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Project Identification No. |
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Name
of Product: |
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Technology Sending Coordinator: |
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Technology
Receiving Coordinator (Proposed site) |
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ALSO READ:Â SOP for Product Transfer to the Manufacturing Site
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Sr. |
Activity / Documents |
Responsible person |
Probable Target date |
Sent on |
Sent by |
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1 |
Product
Developmental report |
Coordinator |
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2 |
Master
Manufacturing Record / Batch manufacturing record (Executed) |
Coordinator |
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3 |
Master
Packing Record / Batch packing record (Executed). |
Coordinator |
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4 |
Tooling
Specification |
Coordinator |
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5 |
Process
Validation Protocol & Report |
Coordinator |
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6 |
Product
Cleaning Method – Protocol & report |
Coordinator |
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7 |
Specification,
STP & MSDS of Active Material(s) |
Coordinator |
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8 |
Specification,
STP & MSDS of Inactive Material(s) |
Coordinator |
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9 |
Specification,
STP & MSDS of Packaging Material(s) |
Coordinator |
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ALSO READ:Â Analytical Method Validation Protocol for Nystatin
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10 |
Specification, STP of In-process
product(s) |
Coordinator |
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11 |
Specification,
STP & MSDS of Finished product (s) |
Coordinator |
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12 |
Analytical method validation Protocol &
Reports (Finished product) (as applicable) |
Coordinator |
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Assay, |
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Related substance, |
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Content
Uniformity, |
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Dissolution profile, |
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OVI,
Residual Solvents |
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Stability indicating Method. |
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13 |
Analytical
method validation Protocol & Reports/ Method transfer protocol of
Critical API for (as applicable) |
Coordinator |
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Assay, |
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Related
substance, |
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OVI, Residual Solvents |
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14 |
Trend
data for last 10 batches of |
Coordinator |
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API bulk density |
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API
Particle size. |
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API Solubility profile. |
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Excipient’s
bulk density |
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Excipient’s Particle size. |
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Finished
product trend analysis data |
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15 |
Finished Product Samples (3 batches) |
Coordinator |
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16 |
Product
Stability Data |
Coordinator |
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17 |
Annual Product Review |
Coordinator |
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18 |
Approved
Vendor List |
Coordinator |
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19 |
Audit Report of vendors (Manufacturer) |
Coordinator |
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20 |
Product
History (Critical product problems) |
Coordinator |
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21 |
Complaint History and Investigation report |
Coordinator |
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22 |
Change
control / History of product. |
Coordinator |
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23 |
Technical Agreement |
Coordinator |
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24 |
Access
letters / Marketing authorization |
Coordinator |
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25 |
Dossiers transfer letters. |
Coordinator |
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26 |
Country’s
FDA approval letter |
Coordinator |
