Manufacturers must control their operations through product and process qualification and validation, as required by the GMP.
At Azierta, through the support of implants, we can carry out validations in order to comply with the quality standards of each company and guarantee the quality of the medicines.
Azierta Validations Support – Support Through Implants
Our experts are constantly updated on Quality Management, Good Manufacturing Standards and Risk Management.
- Risk analysis management, if applicable.
- Preparation of the validation protocol.
- Compilation of results.
- Preparation of the validation report.
- Optimization of equipment and room cleaning.
- Confirm the effectiveness of any cleaning procedure.
- Global support in cleaning validations, from the study, rationalization, documentation to the implementation of new periods between the cleaning of equipment and rooms.
- Evaluation of cleaning validations performed and status
- Critical evaluation of rooms and equipment
- Work plan proposal
- Documentation (change controls, protocols, risk analysis, SOP changes...)
- Execution of the defined sampling plan
- Preparation of the final report and closure of change control
Advice and implementation of quality systems