Good Manufacturing Practices (GMP), are a set of standards and guidelines that ensure products are manufactured with quality, safety, and traceability, minimizing risks of contamination, failures, or deviations.
These practices are required by regulatory bodies such as ANVISA, MAPA, FDA, and ISO for sectors like food, cosmetics, pharmaceuticals, electronics, and medical devices.
GMP is not just a standard: it is culture, responsibility, and commitment to the end consumer.
📋 Fundamental Principles of GMP
| Principle | Objective |
|---|---|
| Hygiene and Cleaning | Prevent cross-contamination and ensure a controlled environment |
| Process Standardization | Ensure repeatability and traceability of production stages |
| Quality Control | Verify raw materials, process, and final product |
| Documentation and Records | Ensure objective evidence and traceability |
| Personnel Training | Train operators to perform tasks safely and accurately |
| System Validation | Confirm that equipment and processes function reliably |
🧪 Applications in Testing and Production Environments
- Validation of test benches (IQ/OQ/PQ)
- Standardized procedures (POP/SOP) with version control
- Tests with traceability (DUT, batch, operator, review)
- Automatic execution and result logs
- Production and laboratory environments with access and cleaning control
🔧 How AJOLLY Testing Supports GMP Implementation
AJOLLY Testing develops technical solutions aligned with Good Manufacturing Practices requirements, ensuring that test equipment and validation systems meet current standards.
🛠️ Validated Test Systems
- Development with full traceability of the DUT
- Generation of automatic and auditable test reports
- IQ/OQ/PQ Validation of test stations according to RDC and FDA
📁 Technical Documentation and Procedures
- Technical manual with risk identification (NR-12, ISO 12100)
- Operational procedures (POP/SOP) with integrated training
- Digital records with electronic signature and access control
📊 Compliance with Standards and Audits
- Alignment with RDC 47/2013, RDC 665/2022, ISO 13485, ISO 9001
- Support in technical audits and implementation of CAPA plans
- Integration with MES, ERP, quality and traceability dashboards
With AJOLLY Testing, GMP becomes more than a regulatory requirement — it transforms into a tool of excellence, safety, and technical confidence.