Chempilots can assist you establishing a tailored quality system
Chempilots’ production activities are typically within regulated markets and vary in product category and stage in the supply chain.
We can adopt to the quality requirements specified by the customer.
A quality agreement will be entered based on discussion with the customer to identify necessary and sufficient quality attributes taking the risk profile into concern. Thereby, the customer will have an integrated and holistic solution that can be readily implemented.
We can implement applicable parts of following quality systems:
- General Quality Management System ISO9001
- Medical Device QMS ISO 13485 and Quality System Regulation/Medical Device GMP FDA 21 CFR Part 820,
- Pharmaceutical excipients GMP (ICH, IPEC, PICS)
As a pre-production activity Chempilots can assist the customer in providing documents for regulatory filing purposes.
Chempilots do not hold any regulatory filing. Quality inspections are typically conducted by the customer’s own organization.