STANDARD OPERATING PROCEDURE ANALYTICAL RECORDS

    STANDARD OPERATING PROCEDURE

SUBJECT:                      ANALYTICAL RECORDS

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP VERSION            :

1.0       OBJECTIVE:

To provide guidelines for preserving Analytical records of raw material, In-process checks and finished products.

2.0       SCOPE:

To maintain all Analytical records for reference.

3.0       PROCEDURE:

3.1          After analysis, all the values, readings and calculations will be recorded in respective register/records.

3.2       In-process checking details will be entered in “In-process Reports”.

3.3       The details of analysis for finished products will be entered in “Finished Product Analytical Records and Report”.

3.4       Separate Register will be maintained for different Principals.

3.5       All the pages of the Register will be numbered.

3.6                   The reports issued by public laboratory for testing done by them are attached to the main report.

3.7.      The reports related to Microbiological testing are attached to the concerned product report.

3.8       The records and reports are signed off by the analyst, reviewed by executive and finally by approved analyst.

4.0       FREQUENCY:  Regular basis

5.0       RESPONSIBILITY: G.M (Q.A).

6.0       REVIEW GUIDE: Respective Analytical record/ Analytical Reports

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x