2014年9月30日 · The document discusses SUPAC (Scale-Up and Post-Approval Changes) guidances issued by the FDA for pharmaceutical manufacturing process changes. It provides …

2013年1月19日 · The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It …

2023年4月7日 · This guidance gets together and replaces the below-mentioned scale-up and post-approval changes guide for the pharmaceutical industry: • SUPAC-IR/MR: Immediate …

2019年12月19日 · The acronym "SUPAC" stands for "Scale-Up and Post-Approval Changes". • It refers to the FDA-recommended testing and filing actions to be taken by a pharmaceutical firm …

This document provides guidance on post-approval changes (SUPAC) for drug applications. It discusses SUPAC documents, levels of changes, and recommendations for changes in …

2020年5月14日 · PDF | basic details about supac guidelines | Find, read and cite all the research you need on ResearchGate

2011年7月24日 · The scale-up process and the changes made after approval in the composition, manufacturing process, manufacturing equipment, and change of site have become known as …

The document discusses scale up and post approval changes (SUPAC) for pharmaceutical products. It addresses what SUPAC is, types of SUPAC, and levels of changes for …

2021年1月23日 · SUPAC guidelines provide guidance for scale up and post-approval changes made to a drug's composition. The purpose of the guidelines is to ensure any manufacturing …

SUPAC.ppt - Free download as PDF File (.pdf), Text File (.txt) or view presentation slides online. SUPAC documents provide guidance for post-approval changes to drug products. They …