Examples of Major Changes – Likely to impact on product stability (2)
{"Image DocumentName": "Examples of Major Changes \u2013 Likely to impact on product stability (2)", "Image ImageDescription": "Change of storage conditions. Change in specifications of the drug product or API. Change in test procedures linked with a change in specification. Change in dimensions of a sustained release formulation. Major changes in manufacture of the drug product. Change from wet granulation to direct compression of dry powder. Site change to a contiguous facility on the same campus or change of the manufacturing site to a different campus. Change in batch size beyond 10 times the size of the original batch. Change to equipment of different design and different operating principles.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}