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Kwaliteitssystemen

Whereas 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:

• 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
• Risk assessments (e.g. HACCP, FMEA) to determine the adequacy of existing or proposed quality systems
• Development of pharmaceutical quality systems, either as a total integrated package or individually, as needed
• Definition of suitable metrics as a management tool for quality monitoring and improvement programmes
• 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
• Coaching and training of personnel at all levels within the organisation in the principles and practice of quality systems
• Preparing organisations for official Regulatory quality system-based inspections
• 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.