Details

Autor(en) / Beteiligte

• Chatterjee, Bikash

Titel

Pursuing Pharmaceutical Quality and Economy

Ist Teil von

• Biopharm International, 2006-06, Vol.19 (6), p.58

Ort / Verlag

Monmouth Junction: MultiMedia Healthcare Inc

Erscheinungsjahr

2006

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• The pharmaceutical industry's recent emphasis on continuous improvement, operational excellence, and process analytical technology has motivated us to evaluate the basic tenets of our approach to quality. Historically, the ability to ensure that a drug meets its intended form, fit, and function has been achieved through the application of the quality infrastructure, i.e., standard operating procedures, policies, specifications; qualification or validation, i.e., commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), process validation; and testing, i.e., in-process and final release.