Ensuring manufacturers meet stringent production and quality control standards for pharmaceutical-grade compounds, reducing contamination and improving reliability.
pcGMP-12114 – Nutraceutical-Grade Manufacturing Compliance
Certification Overview
The pcGMP-12114 certification ensures nutraceutical-grade compliance for manufacturers handling peptides, biologics, and advanced formulations. This certification, developed by ISOau, establishes proprietary quality benchmarks aligned with global manufacturing standards.
Who Can Apply?
- Nutraceutical and peptide manufacturers
- Biotech R&D companies
- Contract manufacturing organizations (CMOs)
- Formulation & compounding labs
Compliance Criteria
- GMP-aligned cleanroom conditions
- Batch-to-batch consistency and traceability
- Advanced contamination prevention protocols
- Aligned with global industry best practices, including FDA & EMA guidelines
Benefits of Certification
- Enhances credibility in highly regulated markets
- Increases trust from investors & clients
- Ensures full traceability & manufacturing safety
- Supports compliance with industry expectations
Fees & Processing Time
Application Fee: £100 (Non-refundable)
Audit & Assessment Fee: £1000 (Full review & compliance check)
Annual Surveillance Fee: £150 (Yearly compliance review)
Processing Time: 6-12 weeks
How to Apply
To apply for this certification, visit the Apply for Certification page and complete the application form.