GMP
Regulatory framework for pharmaceutical manufacturing quality controls
EN 1090
EU standard for steel and aluminium structural execution
Quick Verdict
GMP ensures pharmaceutical manufacturing quality globally via preventive controls, while EN 1090 mandates CE marking for EU structural steel/aluminium through FPC and execution classes. Companies adopt GMP for patient safety and market access; EN 1090 for legal EU compliance and liability protection.
GMP
Good Manufacturing Practice (GMP) regulations
Key Features
- Independent quality unit with batch release authority
- Risk-based Quality Risk Management (QRM) principles
- Validated processes and equipment qualification (IQ/OQ/PQ)
- Comprehensive ALCOA+ documentation and data integrity
- Continual improvement via CAPA and internal audits
EN 1090
EN 1090 Execution of steel and aluminium structures
Key Features
- Risk-based Execution Classes (EXC1-EXC4)
- Factory Production Control (FPC) certification
- CE marking for structural components
- Welding quality via ISO 3834 alignment
- Material traceability and NDT requirements
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
GMP Details
What It Is
Good Manufacturing Practice (GMP), including cGMP (21 CFR Parts 210/211), EU GMP (EudraLex Volume 4), and WHO GMP, is a regulatory framework establishing minimum standards for manufacturing controls. Its primary purpose is ensuring products are consistently produced to quality criteria, preventing contamination, mix-ups, and variability via preventive, risk-based approaches like Quality Risk Management (QRM).
Key Components
- Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products)
- Pharmaceutical Quality System (PQS) per ICH Q10 with monitoring, CAPA, change control
- Validation (IQ/OQ/PQ), documentation (ALCOA+), independent quality oversight
- No fixed control count; enforced via inspections, no universal certification but compliance audits
Why Organizations Use It
Mandated for pharmaceuticals/biologics; reduces recalls/liability, ensures market access, builds trust. Strategic benefits: supply reliability, efficiency, continual improvement.
Implementation Overview
Phased: gap analysis, Validation Master Plan, training, qualification, audits. Applies to pharma manufacturers globally; requires ongoing inspections, no central certification.
EN 1090 Details
What It Is
EN 1090 is a harmonized European standard family for the execution of steel and aluminium structures. It provides technical requirements and conformity assessment under the EU Construction Products Regulation (CPR), enabling CE marking for load-bearing components. Its risk-based approach uses Execution Classes (EXC1-EXC4) to scale requirements based on failure consequences, service conditions, and production complexity.
Key Components
- **EN 1090-1Conformity assessment, Factory Production Control (FPC), and Declaration of Performance (DoP).
- **EN 1090-2/-3Technical rules for steel/aluminium, covering materials, welding (ISO 3834 alignment), tolerances, corrosion protection, and inspection/NDT.
- Risk-scaled controls via EXC matrix (CC/SC/PC); certified FPC by Notified Body with ongoing surveillance.
Why Organizations Use It
- Mandatory for EU market access via CE marking.
- Reduces liability, rework, and ensures traceability.
- Builds trust with stakeholders; enables high-risk projects.
Implementation Overview
Phased: gap analysis, FPC design, personnel training, NB certification. Applies to fabricators in construction; 3-12 months typical, with audits.
Key Differences
| Aspect | GMP | EN 1090 |
|---|---|---|
| Scope | Manufacturing controls for pharmaceuticals, biologics, APIs | Execution of steel/aluminium structural components |
| Industry | Pharma, biologics, food, cosmetics globally | Construction, steel/aluminium fabrication in EU/EEA |
| Nature | Regulatory GMP frameworks, regional enforcement | Harmonized standard enabling mandatory CE marking |
| Testing | Process validation, lab controls, internal audits | FPC certification, ITT/ITC, NB surveillance audits |
| Penalties | Warning letters, recalls, market exclusion | CE mark prohibition, fines, market withdrawal |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about GMP and EN 1090
GMP FAQ
EN 1090 FAQ
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