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1. Granularity of TT Process
(API, excipients, finished products, packaging materials)
Mr. Shubham Sharma
M. Pharma (Pharmaceutics)
SOP, Mangalayatan University, Aligarh

2. Definition: In the Technology Transfer process (like transferring manufacturing knowledge
from R&D to production), granularity means the level of detail in which the information is
shared or documented.
• High granularity → very detailed, step-by-step information.
• Low granularity → broad, summarized information.
Why is it Important: Granularity ensures that when a process (like making a drug product)
is moved from one team/site to another, nothing is lost or misunderstood. The right level
of granularity prevents errors, saves time, and ensures consistent product quality.
Examples: API (Active Pharmaceutical Ingredient):
1. Low granularity: "Dissolve drug in solvent and filter."
2. High granularity: "Weigh 100 g of API, dissolve in 500 mL ethanol (99.9% purity) at
25 ± 2°C using magnetic stirrer at 300 rpm for 15 minutes, then filter using 0.45 µm
membrane.“
Note: High granularity ensures the new team can exactly repeat the steps.

11. THANK YOU