Overview of the GxPs for the Regulatory Professional

Introduction to the GxPs ... 236 Introduction to the GLPs ... 237History of the GLPs ... 238 GLPs Today? ... 239US GLP Regulations ... 239 GLP Guidance Documents ... 239Organization and Personnel ... 242 Facilities and Equipment ... 244 Testing Facility Operations... 244 Test and Control Article ... 244 Protocols, Records, and Reports... 245Compliance with GLPs ... 246 Introduction to Current GMPs ... 248History of the cGMPs... 248 cGMPs Today ... 250 GMP Regulations and Guidance ... 252 Compliance with cGMPs ... 254GMP Inspections and Consequences ... 255 cGMP References... 256Introduction to the GCPs ... 256 History of the GCPs ... 257 GCPs Today ... 258US GCP Regulations ... 258 GCP Guidance Documents ... 262 Who Is a Sponsor and How Do They Meet Their Obligations?... 263 IRB Responsibilities... 263 Investigator Responsibilities ... 264Good . . . practices (GxPs) is an acronym commonly used in many regulated industries such as the drug, device, or biologic industry to describe a collection of quality guidelines that are based on regulations, guidance, and industry standards to ensure that a product or process will produce results that are consistently fit for the intended purpose. In the pharmaceutical industry, GxP is employed in several aspects of drug development and commercialization, including nonclinical research, manufacturing, and clinical research. The big three GxPs, for which we will attempt to provide a high-level and practical overview in this chapter, include good laboratory practices (GLPs), good manufacturing practices (GMPs), and good clinical practices (GCPs).