- Project Management
- Assistance in Factory and Site Acceptance test for equipment and machinery
- Assistance in selecting equipment and machinery
- Assistance in defining and writing User Requirement Specification
GMP Design Reviews carried out by PharmaBioSolutions consultants, has proven extremely valuable to our clients. In each case the GMP review has identified a number of design deficiencies. By identifying the problem at the design stage, client has been able to save future rework and potential interruption to production.
Risk Assessment is an important part of the validation and a key requirement of USFDA and EMEA. It is also a requirement of the new Chinese GMP (Draft). PharmaBioSolutions Consultants Assistance in Risk Assessment including Impact Assessment, Critical Quality Attribute (CQA) and Critical Process Parameters (CPP) has been carried out with a number of clients in China.