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/GLP 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, GLP, GCP inspection, also in third countries,
- Support in GMP implementation, including GMP 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.