CGMP
Current Good Manufacturing Practice
Achieve pharmaceutical and cosmetics manufacturing compliance with validated processes and complete batch traceability.
VEXPLOR CGMP provides a regulatory-compliant manufacturing execution platform for pharmaceutical, cosmetics, and medical device industries. Enforce validated processes, maintain complete batch records, and ensure compliance with ISO 22716, PIC/S GMP, and FDA 21 CFR Part 211 requirements.
Non-Standard (Before)
Non-Standard (Before)
- Paper batch records with manual calculations and transcription
- Deviation investigations tracked in uncontrolled spreadsheets
- Cleaning validation records maintained in paper binders
- No electronic audit trail for critical manufacturing steps
- Annual product quality reviews compiled manually over weeks
Standardized (After)
Standardized (After)
- Electronic batch records with enforced execution sequences and e-signatures
- Automated deviation workflows with CAPA integration and trending
- Digital cleaning logs with validated calculation and acceptance criteria
- Complete electronic audit trail meeting 21 CFR Part 11 requirements
- Automated APQR generation from production and quality data
CGMP Manufacturing Process
Batch Planning
Create master batch records, verify material availability and equipment qualification status.
Weighing & Dispensing
Controlled material dispensing with identity verification, in-process checks, and yield reconciliation.
Manufacturing
Execute batch instructions with enforced step sequences, critical parameter recording, and in-process controls.
Quality Review
Review batch records, evaluate deviations, and make release/reject decisions with e-signatures.
Release & Distribution
QA batch release, generate CoA, and manage distribution with full traceability.
Key CGMP Capabilities
Electronic Batch Records
Digital MBR/BBR with enforced step execution, calculations, and 21 CFR Part 11 e-signatures.
Deviation Management
Structured deviation capture, investigation, and CAPA integration with regulatory classification.
Cleaning Validation
Manage cleaning procedures, sampling plans, and acceptance criteria with changeover tracking.
Environmental Monitoring
Schedule and track EM sampling, trending, and alert/action level management for clean rooms.
Equipment Qualification
Manage IQ/OQ/PQ protocols, calibration schedules, and maintenance with qualification status tracking.
Annual Product Quality Review
Automated APQR compilation from batch, stability, complaint, and deviation data.
Supplier Qualification
Manage approved supplier list, qualification dossiers, and periodic re-evaluation programs.
Compliance & Standards
ISO 22716
Guidelines on Good Manufacturing Practices for cosmetics production.
PIC/S
Pharmaceutical Inspection Co-operation Scheme for harmonized GMP standards.
CGMP Integration Ecosystem
CGMP integrates with QMS for quality system alignment, MES for production execution, LIMS for analytical testing, and ERP for inventory and cost management.
Why VEXPLOR CGMP
| Traditional | VEXPLOR | |
|---|---|---|
| Validation | 12+ months for system validation | Pre-validated platform with qualification accelerators |
| Batch Records | Paper-based with manual review | Electronic with exception-based review |
| Compliance | Bolt-on compliance features | GMP-by-design with built-in regulatory controls |
| Data Integrity | Relies on procedural controls | ALCOA+ enforced by system architecture |
Validation
Batch Records
Compliance
Data Integrity
Achieve GMP Excellence
Deploy a pre-validated CGMP platform that ensures compliance from day one. Reduce batch record review time by 50%.