The current dynamics of the pharmaceutical market involves outsourcing most of the activities that traditionally are performed by internal staff, in the areas of Quality Assurance, R & D, IT, etc.
TDV offers specialized technicians with extensive experience in several activities related to compliance with GMP, as ongoing support for specific projects or as reinforcement of internal resources in different areas related to GMP compliance, for example:
- Documentation review.
- SOP’s preparation.
- Review of Batch Records and Quality Control documentation.
- Annual Product Review/Product Quality Review report preparation.
- Audits of validation documents (protocols, tests and reports).
- Audits of Quality Control documentation.
- Assistance in qualification of:
- Process Equipment
- Control systems
- Computerised systems
The periods of time and intensity for providing the service is adjusted according to the customer requirements with total flexibility. It can be a full time work or part time, number of hours or days per week/month.
For further information about Outsourcing, please contact: