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