In the last decade, computerised systems have become a vital part in the manufacture of Active Pharmaceutical Ingredients. Typical applications are Process Control Systems (DCS, PLC,…
Category: QualityManagement
Attention: This validation plan is applicable to software or computerized systems only. It is not applicable to physical equipment It defines the phases of validation…
S1=Seiri=Sort=Clear up “Separate things which you need from things you don’t need” Table 1. Check results for step S1 # Yes No Check list for…
Citation: Martin, J. R. Not dated. What is the red bead experiment? Management And Accounting Web. https://maaw.info /DemingsRedbeads.htm The components of the red bead experiment include…
Copyright by Rob Nix My first experience with the word “culture” comes from my high school science class. We were to grow a living organism…
DIMENSIONAL LAYOUT ERRORS By James R. Howe When measuring the distance between two bores of equal size a pin to pin method is usually…
Here you have some animated GIF, propriety of Copyright of THE RED ROAD.
A cleanroom is a controlled environment where products are manufactured. It is a room in which the concentration of airborne particles is controlled to specified limits.…
Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. Minimizing equipment downtime has the potential to impact the efficiency and economics of…
The primary intent of the IPEC Risk Assessment Guide for Pharmaceutical Excipients (RAG) is to provide a systematic and scientifically sound methodology for the evaluation of…