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Honeyman PCS |
Quality Systems
Whereas Good Manufacturing Practices (GMPs) have
traditionally been represented as a catalogue of specific requirements intended
to ensure product quality, there has been a growing awareness that a more
systematic, risk-based approach will pay dividends. Although GMPs set minimum
standards only and have always implied a degree of flexibility in
interpretation, their application in today’s highly technical and rapidly
changing environment is continually under review.
Both regulators and industry
now accept that to operate under cGMP compliance, it is essential to have
well-designed, robust quality systems in place which not only address specific
official requirements, but are also tailored to the needs and risks of each
particular organisation. Furthermore, quality systems must be regarded as
dynamic in nature and therefore under continual review. To achieve this, the use
of quality metrics to provide objective data for management feedback purposes is
emerging as a useful tool.
HPCS can provide strategic
and practical support in all aspects of Pharmaceutical Quality Systems to meet
most product, corporate and regulatory requirements. In particular, the
following services can be provided:
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Gap analysis and
benchmarking audits to determine quality system needs in all operational
aspects of pharmaceutical manufacture, analysis, distribution and associated
activities, such as Technical Services, Purchasing, Materials Management and
Logistics
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Risk assessments (e.g.
HACCP, FMEA) to determine the adequacy of existing or proposed quality
systems
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Development of
pharmaceutical quality systems, either as a total integrated package or
individually, as needed
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Definition of suitable
metrics as a management tool for quality monitoring and improvement
programmes
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Support in the practical
implementation (e.g. preparation of Standard Operating Procedures) and
optimisation of quality systems, either on a project basis or through
interim management
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Coaching and training of
personnel at all levels within the organisation in the principles and
practice of quality systems
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Preparing organisations
for official regulatory quality system-based inspections
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Independent inspections
to determine ongoing compliance to in-house, corporate or official quality
system requirements
With its team of scientists,
engineers and IT specialists who have both Regulatory and senior industrial
experience, HPCS is well placed to provide practical, cost-effective solutions
to all quality system needs.
Return to GMP Regulatory Compliance Life Cycle |
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