SUPAC - Pharma Technology Transfer

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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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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
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