SOP Title: Sampling, Analysis and Release or Rejection of Packing Materials
- Objective:
To lay down the procedure for Sampling, Analysis and Release or Rejection of Packing Materials.
- Scope:
This procedure is applicable for Sampling, Analysis and Release or Rejection of Packing Materials in Quality Control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Sampling, Analysis and Release or Rejection of Packing Materials in Quality Control Department as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexures.
- Warehouse Department: To intimate Quality Control Department for Sampling of Packing Materials.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department
- Procedure:
| 5.1 | Precautions of Sampling Containers: | |
| 5.1.1 | Use clean self sealing polyethylene bags for primary and secondary packing materials. | |
| 5.1.2 | Sampling analyst should wear safety nose mask, gloves at the time of sampling. | |
| 5.1.3 | Sample only one container/roll/box at a time in a packing material sampling area. | |
| 5.2 | Receipt and Planning of sampling: | |
| 5.2.1 | Verify documents like GRN, party COA, supplier challan or invoice from warehouse. | |
| 5.2.2 | If the documents are correlated to each other; the sampling analyst or supervisor shall enter all details in “Packing Material Inward Register” as per Annexure and assign the Analytical Reference Number and plan for sampling. | |
| 5.2.3 | Assign Analytical Reference Number (A. R. No.) as “PM/YY/NNN”
Where, ‘PM’ stands for ‘Packing Material’ ‘YY’ stands for ‘Last two digits of the current year’ ‘NNN’ stands for ‘Serial number’ i.e. 001, 002 and so on. |
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| 5.2.4 | If the receipt documents and consignment miss match to each other then sampling analyst should report to Supervisor, Executive or Quality Control Head. If needed necessary correction shall be done on the document from Warehouse person after consultation with Quality Control Head. | |
| 5.2.5 | Sampling analyst should accompany necessary sampling aids like –Sampling polybags, tie rope, gloves, nose masks, pen marker etc. and accessories like –cutter, scissor knife, tape etc. | |
| 5.2.6 | Arrange the rolls/containers as per lot /batch number and fill required information in the “Packing Material Sampling and Visual Inspection Report” as per define Annexure. | |
| 5.3 | Visual Inspection Procedure: | |
| 5.3.1 | Select the batch or lot size of the consignment received as per Table no. 01– ‘Packing Material Visual Inspection Plan’. | |
| 5.3.2 | Check the sample size code letter from the ‘general inspection level’ column for the same batch or lot size in Table no. 01. | |
| 5.3.3 | Check the number of containers/rolls/boxes to be inspected from the ‘sample size’ column in Table no. 01. | |
| 5.3.4 | Example: If one consignment is received with batch size of 400 rolls, then as per Table no.01, the sample size code letter is ‘H’ and number of rolls to be inspected is 50. | |
| 5.3.5 | During inspection if any defects found then categorize the defects as critical, major and minor as mentioned in Table No. 02 – ‘Class of Defects’. | |
| 5.3.6 | Defects categories are divided based on criticality to product quality and each defect class is assigned with different AQL level. | |
| 5.3.7 | Refer Table No. 01 for acceptance or rejection of Packing Materials having defects. | |
| 5.3.8 | Example:
If one consignment is received with batch size of 1000 cartons, then as per Table no.01, the sample size code letter is ‘J’ and number of cartons to be visually inspected is 80. During inspection if some cartons are found with shade variation defect then categorise the defect as per Table No. 02. AQL limit for shade variation is 4.0%. According to the sample size, if 6 or more than 6 cartons are found with shade variation defect then the consignment should be rejected. If 5 or less than 5 cartons are found with shade variation defect then the consignment should be accepted (Refer Table No. 01).
