Out of Specification Report (OOS)

 

    

 

Date

Time

Product Name

Batch No

Deviation/OOS No

Stage A

Sr #

Parameters to be Inspected

Results

1.

Condition of sample to be checked.

2.

Balance checked for its calibration.

3.

Instrument Calibration checked.

4.

Volumetric standard / reagent used for analysis checked for its validity.

5.

Analytical template/Hard book checked for dilution, calculation, weighing Titer values and readings

6.

Working standard checked for its validity.

7.

Chromatograms / printouts / TLC plates checked

8.

Glassware checked for its accuracy and Calibration.

Remarks of the QAI

Satisfactory

Not Satisfactory

Sign of QAI:

Dated:

Stage B: Repeat Analysis

Date of repeat Analysis

Observations:       Analyzed By

Remarks of the QAI

Sign Dated

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

Sample #

Authorized By

Sample Qty

Sampled By

Stage C

Name Of Senior Analyst

Date of Analysis

Approved batch taken for comparison

Observations

Approved Batch (%age Assay)

Current Batch (%age Assay)

Final Conclusion

%age Assay Result of stage A

%age Assay Result of stage B

%age Assay Result of stage C

OOS Applicable to the following tests

OOS Not Applicable to the following tests

Tests of Releasing Parameters

Tests of Informative Parameters

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)

QA Officer

QA Manager