STANDARD OPERATING PROCEDURE INPROCESS QUALITY CHECKS AND SAMPLING

STANDARD OPERATING PROCEDURE

SUBJECT :                     INPROCESS QUALITY CHECKS AND SAMPLING

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

1.0       OBJECTIVE:

                                                                                                                                               

To provide guidelines for various in-process checks and online sampling for Finished Products       

2.0       POLICY:

To lay down a procedure for In process quality checks and sampling.

                       

3.0       PROCEDURE:

In-process check is a part of QA functions and checking is done at various stages of manufacturing

3.1       TABLETS

3.1.1    Moisture content of unlubricated granules is checked for each and every lot.

3.1.2    During compression the following parameters are checked for

            (a) Description (b) Average weight (c) Thickness (d) Size of Tablet (e) Disintegration time

(f) Friability

Sampling of tablets is done at regular intervals during Compression and the sample is pooled for analysis.

3.1.3    While packing the following parameters are checked for

            -Correctness of coding Details on foil and Carton.

            -Defective Strips are sorted out.

            -Coding details of the Carton and Foil are to match.

            -Correctness of Packing.

            -Proper Sealing.

           

-Leak test in case of Aluminium Strip packing

Online Sampling of Strips is done at regular intervals for Control Sample

                                                                                                                       

3.2       LIQUIDS

3.2.1                During sampling the correctness of the batch quantity manufactured is checked with the help of Dip  

           rod.

3.2.2   The Product is sampled for analysis.

3.2.3   During filling the following parameters are checked for

            -Cleanliness of the Bottle.

                       

            -Proper sealing.           

            -Correctness of the filled volume.

           

            -Correctness of packing and sealing.

           

            -Any particulate matter contamination.

            -Correctness of coding details on Product label.

Online sampling of bottles is done at regular intervals for control sample.                 

3.3       CREAMS, OINTMENT, LOTION:

3.3.1     During sampling the correctness of the Batch quantity is checked.

3.3.2     During filling operations the following parameters are checked for

            -Cleanliness of the tube or bottle.

            -Correctness of filled weight or volume.

            -Proper crimping or sealing.

            -Correctness of coding details on the tube, carton outer & inner and outer label.

            -Correctness of Packing and Sealing.

Online sampling of tubes and bottles are done at regular intervals for Control samples

4.0       FREQUENCY: As and when Finished Product is manufactured.

5.0       RESPONSIBILITY: Executive Q.A.

6.0       REVIEW GUIDE:  In process record sheets.

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	√
Warehouse	x	x
General	x	x
Maintenance	x	x