SOP FOR SAMPLING, TESTING AND RELEASE OF PACKING MATERIAL

1. OBJECTIVE:

1. To lay down the procedure for the Sampling, Testing & Release of Packing Material.

2. SCOPE: 

1. This procedure is applicable for the Sampling, Testing & Release of Packing Material.

3. RESPONSIBILITY:

1. Quality Control officer / Executive are responsible for sampling & testing and follow procedure as per the procedure mentioned in this SOP. 

2. QC Head is responsible for Approval & Release and implementation and compliance of the procedure as per this SOP.

4. ABBREVIATIONS

1. SOP    :    Standard Operating Procedure

2. QC    :    Quality Control

3. GRN    :    Goods Receipt Note

4. AR No.    :    Analytical Reference Number

5. SS        :    Stainless Steel

6. PVC    :    Polyvinyl Chloride

7. COA    :    Certificate of Analysis

5. PROCEDURE: 

1. Preparation For Sampling: 

1. Receipt of material in warehouse shall be intimated to quality control through “Goods Receipt Note (GRN)”.

2. QC chemist enters the GRN details in Inward Record for Packing Material in Packing Material

3. Inward Register as per Annexure –I.

4. Sampling Plan 

1. To ensure representative sampling, open randomly selected containers and follow the sampling plan as below :

Sr. No.	MATERIAL CATEGOTY	Number of Units per case	Sample Size
1.	Printed Mono cartons/ Outer Cartons/ leaflets /Printed labels , (printed or non printed),	Below 1200	25
		1,201    -    3,200	50
		3,201    -    10,000	80
		10,001    -    35,000	125
		35,001    -    150,000	200
		150,001    -    500,000	315
2.
3.
4	Shipper	--	1% of the received quantity

2. Inspect the sampled quantity of printed packing material thoroughly for :

1. Uniformity amount the lot.

2. Printed matter clarity, correctness.

3. Colour shade.

4. Text matter.

5. Cleanliness.

6. Appearance.

7. Description.

3. And inspect the sampled quantity of unprinted packing materials thoroughly for :

1. Cleanliness.

2. Appearance.

3. Description.

4. Before proceeding to sampling ensure that the sampling kit consists of :

1. SOP for sampling.

2. Sampling checklist record.

3. GRN of the material.

4. Sampling tools (like scissors, SS scale, clean polythene bags, BOPP Tape, rubber band, etc.).

5. “Sample For Analysis” Label.

6. “Sampled By” Label.

2. Execution of Sampling:

1. Proceed to the stores along with the sampling kit and GRN.

2. Enter into the ware house through the change room as per the SOP for procedure for Entry and exit. 

3. Inform the concerned stores person and request to arrange the materials for sampling.

4. Physically verify the consignment details along with that given in GRN.

5. In case of any discrepancies note that in sample inspection report by LIMS/Pharmasuite  and call the attention of QA Manager. Report such discrepancy into the sampling remark sheet as generated by LIMS/ Pharmasuite.  

6. In case of primary packing materials use the SS table provided in the quarantine area for sampling, handle PVC foil, tubes and printed aluminum foil separately.

7. Packing material sampling is done at the respective quarantine area.

8. Keep the PVC/ printed aluminum foil & other printed packing material in the original polythene bags after sampling. Keep the tube in original container.  

9. Samples are collected in the plain polythene bags.

10. Ensure the relevant details in the “sample for analysis” label and affix on the sample bag.

11. Indicate the observation in the sampling remarks sheet.

12. Affix the status label “Sampled By” on all the container/ pack sampled.

13. Close the original container after sampling.

14. Keep all the sampling aids, sample bags along with the sampling tools in the sampling kit and take it to the QC Laboratory. 

3. Testing And Release:

1. The AR No. to samples (for each batch) shall be given as per procedure .

2. Analyze the samples as per respective Standard Testing Procedure.

3. After the analysis the test results are entered in the Test Data Sheets as per Annexure –II.

4. The Test data sheet format consists of the following information in the respective cells of the format as given below.

Cell Number	Information
01	To write the name of material
02	To write reference /Specification no.
03	To write GRN number
04	To write the A.R. No.
05	To write the Batch No./Lot no.
06	To write the Material code
07	To write received quantity
08	To write the sample quantity
09	To write the sample by/on
10	To write Retest date
11	To write the date of analysis
12	To write the date of release

5. An authorized person should check all the calculation and ensure that all the tests are performed as per the specifications.

6. Finally the test report is checked & approved by Manager Quality Control/his designee.

7. Affixed “Approved / Rejected” labels or stamp to all containers of the consignment to ensure 100% labeling with followed the entry & exit procedure in warehouse.

8. The status of analysis is indicated in GRN.

9. Update the test status in “Inward Record for Packing Material”.