GAMP stands for Good Automated Manufacturing Practice. So, more standard and complex compliance – GAMP 5 was released in 2008 which is an update of the earlier guideline versions discussed earlier. were developed so that these industries follow them before giving clearance to the vendors for commissioning the system.īut, in many cases, situations came where software defects, failed audits, led to a downfall in the quality of checking and computer software validation. Many standard guidelines like Annex 11, 21CFR Part 11 compliance, etc. Because, any deviation in operation or data recorded can cause vast scale bugs and errors in the final product which will affect the quality of the product.Īs manufacturing in these sectors started to boost up and more and more vendors started to give machines to these companies, a need was raised to make the systems foolproof and risk-free. Some industrial sectors like pharmaceuticals require strict adherence to guidelines for operating their computer systems.
In this post, we will study the GAMP 5 Compliance in pharmaceutical industries.
