Quality Management System
- Implementation of Quality Management System;
- Implementation of Good Manufacturing Practices (GMPs);
- Implementation of Good Laboratory Practices (GLPs);
- Implementation of Good Documentation Practices (GDPs);
- Preparation and review of Standard operating procedures (SOP);
- Implementation of a system for Suppliers’ Qualification (pharmaceutical ingredients and service providers);
- Quality audits, aiming for ANVISA and MAPA compliance;
- Management and treatment of deviations;
- Management and treatment of Change Control;
- Implementation of investigation of OOS test results (Out-of-Specification);
- Cleaning Validation;
- Validation of production processes.
International GMP Certification
- Implementation of quality improvements geared to international audit of ANVISA / MAPA;
- Preliminary assessment of the manufacturing plant regarding compliance with GMP, focusing on audits by regulatory agencies
- Evaluation and monitoring of action plans;
- Follow-up of inspections of GMP certifications.
Validation
- Support and/or development of Validation Master Plan;
- Support and/or development of protocols and reports for validation of analytical methods, cleaning and process;
- Support and/or execution of validations of analytical methodology, cleaning and process;
- Analytical method transference.
Training and Professional Qualification
- Liquid and Gas Chromatography;
- Support on the understanding of monographs, ANVISA and MAPA Guides and compendiums related;
- Validation of Analytical Methods;
- Cleaning Validation;
- Analytical methods transference;
- Customized lectures and trainings.