Scale up and Post Approval Chenges (SUPAC).pdf
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This document discusses scale-up and post approval changes (SUPAC) for pharmaceutical products. It defines scale-up as increasing batch size from research to production. SUPAC includes changes to components, manufacturing site, scale of manufacture, and manufacturing process/equipment. It provides classifications (Levels I-III) for types of changes to excipients, batch size, equipment, and processes. Level I changes typically require less supporting validation/documentation than Level II or III changes. The presentation provides guidance on classifying different post-approval changes to determine regulatory submission requirements.
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Scale -Up and Post Approval Changes [SUPAC] Mr. Sagar Kishor Savale
[Technology Transfer Scientist]
Presentation · March 2023
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Sagar Kishor Savale
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Scale up and Post Approval Chenges (SUPAC).pdf
- 1. 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 sagar.savale@glenmarkpharma.com 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.
- 2. Scale - Up and Post Approval Changes [SUPAC] Mr. Sagar Kishor Savale [Technology Transfer Scientist]
- 3. Technology transfer of a 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
- 5. (1) The components or composition, (2) The site of manufacture, (3) The scale-up of manufacture, and (4) The manufacturing (process and equipment)
- 6. SUPAC - IR LEVEL CLASSIFICATION 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.
- 7. SUPAC - MR Non-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.
- 8. SUPAC - MR Release 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
- 9. SUPAC – SS Components 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
- 10. SUPAC - SS Non 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
- 11. Manufacturing Site Changes LEVEL CLASSIFICATION I Site change within a single facility II Same continuous campus & Common personnel III Different campus & Different personnel
- 12. 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
- 13. Equipments Chenges LEVEL CLASSIFICATION I Alternate equipment of same design and principles II Change to equipment of different design and principle
- 14. Manufacturing Process Chenges LEVEL CLASSIFICATION 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
- 15. Mr. Sagar Kishor Savale [Technology Transfer Scientist] sks747202@gmail.com View publication stats