MAIN AREAS OF ACTIVITY
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In TH consultants, we design solutions that allow adding value to healthcare products' development and manufacturing processes, providing competitiveness and compliance with National and International Quality Standards.
1. GxP implementation
3. Quality Assurance and Quality Management System Implementation
6. Validations and Qualifications
7. Quality Control
8. Regulatory Affairs
9. Risk Management
Assessment and evaluation the level of compliance with Good Manufacturing Practices, Good Laboratory, Storage and Distribution Practices Identification of improvement opportunities, and design and follow up implementation plans to achieve GXP.
Recommendation of strategic partnerships with equipment and services' suppliers and with research and innovation institutions. Support in the development of productive processes and/or innovative methodologies and technologies.
Quality Assurance and Quality Management System Implementation – QMS. Development and Implementation of Quality Tools: CAPA plans, Nonconformities management, OOS, Root Cause Analysis, Risk Assessment, Quality Indicators, Change Control, etc. Build, review and implementation of Standard Operation Procedures (SOP), and other register sheets. Product Annual Review (PAR). Filing system. Information management.
Internal and External Audits. Current or under study Suppliers or Third Parties with range about: Quality Management Systems, Productive and Supportive Installations and Processes, Quality Control, Quality Assurance and Technical Areas. Annual Audit Plan.
Implementation and review of Process Controls, determination of Critical Control Points. Development and Implementation of Key Performance Indicators (KPI).
Validations and Qualifications
Design, development, and Implementation of Validation Master Plan, Protocols and Reports of: Validation of Manufacturing Processes, including Biological processes, Cleaning Validation, Aseptic Packaging and Rating of Clean Areas, Equipment and Critical Services, Cold Chain. Computer Systems Validation (CSV). Building procedures, Protocols and Validation Reports of analytic, biological and microbiological Methodologies.
Analysis techniques, adequacy of methodologies and validation of compendial procedures according to National and International Pharmacopoeia. Development of procedures and process Technology Transfer Stability. GLP.
Review and update Registration dossiers of pharmaceutical, veterinarian, cosmetic Products and medical devices, at local and regional level and in highly regulated countries. Common Technical Document (CTD).
Design, development and implementation of the Risk Management program. Elaboration of related documentation. Specific trainings for the use of risk assessments tools.
Development of technical training plans designed for each client. Connection with other training institutions.