STANDARD OPERATING PROCEDURE MAINTAINING LABORATORY NOTE BOOKS

 STANDARD OPERATING PROCEDURE

SUBJECT:                      MAINTAINING LABORATORY NOTE BOOKS

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

1.0       OBJECTIVE:

           

To provide guidelines to maintain Laboratory note books.

1.0                           POLICY:

Maintaining laboratory books is an important part of cGMP.

3.0       PROCEDURE:

3.1                   Raw material / Packing material/ finished product / bulk product register are maintained product wise or Company wise.

3.2       Following details are available in the register and report of each Raw material tested.

3.2.1    Name of the material                           3.2.9    Name of the Mfg./Supp.

3.2.2    Batch no.                                             3.2.10 Shipment condition.

3.2.3    Date of Mfg.                                        3.2.11 Date of sampling.

3.2.4    Date of Exp.                                        3.2.12 Sampled by.

3.2.5    Total Qty received                               3.2.13 Date of Analysis.

3.2.6    No. containers recd.                             3.2.14 Date of Retest.

3.2.7    Date of receipt.                                                3.2.15 Analytical details with calculations.

3.2.8    Q.A No.                                               3.2.16  Remarks and Sign.

                                   

            3.3       The following details are available for each finished product, Bulk, In process material analyzed:

           

3.3.1    Name of the Product

3.3.2    Batch No.

3.3.3    Batch size

3.3.4    Mfg date

3.3.5    Exp date

3.3.6    Stage at which sampled

3.3.7    Date of sampling/sampled by

3.3.8    Analytical details with calculations

           

3.3.9    Date of Analysis

3.3.10 Remarks and Sign of Q.A Staff with date

3.4       Over writing shall not be allowed. If any correction is to be made it should be done by striking out with a single line over it and signed off.

All the books are properly numbered and preserved. The results in the books are signed off by the analyst, checked by second analyst and approved by the QA Manager.

4.0       FREQUENCY: As and when required.         

5.0       RESPONSIBILITY: G.M (Q.A).

6.0       REVIEW GUIDE: Lab note books and 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