Manufacturing Description definition

Manufacturing Description or "MAN" means the Master Production instructions according to the EU GMP Guidelines Part II, Section 6, Subsection 6.4 for the USP, DSP or the Drug Product manufacturing process.

Examples of Manufacturing Description in a sentence

  • Subject always to the provisions of the Quality Agreement, ▇▇▇▇▇▇▇▇▇▇ will not make any modification to the Manufacturing Description (as validated), any other Specification, raw materials, components, or testing without the written consent of Dyax.

  • SCHERING will document the conduct of all the procedural steps stipulated in the Manufacturing Description as well as all in-process controls in Batch-specific records as customarily kept by SCHERING.

Related to Manufacturing Description

  • Project Description means the document that describes the Project's Reduction activities and that uses either the VCS Project Description Template or the project description template specified by the relevant Approved GHG Program;

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Product Description means the description of each Hospitality Package, or series of Hospitality Packages which are the subject of any Confirmation of Purchase.

  • Manufacturing Process means any process for—

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.