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Achieving GMP Certification for Cleanroom Biolabs: 2025 Step-by-Step Guide
Good Manufacturing Practice (GMP) certification is essential for biolabs producing pharmaceuticals, biologics, or medical devices.
This 2025 guide outlines critical steps to meet evolving global standards like FDA 21 CFR Part 211 and EU Annex 1 (2022).
5 Critical Phases
1. Planning (1-4 Months)
Conduct gap analyses against FDA/EMA/PIC/S standards,Draft QMS framework with CCS focus
2.Infrastructure (3-12 Months)
Install HVAC with hepa filtration (iso 5-8),Qualify utilities (WFI, compressed gases)
3. Validation (6-15 Months)
Execute media fills per Annex 1,Validate cleaning/sterilization processes
4. Pre-Certification (12-18 Months)
Run mock audits with GCC® compliance software,Submit application to regulatory bodies
Core Compliance Foundations
Deiiang™ GCC® modular cleanrooms integrate barrier tech (RABS/isolators) for Annex 1 alignment. Key 2025 priorities:
- Contamination Control Strategy (CCS): Science-based risk mitigation
- Data Integrity: ALCOA+ principles for Electronic records
- Deii® monitoring systems: Real-time particle/environmental tracking
Designed by Deiiang Jason.peng and validated by Deiiang joebo.Wang, these solutions streamline iso class 5-8 compliance.
5.Inspection & Maintenance
Host regulators with full documentation transparency,Implement CAPA via Deiiang™ eQMS platforms;
Post-certification, sustain compliance through continuous monitoring, annual audits, and CCS updates. Partnering with experts like Deiiang™ ensures alignment with 2025’s emphasis on AI-driven contamination control and lifecycle management.
