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- 05 Dec 2020, 16:51
#4348
Latest FDA Scale Up and Post Approval Changes Guidelines focused on, SUPAC - IR, SUPAC - MR and SUPAC - SS. In this section, we detailed the purpose of those guidelines and you can download the all the FDA SUPAC PDF guidelines for your reference.
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms
This guidance has been prepared by the Immediate Release (IR) Scale-up and Post Approval Change (SUPAC) Expert Working Group of the Chemistry Manufacturing Controls Coordinating Committee (CMC CC) of the Center for Drug Evaluation and Research at the Food and Drug Administration
Download Here
SUPAC-MR: Modified Release Solid Oral Dosage Forms
This guidance has been prepared by the Scale-up and Post approval Change Modified Release (SUPAC-MR) Working Group operating under the direction of the Chemistry Manufacturing Controls Coordinating Committee (CMC CC) and the Biopharmaceutics Coordinating Committee (BCC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA).
Download Here
SUPAC-SS: Nonsterile Semisolid Dosage Forms
This guidance has been prepared by the Scale-Up and Post Approval Change Semisolids (SUPAC-SS) Working Group operating under the direction of the Chemistry Manufacturing Controls Coordinating Committee (CMCCC) and the Biopharmaceutics Coordinating Committee (BCC) in the Center for Drug Evaluation and Research(CDER) at the Food and Drug Administration.
Download Here
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms
This guidance has been prepared by the Immediate Release (IR) Scale-up and Post Approval Change (SUPAC) Expert Working Group of the Chemistry Manufacturing Controls Coordinating Committee (CMC CC) of the Center for Drug Evaluation and Research at the Food and Drug Administration
Download Here
SUPAC-MR: Modified Release Solid Oral Dosage Forms
This guidance has been prepared by the Scale-up and Post approval Change Modified Release (SUPAC-MR) Working Group operating under the direction of the Chemistry Manufacturing Controls Coordinating Committee (CMC CC) and the Biopharmaceutics Coordinating Committee (BCC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA).
Download Here
SUPAC-SS: Nonsterile Semisolid Dosage Forms
This guidance has been prepared by the Scale-Up and Post Approval Change Semisolids (SUPAC-SS) Working Group operating under the direction of the Chemistry Manufacturing Controls Coordinating Committee (CMCCC) and the Biopharmaceutics Coordinating Committee (BCC) in the Center for Drug Evaluation and Research(CDER) at the Food and Drug Administration.
Download Here
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