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| Table No. 02 Class of Defects | ||
| Defect Class | Description | AQL |
| Critical | Artwork Code number, damaged rolls, Contamination of glass bottles/vials with insects. | 0.010% |
| Major | pin holes, Ink spreading on cartons, Printed matter not clear | 0.65% |
| Minor | Shade variation, Winding of rolls, grease on the bottle, double code on the label, Uneven outer surface or wavy appearance of glass bottles/vials, dust or any foreign matter. | 4.0% |
| Table No. 03 Sample Quantity for Analysis and Control Sample | ||||
| Sr. No. | Name of the Packing material | Sample quantity | Total Sample quantity | |
| For Analysis | Control Sample | |||
| 1. | PVC | 1 meter | 1 meter | 2 meter |
| 2. | PVDC | 1 meter | 1 meter | 2 meter |
| 3. | Printed Foil | 1 meter | 1 meter | 2 meter |
| 4. | Printed Aluminium tubes | 05 | 01 | 06 |
| 5. | Vials/Bottles | 05 | 01 | 06 |
| 6. | Printed cartons | 05 | NA | 05 |
| 7. | Labels/Stickers | 05 | NA | 05 |
| 8. | Inserts/Leaflets | 01 | NA | 01 |
| 9. | Silica pouch | 01 | NA | 01 |
| 10. | Shippers/Corrugated boxes | 01 | NA | 01 |
| 11. | Polybags/ Printed bags | 01 | NA | 01 |
| 12. | HDPE/ Plastic Containers | 01 | NA | 01 |
| 5.4 | Sampling of Primary Packing Materials: | |
| 5.4.1 | Check the cleaning of Primary Packing Sampling room for dust. The Primary Packing Sampling room shall be cleaned with wet mop followed by dry mop. | |
| 5.4.2 | During sampling use the clean accessories and cover the material with fresh polythene. | |
| 5.4.3 | Material shall not be contaminated, because it will come into direct contact with product and can affect the product quality. | |
| 5.4.4 | Check the full consignment as per GRN for batch or lot number, quantity, and any external damages at quarantine area. After successful verification and numbering of the containers, boxes to be moved inside the primary packing room one at a time. | |
| 5.4.5 | Refer Table No. 03 for individual sample quantity for analysis and control samples. | |
| 5.4.6 | Take samples for visual inspection as per sample size mentioned in the Table no. 01. | |
| 5.4.7 | Make pool sample by mixing all samples which are collected for visual inspection and randomly pull out samples for analysis as per Table No. 03. | |
| 5.4.8 | Example 1: If one consignment is received with batch size of 03 boxes of PVC rolls, then as per Table no.01, the sample size code letter is ‘A’ and number of rolls to be visually inspected and sampled is 02. | |
| 5.4.9 | Example 2: If one consignment is received with batch size of 200 PVC rolls, then as per Table no.01, the sample size code letter is ‘G’ and number of rolls to be visually inspected is 32. From these number of rolls to be sampled for analysis is 02 as per Table No. 03. |
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| 5.4.10 | Primary Packing Materials like PVC, PVDC, Aluminium plain foil and printed foil should be checked for shade, winding of the role should be uniform and without any folds within the layers, pin holes if any. | |
| 5.4.11 | If any discrepancy observed then immediately bring it to the notice of the supervisor. | |
| 5.4.12 | If no defects are found then draw the sample after discarding initial 2-3 meters. Initial 2-3 meters sample should be shredded or cut into 10 to 15 pieces and shall be sent to scrap yard for disposal. | |
| 5.4.13 | After Sampling completion, affix “UNDER TEST” (yellow colour) label on all containers. | |
| 5.4.14 | After sampling of packing material, clean primary packing room and Analyst should fill details on “Usage and Cleaning Log of Primary Packing Room” Annexure. Keep the sample for analysis in a designated place in Quality Control Laboratory with proper labeling. | |
| 5.4.15 | Analyst should refer Standard Testing Procedure to ensure that all required reagents, chemicals, accessories, equipment or instruments are standardised or validated and available in the laboratory. | |
| 5.4.16 | Analyst should fill in the necessary details on the Analytical Work Report according to “Packing Material Inward Register” and start the analysis as per standard testing procedure and specification. | |
| 5.4.17 | Ensure that all the instruments are calibrated before use. | |
| 5.4.18 | Analyst should refer to the SOP of instrument before operation and update the instrument operation logs immediately after use. | |
| 5.4.19 | After the analysis, analyst should hand over the Analytical Work Report to Supervisor/Reviewer analyst for data checking. | |
| 5.4.20 | If Supervisor/Reviewer observed any discrepancy with analysis or analytical data, he / she should consult to Head of the Department for investigation. | |
| 5.4.21 | If all the relevant data on Analytical Work Report complies as per pharmacopoeia or IHS requirement or both, Supervisor/Analyst should prepare “Certificate Of Analysis” as per SOP “Preparation of Certificate Of Analysis”. | |
