GMP/ISO 13485 Compliance
Let us help you achieve GMP and ISO 13485 compliance.
We can provide a broad range of services from validation protocols to establishing the required documents to meet ISO13485 and QSR compliance.
As part of our services, we can assist you implement the following documentations and systems throughout your facility:
- Raw material testing and control
- Manufacturing SOPs and product history records
- Equipment and facilities validation protocols
- Process validation
- Quality Control procedures and release criteria generation
- Customer complaint handling and recall procedures
- Quality Systems Manual
- Labeling and quarantine SOPs
- Equipment SOPs
- Quality audit procedures
- Design validation and verification
- Sterility validation and verification procedures based on FDA recognized procedures.
We also provide a variety of technical and regulatory services to manufacturers of medical devices, diagnostics, food, cosmetics, and drugs including:
- Documentation for process manufacturing and quality control testing written to comply with QSR/GMP/ISO 13485 and GLP.
- Validation protocols written and performed for processes and equipment.
- Manufacturing process evaluation of drug, biologics, diagnostic reagents and products. Our past experience in manufacturing provides practical assistance in production scale up and process problem-solving.
- GMP and ISO 13485 audits performed to identify areas in which compliance may be weak or lacking. A report is submitted with recommendations for improvement.
- GMP refresher training
For additional information, email frank@fyconsulting.com or call 908-875-7466.