SOP for Packaging Material Testing | Sampling plan for packaging materials | AQL for packaging material |
- SOP for Packaging Material covers below points :
- Receiving procedure of Goods Receipt Note (GRN)
- Sampling plan for packaging materials / Planning for Sampling of Packaging Materials
- AQL for packaging material / Acceptable Quality Level (AQL) inspection
- Testing of Packaging Materials
- Approval procedure of Packaging Material
- Rejection procedure of Packaging Material
- Sampling Plan as per Acceptance Quality Level (AQL) for Packaging Materials format
- Acceptance Quality Level (AQL) of Packaging Material format
- Acceptance Quality Level Observation of Packaging Material format
1.0 OBJECTIVE :
- To provide procedure for sampling, testing and approval/ rejection of packaging material based on statistical sampling Plan.
2.0 SCOPE :
- This procedure is applicable to sampling of all primary, secondary and tertiary packaging material and testing and approval/ rejection of packaging materials with respect to the laid down standards.
3.0 RESPONSIBILITY :
- Quality Control Chemist and above
4.0 ACCOUNTABILITY:
- Quality Control Head
5.0 PROCEDURE :
5.1 Definitions
- Batch Number (or Lot Number): A distinctive combination of numbers and/or letters, which specifically identify a batch or lot and permit its history to be traced.
- GRN No.: A distinctive sequential number allotted by packaging material warehouse for receipt of each consignment of a material batch wise and receipt wise.
- Sampling: The process of abstraction of a portion of material from a larger quantity.
- Primary packaging material: The packaging material which is in direct contact with product. e.g. Aluminium foils, PVC and PVdC coated PVC film, HDPE container, Glass bottle, Poly-laminated paper etc.
- Secondary Packaging material: The Packaging material which is not in direct contact with product. e.g. Cartons (inner/ Outer), leaflet, Catch cover etc.
- Tertiary Packaging material: The Packaging material which is not in direct contact with product, used to protect manufactured goods. e.g. Shrink, Corrugated box, BOPP tape, Strapping roll etc.
5.2 Receiving of Goods Receipt Note (GRN):
- Warehouse department receives the packaging material & checks for the condition of shipment and actual quantity of packaging material received as per purchase order.
- Warehouse department creates Goods Receipt Note (GRN) in ERP system and sends to Quality Control Department along with manufacturer’s COA, wherever applicable. In case COA is not received, inform to Head.
- After receiving GRN, verify that the vendor is qualified against approved vendor list. If not, refer the matter to Head.
- Enter the details of materials such as Date, GRN No., Name of material, Quantity received, Quantity sampled, Name of supplier in Packaging Materials Register.
- Assign Analytical Report number (AR No.) as per SOP of Assigning Analytical Report Number, and mention AR No. in Packaging Materials Register.
5.3 Planning for Sampling of Packaging Materials:
- Sampling Personnel
- Personnel, who have been appropriately trained for the sampling purpose, shall carry out sampling.
- Personnel should be observant, meticulous and should understand the nature of material being handled.
- Pre-checks before sampling and precaution
- Before sampling, ensure that the packages in which materials are received are properly packed.
- Before sampling, identify that sample containers are properly labeled for the name of the material and other details of the consignment.
- Verify the exterior of the container, clean it if required.
- Check for number of containers received against the GRN.
- Check and compare the details of packaging material on manufacturer’s COA, GRN and label affixed on the containers.
- In case outer box is damaged, check the inner box and if it is in good condition, perform sampling.
- If the sampling is performed from outer damaged container, instruct to ware house person to replace the material with in-house satisfactory container and pack the container in a proper way to avoid the further damage to the material.
- In case outer as well as inner box is damaged, affix “ON HOLD” label and bring it to the notice of QC Head and QA Head with complete documentation of incident.
- The sampling of primary packaging materials such as Aluminium foils, PVC and PVdC coated PVC film, HDPE container, Glass bottle, Poly-laminated paper will be carried out in sampling booth under reverse laminar air flow (RLAF).
- Sampling
- Carry out sampling for each GRN.
- Check the general conditions of the containers/ boxes/ pack in the consignment.
- Confirm the details like Name of material, Batch No./ Lot No.(if applicable), Name of supplier and GRN No. These should be matched with GRN.
- Ensure that “QUARANTINE” Label is affixed by Warehouse department. For all packaging materials, minimum 25% of the total number of packs shall have “QUARANTINE” label.
- Clean the exterior of the container.
- Sampling of Packaging material should be performed within a week after creation of GRN.
- Collect the samples randomly from (n+1) packs/containers where ‘n’ stands for total number of packs received.
- Total 10 meters of printed foils shall be collected from all selected rolls after discarding first 0.5 meter foils from the each roll.
- Sampling and inspection for Acceptance Quality Level (AQL) Inspection shall be performed as per point No. 5.4.
- Collect the samples (except corrugated box) in a clean dry polythene bags and label them properly.
- After sampling, affix the label “SAMPLED” with signature and date of sampling on those containers from which the sample are taken.
