The continuous application of regulations of national or international scope for the development of the products, is key so that your company can position itself as a reference of quality in its sector.
At Vality Pharma Consulting we offer the implementation, improvement or program of internal or external audits, to verify the correct assurance of the quality of your products, services, suppliers and facilities and certify that they operate in accordance with the standards to which they are accepted (FDA, NCF, ISO, GMP, GDP, GLP, etc.). for this we have a highly qualified staff.
We help you maintain your Quality Management system adapting to your normal work procedures, based on regulatory requirements, user requirements, manufacturing processes and management.
In order to develop a quality management system is essential, not only the knowledge of the organization, its infrastructure and operational processes. It is also fundamental to be familiar with the ISO 9001:2015 regulation, its function and adaptability in the organization applied. Vality Pharma Consulting develops assessments to verify the correct working process in the Quality Assurance System.
The pharmaceutical and biotechnology companies carry out comprehensive audits with the latest regulations and specifications of the GMPs.
Vality Pharma Consulting develops, implements and verifies the corrective action plans (CAP) in a complete, compatible and sustainable way adapting to the demands of our clients
At Vality Pharma Consulting we perform our work competently to ensure that our customers comply with FDA, GMP and other quality standards, such as the ICH Q10.
Desde Vality Pharma Consulting podemos realizar las siguientes auditorias:
Quality Risk Management (QRM) ICH Q8, ICH Q9, ICH Q10.
ISO-15378, ISO-22716, ISO-13485, GMP, GDP, GLP, 21 CFR parte 11 (ERES), GAMP V.
Manufactury Audits.
Internal Manufactury Audits [API, Pharma, QC, QA].
Previous Audits [MOCK-INSPECTIONS, FDA inspections, Clients, EDQM (CEP/COS)].