Scale up and Post Approval Chenges (SUPAC).pdf

Scale up and Post Approval Chenges (SUPAC).pdf

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  See discussions, stats,and author profiles for this publication at: https://www.researchgate.net/publication/369560284 Scale -Up and Post Approval Changes [SUPAC] Mr. Sagar Kishor Savale [Technology Transfer Scientist] Presentation · March 2023 CITATIONS 0 1 author: Some of the authors of this publication are also working on these related projects: Analytical and Bioanalytical Method Development and Validation of Curcumin and Gefitinib by using UV spectroscopy and RP-HPLC Technique View project Arc Reactor View project Sagar Kishor Savale [email protected] 85 PUBLICATIONS 140 CITATIONS SEE PROFILE All content following this page was uploaded by Sagar Kishor Savale on 28 March 2023. The user has requested enhancement of the downloaded file.
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  Scale - Upand Post Approval Changes [SUPAC] Mr. Sagar Kishor Savale [Technology Transfer Scientist]
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  Technology transfer ofa pharmaceutical product from research to the production floor with simultaneous increase in production outputs is commonly known as scale - up. In simple terms, the process of increasing batch size is termed as scale- up. Conversely, scale- down refers to decrease in batch size in response to reduced market requirements Scale - Up and Post Approval Changes
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  (1) The componentsor composition, (2) The site of manufacture, (3) The scale-up of manufacture, and (4) The manufacturing (process and equipment)
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  SUPAC - IR LEVELCLASSIFICATION EXCIPIENT RANGES (%w/w of total formulation) I Changes in excipients, expressed as % (w/w) of total formulation, less than or equal to excipient % ranges Filler ±5 Disintegrant ±3 Binder ±0.5 Lubricant ±0.25 Glidant ±1 II Change in technical grade of excipients Filler ±10 Disintegrant ±6 Binder ±1 Lubricant ±0.5 Glidant ±2 III Higher than SUPAC IR Level 1 and Level 2 excipient ranges.
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  SUPAC - MRNon-Release Controlling Excipients LEVEL EXCIPIENT RANGES (%w/w of total formulation) I Upto SUPAC - IR Level 1 excipient ranges II Upto SUPAC - IR Level 2 excipient ranges III Higher than SUPAC IR Level 1 and Level 2 excipient ranges.
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  SUPAC - MRRelease Controlling Excipients LEVEL CLASSIFICATION I ≤ 5% w/w change based on total release controlling excipient II ≤ 10% w/w change based on total release controlling excipient III > 10% w/w change based on total release controlling excipient content
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  SUPAC – SSComponents and Composition Preservative LEVEL CLASSIFICATION I Quantitatively 10% or less change in the approved amount of preservative II 10% to 20 % change in the approved amount of preservative III > 20% change in the approved amount of preservative
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  SUPAC - SSNon Sterile Semisolid Dosage LEVEL CLASSIFICATION I Change in supplier or technical grade of any other excipient Upto 5 % change in approved amount of ingredient II Upto >5 % and ≤ 10 % change in approved amount of ingredient III change in approved amount of ingredient. Change in crystalline form of the drug substance, if the drug is in suspension
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  Manufacturing Site Changes LEVELCLASSIFICATION I Site change within a single facility II Same continuous campus & Common personnel III Different campus & Different personnel
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  Batch Size Change(Scale Up) LEVEL CLASSIFICATION I Change in batch size, up to and including a factor of 10 times the size of the pilot/biobatch II Changes in batch size beyond a factor of ten times the size of the pilot/biobatch
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  Equipments Chenges LEVEL CLASSIFICATION IAlternate equipment of same design and principles II Change to equipment of different design and principle
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  Manufacturing Process Chenges LEVELCLASSIFICATION I Chenge in equipment operating condition within approved specification limit II Chenge in equipment operating condition beyond specification limit III Changes in the type of process used (e.g. wet granulation to direct compression
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  Mr. Sagar KishorSavale [Technology Transfer Scientist] [email protected] View publication stats