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Date |
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Time |
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Product Name |
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Batch No |
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Deviation/OOS
No |
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Stage A |
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Sr # |
Parameters to be Inspected |
Results |
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1.
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Condition of sample to be checked. |
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2.
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Balance checked for its calibration. |
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3.
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Instrument Calibration checked. |
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4.
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Volumetric standard / reagent used for analysis checked
for its validity. |
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5.
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Analytical template/Hard book checked for dilution,
calculation, weighing Titer values and readings |
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6.
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Working standard checked for its validity. |
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7.
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Chromatograms / printouts / TLC plates checked |
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8.
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Glassware checked for its accuracy and Calibration. |
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Remarks of the QAI |
Satisfactory |
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Not Satisfactory |
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Sign of QAI: |
Dated: |
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Stage B: Repeat Analysis |
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Date of repeat
Analysis |
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Observations: Analyzed By |
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Remarks of the QAI |
Sign Dated |
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Note: If the
material fails in the above stage i.e. Stage B, the material will resample
with the authorization shall be Analyzed by Senior analyst along with the
previously approved material. |
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MATERIAL /PRODUCT RESAMPLE AUTHORIZATION
FORM |
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Sample # |
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Authorized By |
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Sample Qty |
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Sampled By |
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Stage C |
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Name Of Senior Analyst |
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Date of Analysis |
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Approved batch taken for comparison |
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Observations |
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Approved Batch (%age Assay) |
Current Batch (%age Assay) |
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|
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Final Conclusion |
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%age Assay Result of stage A |
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%age Assay Result of stage B |
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%age Assay Result of stage C |
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OOS Applicable to the following tests |
OOS Not Applicable to the
following tests |
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Tests of Releasing
Parameters |
Tests of
Informative Parameters |
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|
I.
Identification
II.
Assay III.
Related Substances (Chromatographic purity / Degradation
profiles). IV.
Solubility
V.
Dissolution (USP guidelines to be followed) VI.
Content Uniformity (USP guidelines to be
followed. VII.
Chemical purity tests (Melting points/ chlorides/ sulphates, ) VIII.
Text matters, Grammage, Color scheme. |
I.
Description
II.
Particle Size Distribution (Sieve tests) III.
Bulk Density IV.
Physical parameters (Hardness, Friability, dimensions) |
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QA Officer |
QA Manager |
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