!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 32: Maintenance and Metrology Systems All instruments that control manufacturing facilities, utilities, and equipment must be maintained to ensure they are functioning…
Cleaning validation may be conducted during the PQ phase or the tradi-tional process validation phase in parallel with the manufacturing of the validation batches. The details of the philosophy…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 27: Facilities Introduction Good manufacturing practices (GMP) were invoked to maintain the quality of pharmaceutical and biopharmaceutical products manufactured for human consumption….
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 26: Reserve Samples and Retains 21 CFR 211.170 requires an appropriately identified reserve sample that is representative of each lot in each…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 21: Instrument Control and Record Keeping All laboratory instrumentation must be maintained to ensure proper functioning. Instrumentation is numbered so it can…
Pharmaceutical good manufacturing practices (GMP) vary in the level of detail used to describe the ways that pharmaceutical manufacturers should ensure that their suppliers contribute to the quality of…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 17: Product Trend Requirements Organizations, no matter what industry they’re in, generate a significant amount of data as a result of running…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 16: Product Quality Complaints versus Adverse Event Reports The United States Food and Drug Administration (FDA) places a significant amount of emphasis…
