Open AccessCompliance issues for the contract manufacturing of cgmp gene therapy products
Author(s) -
Webster Heide Seitz
Publication year - 1997
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/(sici)1099-1786(199709)2:3<135::aid-qaj48>3.0.co;2-f
Subject(s) - compliance (psychology) , business , psychology , social psychology
The contract manufacturing of biologics under current Good Manufacturing Practice (cGMP) regulations presents many unique compliance issues. The goal of any cGMP manufacturing organisation is to provide high quality products in a cost effective and timely manner using controlled and well‐documented procedures. For contract manufacturers, the accomplishment of this goal is particularly challenging due to the multiple products that are made and the variety of processes required for their production. A contract manufacturer must design a facility and operations plan capable of managing the variety of projects they may be asked to perform. The firm must also develop detailed policies and procedures regarding all of its operations to ensure compliance with all cGMP and safety regulations, as well as client expectations. © 1997 John Wiley & Sons, Ltd.