Phase-Appropriate GMP Requirements

Aug 21, 2016 by in PHARMACY Comments Off on Phase-Appropriate GMP Requirements

!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…

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Artwork Development and Controls

Aug 21, 2016 by in PHARMACY Comments Off on Artwork Development and Controls

!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…

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Quality by Design Concepts

Aug 21, 2016 by in PHARMACY Comments Off on Quality by Design Concepts

!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…

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Filling and Packaging Records

Aug 21, 2016 by in PHARMACY Comments Off on Filling and Packaging Records

!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…

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Labeling Operations and Controls

Aug 21, 2016 by in PHARMACY Comments Off on Labeling Operations and Controls

  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…

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Parenteral Product Inspection

Aug 21, 2016 by in PHARMACY Comments Off on 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…

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In-Process and Finished Goods Inspections

Aug 21, 2016 by in PHARMACY Comments Off on 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…

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Laboratory Handling Controls

Aug 21, 2016 by in PHARMACY Comments Off on 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…

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Environmental Monitoring

Aug 21, 2016 by in PHARMACY Comments Off on 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…

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