!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 58: Phase-Appropriate GMP Requirements The United States Food and Drug Administration (FDA) published a final rule in the Federal Register on “Current…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 56: Artwork Development and Controls The development of labeling artwork is a collaborative process involving both the commercial side of the organization…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 57: Quality by Design Concepts To understand the most current thinking behind product development and regulatory expectations, it is important to understand…
!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…
!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…
