Qualification and Validation
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…
Maintenance and Metrology Systems
!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…
Facilities
!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….
Reserve Samples and Retains
!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…
Instrument Control and Record Keeping
!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…
Supplier and Contractor Quality Management
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…
Product Trend Requirements
!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…
Product Quality Complaints versus Adverse Event Reports
!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…