| 5.4.22 | Full report shall contain AWR, Manufacturer COA, Sampling Inspection Report, GRN copy and COA prepared | |
| 5.4.23 | Quality Control Head shall approve the COA and release the consignment.. | |
| 5.4.24 | After approval of COA, analyst should prepare “APPROVED” labels (green colour) as per Annexure No. 06 with approved by signature on it and affix on all containers in such a way that the under test word on the label should be covered but the details on the under test label should be seen. | |
| 5.4.25 | Assign Retest Date on the approved label as per SOP “Retesting of Raw Materials and Packing Materials”. | |
| 5.4.26 | Photocopy of the approved COA shall be provided to the Warehouse Department if required. | |
| 5.4.27 | Leftover samples should be destroyed as per SOP “Destruction of Laboratory waste”. | |
| 5.4.28 | During analysis if analyst observes the results out of specification or out of limits, he / she should report to the Supervisor or Head of the Department. | |
| 5.4.29 | Supervisor shall initiate investigation as per SOP “Out of Specification” by filling OOS form. | |
| 5.4.30 | After completion of investigation, categorise the observation as analyst error, reagent error, instrument error or material defect. | |
| 5.4.31 | If error observed after investigation due to analyst error, sampling error or reagent/instrument error is confirmed and no defect in the material then the consignment or lot can be released after preparing COA and affixing approved labels on the consignment. | |
| 5.4.32 | If material has minor defect that cannot affect the product quality and not covered in any pharmacopoeia or specification such as dimension of cartons, width of foil is slightly extra; weight of container, Grammage, shade variation then material can be used by filling deviation and approval of Quality Assurance Department and alert notice shall be issued to Supplier or Manufacturer. | |
| 5.4.33 | If material has major defect that can affect the product quality or out of respective Pharmacopoeial requirement for example printed matter of cartons or foils, dimension of foil is less, then material should be considered as Major defect and is rejected. | |
| 5.4.34 | After detail investigation prepare a COA for rejected material with a remark as “Material does not complies with the prescribed standards’’ and affix the label on the material as “REJECTED” (Red colour) with rejected by signature and the reason for rejection as per Annexure No. 07. | |
| 5.4.35 | Photocopy of Rejected COA shall be provided to warehouse. Photocopy is not necessary if software (ERP) is used for material inventory or control. | |
| 5.4.36 | Reference samples of rejected Packing Materials shall be destroyed as per SOP “Destruction of Laboratory waste”. | |
| 5.4.37 | Rejected Packing Material consignment shall be send back to the manufacturer/supplier for further disposal. |
- Definitions /Abbreviations:
- Definitions :
- Sampling: Sampling is a process of collecting a small portion of material from a bulk of material received in the form of consignment or batch having one or more containers/rolls/boxes. The sample collected should represent the whole consignment or batch and should be sufficient to carry out all the testing including reference sample.
- Consignment: The quantity of a bulk material made by one manufacturer or supplied by an agent at one time in response to a particular request or order. A consignment may comprise of one or more containers/rolls/boxes.
- Primary Packing Materials: Materials which comes in direct contact with the drug product. Eg. PVC, Foils.
- Secondary Packing Materials: Materials which comes in direct contact with primary packing materials. Eg. Cartons, leaflets.
- Tertiary Packing Materials: Materials which comes in direct contact with secondary packing materials. Eg. Corrugated boxes.
- Critical defects: A defect that can compromise product safety, purity or identity that may be harmful to the consumer.
- Major defects: A defect that jeopardizes the integrity or function of the package.
- Minor defects: A defect that does not affect product safety, purity or identity or package integrity of function.
- Abbreviations :
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| √n+1 | Under route of n = numbers of containers, bags, drums |
| COA | Certificate of Analysis |
| GRN | Goods Received Note |
| A. R. No | Analytical Reference Number |
| IMS | Inventory Material system |
| IHS | Inhouse Specification |
| OOS | Out Of Specification |
| ERP | Enterprise Resource Procedures |
| PVC | Poly Vinyl Chloride |
| PVDC | Poly Vinyl Dichloride |
| HDPE | High Density Poly Ethylene |
*Note – Ready to use SOP available in “DOWNLOAD” Section.