STANDARD OPERATING PROCEDURE SAMPLING OF PACKING MATERIAL

STANDARD OPERATING PROCEDURE

SUBJECT :                     SAMPLING OF PACKING MATERIAL

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

1.0                OBJECTIVE:

To provide guidelines for sampling of packing materials.

2.0                SCOPE:

To lay down a procedure for sampling of packing material.

3.0       PROCEDURE:  

3.1       The stores/warehouse executive will inspect the truck in which PM’s are received. The WH executive will collect the documents received for the consignment and will cross check the details available. If the details and documents are clear then the materials will be unloaded and stacked in appropriate area.

3.2       Warehouse will prepare GI note on the receipt of materials and send the same to QA, in attached format General inward report Annexure-1 Sop No.06/QA.

3.3       QA Executive will enter the details of the GI Note in the packing materials QC Register and allot QA No.

3.4       Check the shipment condition and cleanliness of packets/cases received before sampling.

3.5       Check for correct identification of packets/ cases and component tags fixed by warehouse.

3.6       In case of bulk packing items like bottles, jars etc., draw the samples from different packs as

            specified under the attached statistical sampling chart. Annexure- 2, SOP No 06/QA.

3.7       On completion of inspection by Executive QA, the sampled packs are placed back, duly wrapped and sealed to the respective containers.

3.7       After inspection under test label is pasted by Executive QA which has the following details

     material name, QA. No. GI No. sign date.

3.8        After inspection the material is sampled an under test label and sampled labels are pasted on the

     container. The sampling of the consignment is cross checked by a senior who initials on the

      sampled container and on the inspection report.( This is for DRL consignments only)

           

3.10.    The sample is tested by Executive QA. The samples are tested as per SOP No: 08/QA.

3.11     Wear head gear, nose mask & gloves before sampling.

3.12        Sanitize hands with 70% IPA and for sampling of micro sensitive packing materials, use clean & sanitized sampling tools, for sampling micro sensitive packing material. Use 70 % IPA for sanitizing the sampling tools.

3.13     For micro sensitive packing materials like pet bottles, sachet laminates and caps are to be sampled with utmost care to avoid contamination.

3.14     The sampling of micro sensitive packing material will be done by microbiologist with the aid of Lab assistant and take necessary precautions to avoid touching of inner surface of packing materials. Check the integrity and any damaged/unsealed packs to be identified and segregated.

3.15     Caps are sampled with sanitized scoop. Laminates are sampled using sanitized blades/cutters, discard first few layers and subsequent sample is to be drawn for testing. Sampled bottles, caps and laminates are collected into fresh separate polythene bags and are tested on the same day. 

3.16     Carry out the microbiological testing as per SOP or as per  microbiological test procedure for micro sensitive packing materials

4.0       FREQUENCY: As and when required.

5.0       RESPONSIBILITY: Executive QA/Microbiologist.

6.0       REVIEW GUIDE: ------

7.0       ANNEXURE:

1.      General Inward format.

2.      Statistical sampling chart.

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