Parenteral Product Inspection
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…
In-Process and Finished Goods Inspections
!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…
Laboratory Handling Controls
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…
Filling Operations and Controls
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…
Environmental Monitoring
!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…
Reprocessed and Reworked Materials
!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)….
Contamination and Cross-Contamination
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…
Dispensing and Weighing Controls
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 45: Dispensing and Weighing Controls Dispensing and weighing controls should be such that the identity, purity, and quality of the raw materials…
Stability Programs
Commercial Support Stability As part of the submission process, a company will include a commitment to continue stability evaluation over the commercial life of the product. The stability commitment…
Laboratory Record-Keeping and Data Requirements
Preparation of solutions to be used in the analysis can be documented on the controlled document or in a logbook designated for such preparations. Most laboratories have a solution…
