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
BPOM release new draft of serialisation requirement in Indonesia
Back in December 2018, the National Agency of Drug and Food Control, Republic of Indonesia (abbreviated BPOM) issued Regulation 33
Pilot plants/clinical trials manufacturing left behind in the technology race to industry 4.0
I was previously (and proudly!) an engineer responsible for pilot plants for one of the top ten Pharma companies, such
Motivating Digital Change in Manufacturing: Stop Pushing Staff and Make Them Want to ‘Pull’
20 years ago, I was responsible for secondary packing and assembly of a complex anaesthetic product. We had a couple of automated
