AUDITS AND INSPECTIONS
- Carrying out external audits within GMP and GDP
- Carrying out internal audits in production or distribution companies, or according to ISO standards (9001, 14001, 13485, 45001)
- Carrying out internal audits in production or distribution companies
- Carrying out external audits within SVP and SDP (within the Czech Republic and abroad, CMO, laboratories, service suppliers)
- Preparation for regulatory inspections (SUKL and other authorities)
- Professional consultation for defense during inspections/audits
- Audit/inspection coordination directly at your company
SETTING OF THE QMS SYSTEM
- Proposal and implementation of a quality control system for products manufactured within the framework of the HACCP, FAMI QS, ISO standards, or within their combination, including the GMP system
- Proposal and implementation of a quality management system (QMS) for distribution and manufacturing companies
- Proposal and implementation of a quality control system for products manufactured within the framework of the HACCP, FAMI QS, ISO standards, or within their combination
- Proposal, modification, mapping of individual processes within the QMS
- Management of deviations
- Management of changes
- Management of CAPA
- Selection and evaluation of suppliers
- Risk management and others, including processes of other departments
SERVICES OF A QUALIFIED PERSON
- Services of a qualified person for distribution, including registration for the distribution permit
- Services of a qualified person for production, including registration for the production permit
OTHER ACTIVITIES
- Person responsible for communication with MZČR regarding addictive substances and related services
- Ensuring training within the company (GDP, GMP, PHV, etc.)
- Qualification and validation of equipment, premises and electronic systems employed in the field of quality
