Procedure for review and approval of analytical raw data

 

1.0 OBJECTIVE

To lay down a procedure for review and approval of Analytical Raw Data

2.0 RESPONSIBILITY

Quality Control Chemist / Quality Control Executive

3.0 ACCOUNTABILITY

Quality Control Manager

4.0 PROCEDURE

4.1 The reviewer shall ensure the following at the time of reviewal of the documents.

4.1.1 All the relevant details of the tested material.

4.1.2 Correct and Current Specification No.

4.1.3 All the tests are performed as per the required specifications.

4.1.5 Correct use of working standard and its potency along with AR.No.

4.1.6 Correct use of HPLC columns.

4.1.7 All print- out chromatograms duly signed and dated by the Analyst should be attached.

4.1.8 The raw data shall contain the Instrument No, used for the analysis.

4.1.9 Correct Normality is used.

4.2 Correct Karl Fischer factor is used.

4.2.1 Correct units for measurements are mentioned.

4.2.2 The reviewer shall also ensure for the following,

4.2.3 Rounding off the results is done.

4.2.4 Correctness of the calculations.

4.2.5 Justifications for discarding the data (if any)

4.2.6 After going through the above mentioned requirements, the reviewers shall put his Signature
and date on the raw analytical data.

5.0 ABBREVIATIONS

AR.No.- ANALYTICAL REFERENCE NUMBER

6.0 REFFERENCES

NIL