Category: Resource Type

EMA/CAT/80183/2014: Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene Therapy Medicinal Products (GTMP)
The EMA guideline on quality, non-clinical and clinical aspects of gene therapy medicinal products (GTMP´s) builds on earlier documentation and [...]
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PIC/S Guidelines on GDP of Active Substances for Medicinal Use
This document provides Pharmaceutical Inspection Convention Cooperation Scheme (PIC/S) Guidelines on the Principles of Good Distribution Practice of Active Substances [...]
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Data Integrity Library
This library is a collection of up to date publications associated with the topic of data governance and data integrity.  [...]
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Supplier Assessment Questionnaire Kit
Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual [...]
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ICH Q12 on Pharmaceutical Product Lifecycle Management was issued for public consultation
ICH Q12 Draft Guideline provides the framework to facilitate the management of post-approval CMC changes in a predictable and efficient [...]
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Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry
On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. This draft guidance aims [...]
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