3.2.S.2.5 Process Validation and/or EvaluationThe manufacturing process is capable of consistently meeting product specifications. This is based on knowledge of process parameters, product attributes and their inter-relationship, according to the equirements of the IPEC PQG GMP guide and/or EXCiPACT® Certification Standard. Aftersignificant changes, the impact on process capability is assessed and documented.The requirements outlined in the current IPEC Federation 'Validation Guide' are fulfilled by our processes for the product.