Standards
Quality control standards
The recognized international frameworks
Every serious certification in this field is written against the established international frameworks. ISOGA standards are written against them and codify them for the peptide, biotech and nutraceutical field.
| Framework | Domain | What it governs |
|---|---|---|
| ISO 9001:2015 | Quality management systems | The base quality-management framework every serious manufacturer is measured against. |
| ISO 13485:2016 | Medical devices — QMS | Device-grade manufacturing quality for medical devices and delivery systems. |
| ISO/IEC 17025:2017 | Laboratory competence | Testing and calibration laboratory competence — the framework behind every credible certificate of analysis. |
| ISO 22716:2007 | Cosmetics GMP | Good-manufacturing-practice guidelines for cosmetic products. |
| ISO 22000:2018 | Food safety management | The food-safety framework nutraceutical manufacturing aligns to. |
| WHO GMP | Pharmaceutical GMP | The World Health Organization good-manufacturing framework for pharmaceutical products. |
| EU GMP — EudraLex Volume 4 | European GMP | The European framework for medicinal products and active substances. |
| US cGMP — 21 CFR 210/211 & 21 CFR 111 | United States GMP | Finished-pharmaceutical and dietary-supplement GMP for the US market. |
| ICH Q7 | API GMP | Good manufacturing practice for active pharmaceutical ingredients. |
| GDP — 2013/C 343/01 | Good distribution practice | Storage and distribution integrity for medicinal products. |
The ISOGA standards register
Every ISOGA accreditation is issued against a codified standard. These are the standards behind the certifications and diplomas accredited to Panacea Bio Chem and to Mr Bogdan Dicoias — shown in the certificate registry.
| Code | Standard | Class | Scope |
|---|---|---|---|
| ISO-61143 | Injectable Biotech Standards | ISO Certification | Sterility, purity and potency requirements for injectable biotech products. |
| ISO-78512 | Nutraceutical & Bioavailability Standard | ISO Certification | Composition, dissolution and uptake evidence for nutraceutical products. |
| ISO-91721 | International Peptide Standardization (IPS) | ISO Certification | Identity, purity and handling standard for peptide active ingredients. |
| ISO-BD303 | Advanced Bioavailability & Delivery Systems | Innovation Diploma | Delivery-system design and performance for advanced formulations. |
| ISO-NS202 | Certified Biotech & Performance Supplement Specialist | ISO Certification | Professional accreditation for biotech and supplement specialists. |
| ISO-PA101 | Certified Peptide & Anabolic Advisor | ISO Certification | Professional accreditation for peptide and anabolic advisors. |
| ISO-76513 | Biotech Process Automation | Innovation Diploma | Validated automation of biotech manufacturing processes. |
| pcGMP-12114 | Nutraceutical-Grade Manufacturing Compliance | GMP Certification | GMP-aligned manufacture of nutraceutical products. |
| pcGMP-88321 | Peptide and Cosmetic Injectable Safe GMP Certification | GMP Certification | GMP manufacture of injectable peptide and cosmetic products. |
The batch evidence every accredited entity retains
Certified peptide manufacturing stands on analytical proof, not on declarations. These standards define the quality-control evidence every accredited entity must produce and retain for each batch.