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Honeyman PCS |
Equipment
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 purpose. Applying all of this
experience together with the clients 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:-
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Projects being delivered
on time
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Validation delivered on
time with regulatory confidence
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Improved lifetime / reduced ownership costs via
increased uptime and operations suitability
User Requirements Specification (URS)
Our experienced staff will
advise and develop with clients the real ‘User Requirements’ including all of
the operations, regulatory and engineering requirements, in contrast to delivery
of a ‘generic specification’ like many ‘standard’ projects. This is the
foundation of successful outcome, and requires experience, expertise and
resource found 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
best effect on 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 tracked 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 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. This includes 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 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, trace ability 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 shop’ solution
minimises the required involvement from the clients team to all but information
and option discussions. Alternatively HPCS can be called upon deliver or assist
with just a few, or even one integrated part of the overall project.
Return to GMP Regulatory Compliance Life Cycle |
