Auditing

AUDITING OF MANUFACTURING FACILITIES AND ASSESSMENT OF THE DOCUMENTATION

We believe that in a well-planned project there is no place for random elements as each component is important. Having trustworthy partners for cooperation is essential, thus we have come a long way in obtaining reliable subcontractors and business partners which enabled us to develop appropriate mechanisms in terms of their assessment.
We offer services in the field of API/contract manufacturers as well as analytical and bioanalytical laboratories assessment. We can verify all the necessary documentation and audit manufacturing facilities/laboratories to make sure they work in accordance with GMP/GL requirements and that their analytical and technological capabilities fit to a given project.

---

Exemplary services offered:

Finding of potential business partners including API and drug product contract manufacturers, analytical and bioanalytical laboratories, CROs for nonclinical and clinical trials
Auditing activities related to API (DMF/ASMF assessment, full support in case of ASMF preparation and/or CEP procedure, if needed)
Assessment of API manufacturing facilities (including biological and biotechnological) and support with GMP and/or other quality troubleshooting,
Audits of contract manufacturers (non-sterile and sterile forms).
Audits of analytical and bioanalytical laboratories for GMP/GLP compliance and their applicability for use in specific projects,
Support during GMP, GL, GCP inspection, also in third countries, Support in GMP implementation, including MP for ATMPs,
Preparation and negotiation of quality and supply agreements with subcontractors (including contract manufacturers and CROs),
Import and transport organization and management of medicinal products in accordance with
GDP, including audits of transport companies / warehouses and transport validation.