, assessments and classification of all software components, traceability matrices and the necessary software validation and maintenance plans.
Because HPCS has the ability to deliver and add value to all of the above activities, we may be typically employed to deliver the complete package. This 'one stop shopping' solution minimises the required involvement from the client's team to all but information and option discussions. Alternatively, HPCS can be called upon to deliver or assist with selected, or even a single integrated part of the overall project.