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Honeyman PCS |
Ongoing Support
'Good Project Delivery' will
significantly reduce and control the ongoing support costs including
maintenance, regulatory compliance and operations effectiveness - production
delivery.
On the other hand, ‘Bad Project
Delivery’ - often the least cost alternative - does exactly the opposite.
It is still vitally important
to plan for ongoing support activities as part of the project.
HPCS Quality
Systems Support will deliver the documented systems for Operation and
Maintenance Procedures and Practices. In addition to this ‘set up’ support we
provide:-
Troubleshooting Support
Our
team of engineers and scientists cover all disciplines required for
pharmaceutical manufacture and process control. Therefore we are well placed to assist in any
troubleshooting activities. Unlike the equipment vendors we can take an holistic
view and identify the root causes of problems rather than just looking for a
quick/temporary fix. We are generally able to get an engineer or technical
specialist to site the next day to assist in times of urgent need.
Change Control and
Continuous Compliance
Changes to processes and
equipment are inevitable during the life of a process, either because of
obsolescence or the need for process/capacity improvements. We can help manage
this change process, assess the requirements, control the work and requalify/revalidate as necessary following the change. Again, our range of technical
expertise and disciplines ensures we have the skills necessary to assess and
manage the change and implications.
Requalification
The need for requalification
may be driven by regulatory changes, site/equipment changes or just loss of
confidence in the process and existing validation. We can both deliver
engineering and technical resource to complete the requalification and also
manage the whole process from definition to documentation and delivery.
Audit and Inspection
We perform a range of audits
from pre inspection readiness audits looking at the overall process and quality
systems, to specific equipment audits targeted at compliance or supportability
in a certain area. The scope of the audit is clearly defined up front with
deliverables agreed. Typical audits include:-
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Equipment / Process Health
checks
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Complete Process Review
for Compliance, Operations, Maintenance and Validation
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Needs Assessment Audits:
Perhaps as a precursor to a project to help define requirements
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Pre Inspection Audits.
These can be targeted at particular regulatory bodies’ requirements
Interim Management
In addition to managing the
projects and work packages that we deliver HPCS provides interim management
resource to help you through particular periods of high workloads and technical
skill shortages. This can sometimes be incorporated as part of a major project
that we are delivering for you, or just a single resource to fit into your
management structure for a period of time.
Return to GMP Regulatory Compliance Life Cycle |
