STANDARD OPERATING PROCEDURE INPROCESS CONTROL OF MANUFACTURING OPERATION

                                         STANDARD OPERATING PROCEDURE

SUBJECT :                     INPROCESS CONTROL OF MANUFACTURING OPERATION

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

1.0       OBJECTIVE:

To provide guidelines for in-process Control to ensure that manufacturing operations are carried out as per the laid down procedures adhering to cGMP.

2.0       SCOPE:

To monitor the process of manufacturing of product, and In-process checking by QA executive

3.0       PROCEDURE:

3.1       In-process control will be done as a spot check to audit the manufacturing operations.        

3.2       It will be done by Executive / Jr. Executive in manufacturing areas.

3.3       Thorough cleaning of machinery and equipment prior to use and removing of previous batch remnants for proper performance.

3.4       All log books are updated online.

3.5       Storage of raw material, granules, batch wise segregated in appropriate containers (properly labeled).

3.6       Manufacturing operations are carried out strictly as per the directions listed in BMR and the recordings are done online.

3.7       Any discrepancies observed will be informed to G.M (Q.A) for corrective Action through Production Manager.

3.8       All observations shall be recorded in the prescribed formats & reviewed by G.M (Q.A).

3.9       Sampling of bulk product is done and certain critical parameters are checked by QA. If the bulk meets the limits specified it will be approved for packing and an inprocess analytical report is prepared in the prescribed format for record purpose. This is done for DRL only.

4.0       FREQUENCY: Daily/ as and when required.

5.0       RESPONSIBILITY: Executive QA.

6.0       REVIEW GUIDE: Manufacturing records.

7.0        ANNEXURE:

                                     

             1. Quality assurance daily inspection record for filling &finishing.

                            2. Filling & finishing inspection.

1.      Status labels.

2.      Inprocess analytical report format.

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

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