Category: ISPE

ISPE

Posted in ISPE

ISPE Good Practice Guide: Asset Management

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2019

Posted in ISPE

GAMP Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2010

Posted in ISPE

ISPE Guide: Biopharmaceutical Process Development and Manufacturing

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/31/2013

Posted in ISPE

ISPE Good Practice Guide: Operations Management

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2016

Posted in ISPE

ISPE Baseline Guide: Volume 5 – Commissioning and Qualification, 2nd Edition

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2019

Posted in ISPE

GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2005

Posted in ISPE

ISPE GAMP RDI Good Practice Guide: Data Integrity – Key Concepts

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/01/2018

Posted in ISPE

ISPE Baseline Guide: Volume 2 – Oral Solid Dosage Forms

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2016