Category: ISPE

ISPE

GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control

GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2011

ISPE GAMP Guide: Records and Data Integrity

ISPE GAMP Guide: Records and Data Integrity

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2017

ISPE GAMP Good Practice Guide: Computerized GCP Systems & Data

ISPE GAMP Good Practice Guide: Computerized GCP Systems & Data

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2017

ISPE Good Practice Guide: Process Gases

ISPE Good Practice Guide: Process Gases

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2011

ISPE Good Practice Guide: Single-Use Technology

ISPE Good Practice Guide: Single-Use Technology

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2018

ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities

ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2017

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2012

ISPE Good Practice Guide: Comparator Management

ISPE Good Practice Guide: Comparator Management

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2012

GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)

GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2012

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

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

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