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Category: ISPE

ISPE

ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems

Posted on September 11, 2020December 21, 2019 by admin

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 02/01/2008

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

Posted on September 11, 2020December 21, 2019 by admin

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

ISPE Sustainability Handbook

Posted on September 11, 2020December 21, 2019 by admin

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 12/01/2015

ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities

Posted on September 11, 2020December 21, 2019 by admin

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

ISPE Good Practice Guide: Maintenance

Posted on September 11, 2020December 21, 2019 by admin

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2009

ISPE Good Practice Guide: Operations Management

Posted on September 11, 2020December 21, 2019 by admin

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

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

Posted on September 11, 2020December 21, 2019 by admin

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

ISPE Baseline Guide: Volume 2 – Oral Solid Dosage Forms

Posted on September 11, 2020December 21, 2019 by admin

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

Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals

Posted on September 11, 2020December 21, 2019 by admin

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2006

ISPE Good Practice Guide: Technology Transfer

Posted on September 11, 2020December 21, 2019 by admin

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 05/01/2014

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SAE INTERNATIONAL

SAE standards are internationally recognized for their role in helping ensure the safety, quality, and effectiveness of products and services across the mobility engineering industry. They contain detailed production and interoperability guidelines; clarify legal and regulatory grey areas; condense product development cycles; ensure consistency and high quality in manufacturing; and lead the way to maximum performance.

IEEE

IEEE is the world’s largest technical professional society, serving members in computing, electrical engineering and electronics. Comprised of 37 societies and councils, IEEE publishes technical journals, magazines, proceedings, and more than 800 standards.

JIS

JIS covers industrial and mineral products, comparable to standards established by various industrial associations for specific needs, or standards established and used by companies (operation manuals, products specifications etc.). The need for common practices in companies of the same industrial sector leads to the establishment of industrial association standards, and the same need in terms of wider applications promotes the establishment of JIS.

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