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Stability Data Trending Template

The document is a standardized template for compiling and trending stability data for bulk Type B bovine-hide gelatin pellets, supporting the Data Trending & Statistical Evaluation SOP. It includes sections for document identification, CQA trend tables, graphical trend placeholders, statistical summaries, and flags for out-of-trend (OOT), out-of-specification (OOS), and excursions. Additionally, it provides a cross-CQA comparison summary and comments from QC and QA for trend assessment.

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Turiyo Anthony
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37 views4 pages

Stability Data Trending Template

The document is a standardized template for compiling and trending stability data for bulk Type B bovine-hide gelatin pellets, supporting the Data Trending & Statistical Evaluation SOP. It includes sections for document identification, CQA trend tables, graphical trend placeholders, statistical summaries, and flags for out-of-trend (OOT), out-of-specification (OOS), and excursions. Additionally, it provides a cross-CQA comparison summary and comments from QC and QA for trend assessment.

Uploaded by

Turiyo Anthony
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

TIANRAN BIOTECH (U) LTD

STABILITY DATA TRENDING TEMPLATE


Controlled Document — Phase 4 Supporting Template
Purpose: Standardized template for compiling and trending stability
data for bulk Type B bovine-hide gelatin pellets. This template
supports the Data Trending & Statistical Evaluation SOP and ensures
NDA-defensible presentation of results. No specifications or
analytical methods may be inserted.

1. DOCUMENT IDENTIFICATION
 Trending Template ID: [Assign]
 Product: Bulk Type B Gelatin Pellets
 Batch Number: [Insert]
 Study Type: Long-Term / Accelerated / Stress / Ongoing
 Protocol Number: [Insert]
 Prepared By (QC): [Insert]
 Reviewed By (QA): [Insert]

2. CQA TREND TABLES


Populate a separate table for each CQA.

2.1 Appearance Trend Table


Notes
(Deviations/OOT/Ex
Timepoint Result cursions)
[t0] [Insert] [Insert]
[t1] [Insert] [Insert]
[t2] [Insert] [Insert]

2.2 Moisture Trend Table


Result (% Change vs
Timepoint w/w) Initial Notes
[t0] [Insert] 0 [Insert]
[t1] [Insert] [Insert] [Insert]
2.3 Microbiological Quality Trend Table
Timepoint Result Method Ref Notes
[t0] [Insert] [Insert] [Insert]
[t1] [Insert] [Insert] [Insert]

2.4 Bloom Strength Trend Table


Result (g Change vs
Timepoint Bloom) Initial Notes
[t0] [Insert] 0 [Insert]
[t1] [Insert] [Insert] [Insert]

3. GRAPHICAL TREND PLACEHOLDERS


Attach plots generated per SOP. (No colors specified—style determined by
QC.)

3.1 Appearance Trend Plot


[Insert image]

3.2 Moisture Trend Plot


[Insert image]

3.3 Microbiological Quality Plot


[Insert image]

3.4 Bloom Strength Trend Plot


[Insert image]

4. BATCH-OVERLAY TREND TABLE


CQA Batch Timepoint Result Notes
Moisture Batch 1 [Insert] [Insert] [Insert]
Moisture Batch 2 [Insert] [Insert] [Insert]
Bloom Batch 1 [Insert] [Insert] [Insert]
5. STATISTICAL SUMMARY (ICH Q1E ALIGNED)
 Model selection applied: [Linear / Non-linear / No model]
 R²: [Insert]
 Slope: [Insert]
 Residuals review: [Insert]
 CI assessment (95%): [Insert]
 Interpretation: [Insert]
If regression not suitable:
“Regression not used due to variability/poor fit; data bounded to last valid
timepoint.”

6. OOT / OOS / EXCURSION FLAGS


6.1 OOT Flags
Deviation Investigation
Timepoint CQA Description Ref

6.2 OOS Flags


Investigation
Timepoint CQA Result Ref

6.3 Excursion Flags


Impact
Type Date Duration Summary Ref

7. CROSS-CQA COMPARISON SUMMARY


Describe any inter-parameter correlations: - Moisture vs Bloom relationship:
[Insert] - Appearance vs Moisture: [Insert] - Microbiological quality vs
Moisture: [Insert]

8. QC SUMMARY COMMENT
[Insert high-level QC interpretation of trends]

9. QA REVIEW COMMENT
[Insert QA assessment of trend validity and any required actions]
10. STABILITY COMMITTEE NOTES
[Insert committee decisions where applicable]

END OF STABILITY DATA TRENDING TEMPLATE

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