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
The CAPA system is widely recognized as an effective tool for identifying and systematically addressing problems. This post will briefly overview the
The Annex 11 regulation provides guidance on how to implement an electronic signature system that meets the requirements of the
The Code of Federal Regulations (CFR) is the official codification of the general and permanent rules published in the Federal
The compliance landscape for electronic records and signatures is constantly evolving. Two key sets of regulations that have shaped this landscape are
The Indonesian National Drug and Food Control Agency or locally known as BPOM released a regulation No 8 Year 2020
In March 2020, BPOM released a revised version of Good Distribution Practices (GDP) No 6/2020, replacing the same regulation (No
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
Back in December 2018, the National Agency of Drug and Food Control, Republic of Indonesia (abbreviated BPOM) issued Regulation 33
I was previously (and proudly!) an engineer responsible for pilot plants for one of the top ten Pharma companies, such
20 years ago, I was responsible for secondary packing and assembly of a complex anaesthetic product. We had a couple of automated