Cosmetics GMP Consulting
Cosmetics GMP Consulting
We support compliance with ISO22716, EFfCI and cGMP, from assessing your current state to building systems and embedding them in daily operations.
Who Our Cosmetics GMP Support Is For
We understand how GMP is run at your company through gap analysis, interviews and other means, and identify current issues. For the issues identified, we present a proposal aligned with the goals you are aiming for.
- You want to build a cosmetics GMP system, whether or not you are ISO9001 certified
- You want to move from health food GMP to cosmetics GMP
- You want to raise the level of your existing cosmetics GMP operation
- You want to streamline running ISO9001 and cosmetics GMP in parallel
- You want to obtain EFfCI certification
- You want to be ready for FDA inspections
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01Compare Requirements with Current Operations
We analyze the gaps between the requirements of laws, regulations and guidelines and your current facilities, personnel, quality system and operations.
Based on the gap analysis results, we discuss improvement priorities with you and propose the time, cost and implementation approach required.
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02Implementing and Improving Cosmetics GMP (ISO22716)
We propose the personnel, time and cost needed to implement cosmetics GMP, based on your actual situation.
We provide training to deepen understanding of cosmetics GMP.
We map the gaps against the guideline and support prioritized improvements.
To run ISO9001 and cosmetics GMP more efficiently, we support SOP reviews and related work.
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03Preparing for EFfCI Certification
We support the transition from operating under ISO9001, cosmetics GMP or health food GMP to obtaining EFfCI certification.
We explain the requirements of cosmetics GMP and EFfCI side by side.
We outline the personnel, time and cost needed, and propose a risk-based validation approach.
We support creating a quality document system, from top-level documents to individual SOPs.
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04Moving to cGMP Operation and FDA Inspection Readiness
We analyze the current state of your facilities, personnel, quality system and more, and propose the time, cost and transition plan needed for cGMP operation.
We provide support across validation, documentation, training, supplier auditor development and facility improvement.
Where needed, this can lead on to a mock inspection by a former FDA investigator.
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Making Documents, Training and Facilities Work in Practice
We support the validation you need, including IQ, OQ and PQ, process, analytical method, cleaning and computerized system validation.
We sort out gaps and overlaps in existing documents and build a practical system, from top-level documents to SOPs.
We support training tailored to each role and level of understanding, from new staff to managers.
We support facility improvements such as building extensions, manufacturing equipment, water systems and HVAC systems.
Track Record
PERFORMANCE
Explore the projects we have supported so far.
All Services
SERVICE
For questions or consultations about our services, please call us or use the contact form.
Hours: weekdays 9:00–18:00 (JST)
Contact
CONTACT