Category: ISPE

ISPE

Posted in ISPE

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 4 – Process Performance and Product Quality Monitoring System

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

Posted in ISPE

ISPE Good Practice Guide: Process Gases

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

Posted in ISPE

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

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

Posted in ISPE

ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry

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

Posted in ISPE

ISPE Baseline Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 07/01/2017

Posted in ISPE

ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2017

Posted in ISPE

ISPE Good Practice Guide: Technology Transfer

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

Posted in ISPE

ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2012

Posted in ISPE

ISPE Good Practice Guide: Management Engineering Standards

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 08/01/2016

Posted in ISPE

ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2017

Posted in ISPE

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 1 – Product Realization using QbD, Concepts and Principles

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

Posted in ISPE

ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2013