Laboratory Raw Data Management and Control

 

1.0           Purpose

1.1            To lay down a procedure for proper issue, control, recording and review of analytical documents to ensure accuracy, before releasing the product/ material.   

2.0           Scope

2.1         This procedure is applicable for review of raw data and supporting documents related to Quality Control Analysis.

3.0           Responsibility

3.1            Quality Control (QC) Sr. Officer /Officer/Analyst is responsible for following the SOP

3.2            Head of Quality Control is responsible for the implementation of this SOP.

3.3            Head of Quality Assurance is responsible for compliance of the SOP.

 

4.0           Abbreviations and Definitions

4.1            SOP     : Standard Operating Procedure

5.0           Materials and Equipment

5.1            None

6.0           Precaution / Health and Safety Considerations

6.1            None

 

7.0           Procedure

7.1            Issuance & control of analytical reports:

7.1.1        For the issuance & control of analytical reports follow the standard procedure.

7.2            Recording results:

7.2.1        Record all weight, dilution details on analytical report.

7.2.2        All entry on record of analysis shall be recorded in blue ink only.

7.2.3     All chromatograms, UV spectrum, UV absorbance print, IR spectrum, shall be attached with analytical report.

7.3            Review of documents:

The reviewer shall ensure for the following at the time of reviewing the documents:

7.3.1        Details of analysis recorded on analytical report shall be legible.

7.3.2        Specification number is correct and current.

7.3.3        All the tests as per the specification are performed.

7.3.4        Correct use of standard and its potency along with QC Ref. No./Batch No. of standard used.

7.3.5        Correct use of HPLC columns.

7.3.6        All print-out, chromatograms duly signed and dated are attached with analytical report.

7.3.7        Correct normality is used.

7.3.8        Correct K.F factor is used.

7.3.9        Correct units of measurements are mentioned.

7.3.10      No overwriting and use of erasing fluid.

7.3.11      Cross outs are initialed and dated along-with justification wherever applicable.

7.3.12      Rounding off' of the results is done as per respective SOP  “Rounding off Analytical Results".

7.3.13      Signature of analyst(s) and date wherever applicable.

7.3.14      Correctness of calculations.

7.3.15      Correctness of transfer of data from analytical report to other relevant documents  and Certificate of Analysis.

7.3.16      Justification for discarding the data (if any) is recorded or not.

7.3.17       Irrelevant test(s) and blank space on analytical report is stricken out.

7.4          After going through the above mentioned requirements, the reviewer shall put  his / her signature and date on analytical report.

7.5            Deviation observed in the review is reported to the Manager and Head of QC/ Manager QA. Corrective actions including retraining of analyst / officer concerned shall be ensured by the Manager QA.

 

 

8.0           Reference Document

8.1            In-house

 

9.0           Annexure

9.1            None

10.0        Revision History

 

Revision No.	Brief reason for the revision	Effective Date	Remarks
01	New

 

11.0        Training

11.1       Head of Quality Control or his/her nominee shall give the SOP training before effective date.