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
Electronic Work Instructions: A Use Case for No-Code Manufacturing App Technology
What are Electronic Work Instructions (EWI) Electronic Work Instruction’s (EWI) help eliminate paper procedures and forms on the shop floor
Retrospective Validation: PIC/S and legacy systems
For this edition of Call in for a Coffee we look at topic that is becoming increasingly important for Asia’s
MHRA ‘GXP’ Data Integrity Guidance
UK MHRA have just published the final version of the ‘GXP’ Data Integrity Guidance and Definitions Revision 1 on 09
Validating your ERP system, we explain why and how to do it
What is an ERP? ERP is short for Enterprise Resource Planning. Enterprise Resource Planning (ERP) is a term to define
PIC/S Adopts EU ANNEX 11
Originally the PHARMACEUTICAL INSPECTION CONVENTION / PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/s) adopted the EU GMP Guide Annex 11 on Computerised
GAMP5: Updated guidance on CSV
The Good Automated Manufacturing Practice (GAMP) guides have for the last 20 years provided a universally accepted approach for the
Validation of Spreadsheets
For this edition of Call in for a Coffee we look at another topic that is becoming increasingly important for
Regional players in the ASEAN pharmaceutical industry
Factorytalk publication in conjunction with CM Plus corporation (Japan) Regulatory and compliance challenges for local and regional manufactures in the
Overview of the pharmaceutical industry in the ASEAN region
Factorytalk publication in conjunction with CM Plus corporation (Japan) TOPIC 01 – OVERVIEW OF THE PHARMACEUTICAL INDUSTRY IN THE ASEAN
