Wherever APIs are manufactured and distributed, it is the Quality Assurance who is responsible to guarantee and safeguard the product quality and purity. In order to be able to meet this responsibility, API manufacturers are required to operate a comprehensively planned and correctly implemented quality assurance system.
Based on solid know-how and many years of experience in the area of Quality Assurance for APIs, we make sure that Your quality assurance system will be effective and able to stand authority inspections (EU inspections US FDA context) as well as customer audits – sovereignly.
Our services comprise:
- Mock auditing for identification of quality assurance deficiencies and weak points
- Set-up and optimization of quality assurance processes (for example change and CAPA management)
- Preparing new SOPs, harmonization and optimization of existing SOPs as well as consulting and support in SOP implementation
- Preparation for inspections, behavioral inspection training and escorting during authority inspections and customer audits
- In-house GMP seminars and trainings for lasting change towards GMP compliance
- Auditing for qualification of suppliers, service providers and contract laboratories