Pharmaceutical Good Manufacturing Practice Regulations Article 117

Manufacturers shall monitor and measure the characteristics of the product to verify that product requirements have been met.The foregoing shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements and documented procedures.Manufacturers shall maintain the evidence of conformity with the acceptance criteria. Records shall indicate the person(s) authorizing release of product.Product release and service delivery shall not proceed until the planned arrangements have been satisfactorily completed.