Quality Assurance systems

Quality management is a key competence for Chempilots to facilitate R&D projects and custom productions for our medical device and pharmaceutical customers.

Chempilots offers a quality system based on ISO 9001 for productions. We can also establish custom quality assurance systems designed to reflect the stage of R&D activity or customize existing quality assurance systems to comply 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 Q7 (Active substances) starting materials.

QA organization
Dedicated teams are appointed 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 4495 1661 (9-17 CET) or by e-mail.