Cleanrooms
When it is necessary to control the environment, specifications for parameters such as temperature, humidity, colony-forming units (CFUs), and particulates per cubic foot should be…
Specifications
Inactive Ingredients (Excipients) Excipients are defined as ingredients added to the drug formulation for purposes other than the therapeutic or medicinally active effect. They are largely inert substances that…
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…
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…
