!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 55: Filling and Packaging Records An essential aspect of a robust documentation program is the existence of records that provide a detailed…
Expiration Dating The guidelines for GMP require that the drug expiration date is noted on the label. Moreover, if the drug product is to be reconstituted at the time…
Each person engaged in parenteral product inspection operations must have the education, training, and experience, or any combination thereof, to perform his or her assigned function, whether that function…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 51: In-Process and Finished Goods Inspections The pharmaceutical industry has recognized the need for better and faster systems for inspection of in-process…
The expiration date of the reagent should be readily apparent on the container. For commercially procured reagents, the manufacturer-assigned expiration date is often used. If no expiration date is…
Staged Materials Staging materials properly is a key process that prevents contamination or substitutions in a filling process and is accomplished through good line-clearance procedures with appropriate checklists and…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 50: Environmental Monitoring Environmental monitoring is considered by regulators (United States Food and Drug Administration [FDA]) necessary to ensure that the material/products…
Warning Letter Citations Failure of pharmaceutical companies to adequately protect production lines from contamination and cross-contamination is a frequently cited Form 483 observation noted during establishment inspections. The focus…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 48: Reprocessed and Reworked Materials Reprocessing The reprocessing of any lot or batch of drug is given approval by quality control (QC)….
