We have an in depth understanding of local and overseas regulations and standards applicable to manufacture of dietary supplements, functional foods and ingredients and can support clients to enhance staff understanding and commitment to quality.
Regulations and Standards
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Establishing applicable standards and market regulations
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Guidance regarding customer and market expectation
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Review of claims, labelling evidence and supporting data
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Shelf life/stability studies
Product/Food safety systems development gap analysis and implementation
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Applicability of local and international systems including, Codex; FDA ISO, Chinese and other international standards.
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HACCP, Risk assessment and management
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Development gap analysis and implementation of requisite programs
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Product quality strategy and implementation
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Quality system documentation effectiveness organisation and design
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Quality training and competency
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Incident investigation, CAPA and operational quality management
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Auditing and compliance review
Technical Support
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Quality systems management for capital projects and contractors
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Design and management of specialist systems such as HVAC, clean rooms; critical processes and utilities and computerised systems.
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Verification of decontamination, cleaning and sterilisation
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Process analytics, optimisation, verification and process validation
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Supplier and contract manufacture assessment and management
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Development of product and environmental test and monitoring programs
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Continuous improvement and operational quality
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Technical training, staff development ad competency