Certifications — Our Quality and Compliance Credentials
Certifications — Our Quality and Compliance Credentials
When you choose a cosmetic manufacturing partner, certifications are not just credentials on a wall — they are the operational commitments that protect your brand, your products, and your customers. Fermic Industrial has maintained an unbroken record of regulatory compliance since our founding in 2000, with formal third-party certification since 2012. Here is what each of our certifications means for your brand.
ISO 22716 — Cosmetics Good Manufacturing Practice (GMP)
ISO 22716 is the international standard for Good Manufacturing Practice (GMP) in the cosmetics industry, published by the International Organization for Standardization. It defines the requirements for production, control, storage, and shipment of cosmetic products — and is recognized as the benchmark quality standard in the EU, the United States (FDA voluntary guidelines), and major Asian markets.
Our certification history
Fermic Industrial has held ISO 22716:2007 certification since 2012. Our certification covers all cosmetic and skincare manufacturing activities carried out at our Chiayi facility, including formulation, filling, packaging, and quality control. It is reviewed and renewed through independent third-party audits on a regular basis.
What this means for your brand
Your products are manufactured in a facility whose processes, equipment, personnel training, and documentation systems have been independently verified to meet international quality standards. This supports your compliance position in regulated markets worldwide — from the EU and UK to Japan, Korea, and the US.
GMP — Good Manufacturing Practice in Practice
GMP compliance at Fermic encompasses a comprehensive set of operational controls that go well beyond the standard certification checklist. The following outlines how our facility applies GMP principles at every stage of production.
Environmental monitoring
Our facility maintains strict monitoring of temperature, humidity, and particulate levels in all critical production areas. Conditions are logged continuously and reviewed against defined limits to ensure a controlled manufacturing environment throughout every batch run.
Personnel and hygiene protocols
All production personnel follow documented gowning and hygiene procedures before entering manufacturing areas. Training records are maintained and reviewed regularly to ensure compliance is consistent across shifts and roles.
Batch traceability
Each batch is assigned a unique lot number with full traceability from raw material receipt through to finished goods shipment. Batch records are retained for the periods required by applicable regulations and are available for audit on request.
In-process and release testing
Our internal QC laboratory performs testing on every batch, including viscosity, pH, fill weight, appearance, and microbial load. Any batch that does not meet release specifications is quarantined and formally investigated before disposition — no exceptions.
PIF — Product Information File (EU Market Access)
The Product Information File (PIF) is a mandatory document package required for every cosmetic product placed on the EU market under Regulation (EC) No 1223/2009. The PIF must be compiled before market launch and held available for inspection by competent authorities for 10 years after the last batch is placed on the market.
What Fermic prepares for you
Fermic Industrial supports PIF preparation as a standard part of our EU-destined OEM projects. We compile the full technical dossier — including product description, manufacturing method, safety assessment data, stability data, and preservative efficacy data — to support your Responsible Person's notification process through the EU's CPNP portal.
What this means for your brand
We remove the regulatory complexity from EU market entry. Whether you are launching in Germany, France, the Netherlands, or across the EEA, our documentation supports a smooth notification process and gives you confidence that your products are fully compliant from day one — without requiring you to build an in-house regulatory function.
No Animal Testing Policy
Fermic Industrial operates a strict no animal testing policy across all product categories and at all stages of product development. We do not conduct, commission, or require animal testing on our formulations, ingredients, or finished products. This policy applies globally and is not market-dependent.
Cruelty-free certification compatibility
For brands seeking to obtain or maintain Leaping Bunny, PETA Beauty Without Bunnies, or equivalent cruelty-free certification, our manufacturing process is compatible with these frameworks. We recommend contacting the relevant certification body directly for guidance on their specific brand application requirements.
Quality Management & Continuous Improvement
Beyond our formal certifications, Fermic maintains an internal quality management culture rooted in continuous improvement. Certification is the floor, not the ceiling — our standards are designed to remain well above the minimum threshold required for renewal.
Academic R&D collaboration
Our ongoing partnership with National Chiayi University keeps our technical team current with advances in cosmetic science, formulation technology, and safety assessment methodology. Research conducted through this collaboration directly informs our internal quality benchmarks and formulation development practices.
Operational investment
We invest in regular equipment calibration, staff training programs, and systematic process review cycles. These activities ensure our manufacturing standards evolve alongside regulatory developments and industry best practices — protecting both our certification status and your brand's long-term compliance position.
FAQ: Common Questions About Our Certifications
- Is ISO 22716 required to sell cosmetics internationally?
ISO 22716 is mandatory for cosmetic manufacturers supplying the EU market and is strongly recommended — or required under national GMP regulations — in many other markets including Japan, Korea, ASEAN, and the Gulf Cooperation Council. Fermic's certification gives your brand a solid compliance foundation across all major export markets. - Do I need a PIF even if I am not selling in the EU yet?
Compiling a PIF-standard technical dossier from the start is good practice regardless of your current market. The documentation process identifies formulation or safety gaps early and makes future EU market entry significantly faster and less costly. - Can Fermic's manufacturing support my cruelty-free brand certification?
Yes. Our no animal testing policy is global and covers all stages of product development. We can provide the manufacturing declarations required by most cruelty-free certification bodies. We recommend confirming the specific documentation requirements directly with your chosen certifier. - How do I verify Fermic's ISO 22716 certification?
We provide a copy of our current ISO 22716 certificate upon request as part of our standard supplier qualification documentation package. Contact us to request our full quality credentials file.
Conclusion
Certifications matter most when they are backed by the operational discipline to sustain them. At Fermic Industrial, our ISO 22716 GMP certification, PIF documentation capability, and no animal testing policy are not marketing positions — they are the result of over two decades of consistent investment in people, processes, and infrastructure.
For brands building a quality-led positioning or entering regulated markets, our credentials provide a verifiable foundation that supports your compliance strategy from day one. Learn more about our GMP-certified factory, explore our private label skincare OEM services, or contact us to request our full quality credentials documentation.