GMP & Quality Systems: ISO 22716, EU GMP, and ISO 17025
Gap analysis, audit readiness, and quality system implementation for European manufacturers preparing for regulatory inspections and export certifications.
Care Europe provides GMP gap analysis, quality system implementation, and audit readiness consulting aligned with ISO 22716 (cosmetics GMP), EU pharmaceutical GMP, and ISO 17025 (laboratory accreditation) — ensuring your facility and documentation meet the standards required for EU market access and export.
Good Manufacturing Practice (GMP) compliance is a regulatory prerequisite for placing pharmaceutical, cosmetic, supplement, and parapharmaceutical products on the EU market. But achieving and maintaining GMP compliance requires more than just policy documents — it requires a fully implemented quality management system, trained personnel, and documented processes that withstand regulatory inspection. Care Europe provides practical GMP consulting that closes the gap between your current state and regulatory requirements.
ISO 22716 GMP for Cosmetics
ISO 22716 defines Good Manufacturing Practices for cosmetics and is referenced by EU Cosmetics Regulation 1223/2009 as the standard for cosmetic manufacturing. Care Europe conducts ISO 22716 gap analyses against your current manufacturing processes, identifies non-conformances, and provides a prioritised remediation plan. We develop or review your quality manual, SOPs, batch records, and deviations management procedures. For brands preparing for third-party GMP certification, we provide pre-audit mock inspections and corrective action support.
EU Pharmaceutical GMP and cGMP Alignment
EU pharmaceutical GMP (EudraLex Volume 4) governs the manufacture of medicinal products, including OTC drugs, licensed herbal medicines, and investigational medicinal products. For European manufacturers seeking FDA cGMP equivalence (21 CFR Parts 210/211), Care Europe conducts a cross-regulatory gap analysis comparing EU GMP compliance with FDA cGMP expectations. We identify the specific documentation and process gaps that FDA inspectors frequently cite for EU facilities and prepare corrective actions.
ISO 17025 Quality System for Laboratories
ISO/IEC 17025 is the international standard for laboratory competence. Analytical data from ISO 17025 accredited laboratories carries significantly more regulatory weight in both EU and North American submissions. Care Europe assists contract laboratories and in-house QC labs in implementing ISO 17025 quality systems: method validation documentation, measurement uncertainty assessment, equipment calibration programmes, and internal audit frameworks. We also prepare laboratories for accreditation body assessments.
Services & Methods Included
- ✓ ISO 22716 GMP gap analysis for cosmetics
- ✓ EU pharmaceutical GMP gap analysis (EudraLex Vol. 4)
- ✓ FDA cGMP cross-reference gap analysis (21 CFR 210/211)
- ✓ ISO 17025 quality system implementation
- ✓ SOP development and quality manual writing
- ✓ Batch record design and review
- ✓ Deviations, CAPAs, and change control system design
- ✓ Pre-audit mock GMP inspection
- ✓ Personnel training programme design
- ✓ Supplier qualification and audit support
Regulatory Standards & Compliance
- ISO 22716 (GMP for Cosmetics)
- EudraLex Volume 4 (EU Pharmaceutical GMP)
- FDA 21 CFR Parts 210/211 (cGMP)
- FDA 21 CFR Part 111 (Dietary Supplements GMP)
- ISO/IEC 17025 (Laboratory Competence)
- ICH Q10 (Pharmaceutical Quality System)
Industries We Serve
- Cosmetic Manufacturers
- Pharmaceutical Manufacturers
- Contract Laboratories
- Supplement & Nutraceutical Manufacturers
- Herbal Product Manufacturers
- Contract Manufacturing Organisations (CMOs)
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Get a Free Assessment →Frequently Asked Questions
What is the difference between ISO 22716 and EU pharmaceutical GMP?
ISO 22716 is the GMP standard specifically for cosmetics — it covers personnel, premises, equipment, raw materials, production, finished products, quality control, waste, and subcontracting. EU pharmaceutical GMP (EudraLex Volume 4) is more stringent and covers medicinal products. If you manufacture both cosmetics and licensed medicinal products, you may need to meet both standards. Care Europe assesses which standards apply to your operations and identifies the most efficient path to compliance.
Does ISO 22716 certification guarantee EU market access for cosmetics?
ISO 22716 GMP compliance is required by EU Cosmetics Regulation 1223/2009, but GMP certification is not formally mandated by the regulation — the manufacturer is responsible for maintaining GMP compliance. However, ISO 22716 certification from an accredited certification body provides strong evidence of compliance and is increasingly required by major retailers and distributors. Care Europe helps manufacturers achieve both regulatory compliance and, where desired, formal certification.
How long does a GMP gap analysis take?
A GMP gap analysis for a single facility typically takes 2–4 weeks, including an on-site or remote assessment, document review, and preparation of the gap analysis report with prioritised corrective actions. Larger facilities or multi-site programmes take longer. Care Europe provides a timeline estimate after an initial scoping discussion.
Why brands choose Care Europe for gmp & quality systems
Registered in France
EU regulatory partner with legal standing
Bilingual EN/FR
Reports in English and French
NA–EU Bridge
We understand both regulatory worlds
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