Revision of EU Annex 11 – The need & expectations for update
EU Annex 11 is the section of the European Medicines Agency (EMA)’s Good Manufacturing Practice (GMP/GxP) for “all forms of
GAMP 5 2nd Edition: What You Need to Know
Background ISPE’s GAMP is the leading organisation globally providing guidance to use software in the GxP regulated industries. Its guidance
(Factorytalk in the press) Driving Digitization of Thailand’s Life Sciences and Healthcare Sectors Towards Thailand 4.0 with Factorytalk Software and Digital Solutions
(Factorytalk in the press) Driving Digitization of Thailand’s Life Sciences and Healthcare Sectors Towards Thailand 4.0 with Factorytalk Software and
CAPA : A Concise Guide to Continuous Improvement in Business
The CAPA system is widely recognized as an effective tool for identifying and systematically addressing problems. This post will briefly overview the
Annex 11 : Electronic signature and Batch release for Medicinal products
The Annex 11 regulation provides guidance on how to implement an electronic signature system that meets the requirements of the
21 CFR part 11 : Electronic records and Electronic signatures
The Code of Federal Regulations (CFR) is the official codification of the general and permanent rules published in the Federal
The Key Differences Between CFR Part 11 and Annex 11
The compliance landscape for electronic records and signatures is constantly evolving. Two key sets of regulations that have shaped this landscape are
Online Sale of Medicines In Indonesia
The Indonesian National Drug and Food Control Agency or locally known as BPOM released a regulation No 8 Year 2020
Good Distribution Practices Update in Indonesia
In March 2020, BPOM released a revised version of Good Distribution Practices (GDP) No 6/2020, replacing the same regulation (No
Overcoming the EBR challenge for smaller pharma manufacturing sites
How can smaller pharma sites get world class EBR? Here’s a common situation: Smaller pharma manufacturing sites and Tier 2 and 3 sites in large pharma enterprises often
