Quality Assurance systems
Quality management is a key entry for Chempilots to facilitate R&D projects and custom productions for our medical device and pharmaceutical customers.
What we offer
We can establish a dedicated and appropriate quality assurance system that will contribute to customer’s future documentation needs. Any such quality assurance system will be designed to reflect the stage of R&D activity, and will be flexible, economical and time efficient in use.
QA requirements
Chempilots is running several R&D projects and custom medical productions simultaneously. Some of these activities are complying with custom quality procedures and/or formal quality system requirements.
We have know-how and experience in establishing and maintaining dedicated quality assurance systems formally complying with international guidelines or standards such as:
- OECD principles of Good laboratory practice (GLP) as specified by WHO’s guidelines
- ISO 13485 “Quality system - Medical devices – System Requirements for regulatory purposes”
- FDA Quality System Regulation (CGMP for Medical Devices & In Vitro Diagnostic Products), 21 CFR part 820
- EU guidelines to Good Manufacturing Practice (GMP) of Medical Products, Annex 18 similar to ICH Q7A (Active substances) starting materials
Our QA organisation
We have appointed dedicated teams to manage and execute projects and line operations, including a line quality responsible, where relevant. To stay efficient and ensure adequate overall performance in quality assurance and regulatory affairs, we have instituted a corporate quality system with basic quality procedures and attributes. Each project and line operation may take advantage of this, and any custom-specific requirements are added.
Contact us
For more information please contact Richard Schmidt on +45 44 39 61 15 or Paul Jansen on +45 44 39 61 14 (9-17 CET) or by e-mail.
