Once the implementation of the quality system is completed and validated, and the Manufacturing Plant is authorized, industrial scale production starts, beginning with the commissioning of equipment, scaled and process validations.
Ingelyt can collaborate with the customer from the selection of manufacturing and analytical equipment to commissioning, approval and training in a productive area covering at least these activities:
- Making use of procedures, cleaning, maintenance of manufacturing and analytical equipment
- Performing calibration plans
- Performing scaling production protocols
- Performing protocols and implementation of process validation batches
- Making and implementing protocols for cleaning validation
- Media Protocols fill and definition of sterilization cycles (sterile products)
- Realization of Module 3 on a registration dossier
- Support the launch of new products
- Select suppliers and audit API and excipients
- Advice for Production Management
- Training of operators and technicians
- Support at the start of the plant
- Proposed improvements in production
En INGELYT estamos a la vanguardia y somos pioneros en el sector en cumplir con el Diseño, Implantación y Mantenimiento de Planes y Programas de Prevención y Gestion de Riesgos Legales y Penales (CORPORATE COMPLIANCE)