Site Master File (SMF) and Drug Master File (DMF)
Content of Site Master Files Chapter 1. General Information • Name, address, and company description (C.1.1): Includes a brief description of the company, relation to other sites, and…
PHARMACY
Traceability and Sourcing
GMP regulations place responsibility for ensuring the quality of the materials used to manufacture drug products squarely on the shoulders of the pharmaceutical company. The globalization of the pharmaceutical…
Documents and Records Management
At the highest level of the documentation hierarchy in most companies sits the quality manual, which defines the corporate objectives related to quality and compliance. It establishes a figurative…
Automated or Computerized Systems
• Identifying the need. Will an automated or computerized system provide the best solution to the business problem? • Proposing solutions. Solutions can be technical (that is, the computer…
Scale-up and Transfer Activities
Hold-Time Studies As the name implies, a study must exist for every time lapse (that is, hold time) anticipated or intended to occur between any two API and drug…
Raw Materials, Packaging, and Infrastructure for Product Development
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 59: Raw Materials, Packaging, and Infrastructure for Product Development The United States Food and Drug Administration (FDA) provides guidance for raw materials,…
New Product Development Studies and Reports
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 60: New Product Development Studies and Reports Drug development is the process of taking a new chemical lead through the stages necessary…
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…
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…
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…
