Category: ISPE

ISPE

ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring

ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring

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

ISPE Baseline Guide: Volume 3 – Sterile Product Manufacturing Facilities, Third Edition

ISPE Baseline Guide: Volume 3 – Sterile Product Manufacturing Facilities, Third Edition

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 04/01/2018

ISPE Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities

ISPE Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities

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

ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry

ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011

ISPE Good Practice Guide: Technology Transfer

ISPE Good Practice Guide: Technology Transfer

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

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 – Product Realization using QbD, Illustrative Example

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 – Product Realization using QbD, Illustrative Example

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011

GAMP Good Practice Guide: Data Integrity – Manufacturing Records

GAMP Good Practice Guide: Data Integrity – Manufacturing Records

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2019

GAMP Good Practice Guide: Electronic Data Archiving

GAMP Good Practice Guide: Electronic Data Archiving

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2007

ISPE Good Practice Guide: Interactive Response Technology

ISPE Good Practice Guide: Interactive Response Technology

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011

ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion Volume to GAMP 5

ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion Volume to GAMP 5

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