Attachment-1

General details

Form no. Issued by

Issue to: Date:
Product0item:
Batch no./ lot no.:
Stage:
Out of Specification Test:
Analyzed by:_____________________ date :_______________Reference:_____________

Details of Investigation

Stage A

Sr. no. item observation sign

Condition of sample to
be checked
Balance checked for
its calibration
Instrument Calibration
checked.
Volumetric standard /
reagent used for
analysis checked for
its validity.
Analytical
template/Hard book
checked for dilution,
calculation, weighing
Titer values and
readings.
Working standard
checked for its
validity.
Chromatograms /
printouts / TLC plates
checked
Glassware checked for
its accuracy and
Calibration.
Remark of the investigator: Not Satisfactory/ Satisfactory
Sign: __________ Date: __________
Stage B
Repeat analysis allotted to:
Date:
Observation of the result:
 Analysed By: __________ Date: __________ Reference: __________

Remark of the investigator:

Sign: __________ Date: __________

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.

MATERIAL /PRODUCT RESAMPLE AUTHORIZATION FORM

AR No.: Quantity: Authorization Sampled By/Date:

By/Date:

Stage C
Name of senior Chemist: Date of Analysis:
Approved batch taken for comparison
Observation of the result:

Approved batch:

Current batch:

Analyzed by: ______________ Date: ___________ Reference: _____________________

FINAL CONCLUSION:
Quality Head: _______________ Date:___________________

Attachment-2

OOS APPLICABLE OOS NOT APPLICABLE

Sr. No. TESTS of Releasing Parameters Sr. No. TESTS of Informative Parameters
1. Identification 1. Description
2. Assay 2. Particle Size Distribution (Sieve tests)
3. Related Substances / Chromatographic 3. Bulk Density
purity / Degradation 4. Physical parameters (i.e. Hardness,
4. profiles. Friability,
5. Solubility 5. dimensions)
6. Dissolution (USP guidelines to be
followed)
7. Content Uniformity (USP guidelines to
be followed.
8. Chemical purity tests (i.e. Melting
points/ Colour index,
9. chlorides/ sulphates, SOR, etc)
10. Text matters, Grammage, Colour
scheme.