验证(英)学习资料.docVIP

DRAFT DRAFT PAGE 6 Validation …………………………Textbook Name PAGE 7 …………… …………… DRAFT Chapter x Chapter x Validation Objectives This chapter provides you with an overview of equipment, process and method validation and how they relate to the overall quality system. After completing this chapter, you will be able to: Understand how equipment, process, and method validation fits into the overall quality system. Describe pertinent regulations that apply to the field of validation and be familiar with the various types of government and third party validation documentation. Know and use common validation terminology. Distinguish procedures and outcomes for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). Discuss validation issues related to a specific piece of biomanufacturing equipment, given its function. Design a development study or validation protocol for a given piece of equipment. Properly follow a validation SOP. Accurately document the performance of a development and/or validation exercise. Initiate an investigation concerning a validation protocol deviation and assess its impact on product quality. Describe the change control process. Key terms Act: The Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.). Adulterated: Drugs manufactured without following proper GMPs. Analyst: The laboratory personnel performing the analytical method Analytical method: A laboratory procedure used to analyze a sample. BLA: Biologics License application, an application to the FDA for a license to market a biologic (biopharmaceutical). Aseptic Processing: A manufacturing process that relies on maintaining an aseptic environment in which the product is produced and packaged. Change Control: A formal process following a predetermined procedure set out in a Quality Assurance document or Master Validation Plan for making changes to equipment, systems, or procedures that may change the parameters or affe