Common use of Validation and Testing Clause in Contracts

Validation and Testing. All new equipment must be validated and tested. The result of this validation and testing will form the basis for the Customer’s approval of the delivery (accepted costumer acceptance test), upon which the production may be initiated. An overview of the validation and testing process and responsibilities is provided in table 5.1. Sykehusapotekene HF (SAHF) will, in collaboration with the Contractor, validate and test the solution in accordance with the following standards: o EU Guidelines to good manufacturing practice for medicinal products for human and veterinary use vol 4; annex 1 Manufacture of sterile medicinal products o PIC/s Guide to good practices for the preparation of medicinal products in Healthcare establishments o Good Automated Manufacturing Practice – (GAMP) – GAMP 5 – A risk-based approach to compliant GxP computerised systems o EU Guidelines to good manufacturing practice for medicinal products for human and veterinary use vol 4; chapter 4: Documentation