- Enter the following details and affix a yellow coloured “UNDER TEST” label on the consignment with at least the following details;
- Material name
- Quantity received
- G.R.N. number with Date
- Manufacturer’s Name
- Supplier’s Name, if different
- Name of the person who sampled along with date
- After sampling is over, ensure that the containers / packets / boxes are properly closed.
- In case of any variance in supply due to unavoidable circumstances, purchase department should inform to Q.C. Head or his/her designee in advance or with supply. However, opinion of Q.C. Head will be final for acceptance or rejection of it.
5.4 Acceptable Quality Level (AQL) inspection:
- Sample size for Acceptable Quality Level (AQL) inspection, which is statistical methodology for quality inspection purpose, shall be decided as per the attachment of “Sampling Plan of Acceptance Quality Level for Packaging Materials”, Annex. No. 01.
- Samples for AQL inspection shall be collected throughout the selected number of boxes for sampling according to sample size and number of boxes/ containers. For example, in case of 125 number of samples which shall be collected from 6 containers, then 21 samples from each 5 containers and 20 samples from last 6th container.
- The samples for AQL inspection shall be examined by QC personnel against the attachment of Acceptance Quality Level (Packaging Material), Annex. No. 02.
- In AQL inspection, defects are classified in to three categories;
- Critical Defects
- Major Defects
- Minor Defects
- Observation of AQL inspection shall be reported in format of “Acceptance Quality Level Observation” Annex. No. 03.
- If the number of defects found in the sample is equal to or less than the acceptance number, the lot/consignment shall be considered acceptable.
- If the number of defects is equal to or greater than the rejection number, intimate the same to QC Head for lot/ consignment failing in the acceptance quality level criteria, report the same with initiating the deviation and reinspect the lot/ consignment. For example, during AQL inspection, if lot size is 1300 then according to Annex. No. 01, designated sample size is 125 units, in case of minor defects is found 6 and as per Annex. No. 01, acceptance number is 5 and rejection number is 6. Thus the lot is rejected.
- In case of re-inspection, use the same sampling plan and examine for the defects and if the number of defects is equal to or greater than the rejection number, then batch decision will be based in deviation closure.
- Observation of AQL inspection of re-inspection shall be recorded in in format of “Acceptance Quality Level Observation” Annex. No. 01 with keeping remark by manually on the bottom left corner.
- After completion of AQL Inspection observation, the sample shall be collected for testing from the same samples taken for AQL Inspection as per the table of Sample Quantity for Packaging Material testing as follows;
| Sr. No. | Packaging Materials | Sample Quantity for Packaging Material testing |
| 1 | Aluminum Foil | 10 meters |
| 2 | Poly-laminated paper | 10 meters |
| 3 | PVC and PVdC coated PVC film | 5 meters |
| 4 | Carton (Inner / Outer) | 15 Nos. |
| 5 | Leaflet | 15 Nos. |
| 6 | Catch cover | 15 Nos. |
| 7 | Shrink Bag | 10 Nos. |
| 8 | HDPE container | 05 Nos. |
| 9 | Glass bottle | 05 Nos. |
| 10 | Corrugated box | 01 No. |
| 11 | BOPP Tape | 01 No. |
| 12 | Strapping roll | 05 meters |
| 13 | Silica gel bag | 05 Nos. |
- The remaining samples of AQL Inspection shall be returned to the boxes/containers of the same consignment.
5.5 Testing of Packaging Materials:
- The samples will be inspected for the conformity of consignment with respect to the requirement of laid down standard and specification.
- Dimension of Packaging material shall be measured by calibrated steel foot ruler and vernier calliper in millimeter.
- Grammage of the secondary & tertiary Packaging material shall be determined in gm/m2 by the following formula;
- Grammage = Av. Wt. of sample in gm x 10,000 / Total area (Length x breadth) in cm2
- Determine the average weight by weighing a suitable number of samples on single pan balance.
- Check the physical dimension of 10 samples.
- Printed Matter Layout and colour shade
- Colour of the sample of received printed consignment (Printed Aluminium foils, cartons and leaflet) should be verified against shade card or Coated pantone.
- Printed matter should be in accordance with photocopy of latest approved artwork, as received from Regulatory Section or Loan Licensor in case of Loan License Product.
- Printed Matter Layout other than English and Hindi languages
- Printed Packaging material in other language shall be inspected with the help of positive.
- The sample shall be kept between two films of positive, preferably to match alignment.
- Each word & design of printed matter should be matched with positive.
- Other Parameters will be tested as per specification and standard testing procedure. The samples shall comply with the laid down specification.
- Destroy the left over sample after tests.
- In case of any deviation bring it to the notice of QC Head or his/her designee.
- Acceptable specific limits of colour shades can be decided due to limitation of getting standard shades in printing ink and variation ink, from batch to batch, but printed Packaging material should not differ very much from “Counter Control” of the same standard sample kept in Quality Control Department.
- Slightly under or over cutting of label or cartons may be acceptable at the discretion of QC Head due to limitation in cutting of printed material sheets. However the unit of printed Packaging material in which printed matter is out, much undersize or oversize, cross cutting and cross pasting flap is not acceptable.
5.6 Approval of Packaging Material:
- After completion of testing, analyst shall report to reviewer with filled work sheet.
- Reviewer shall review the complete document and sign with date.
- Analyst shall enter the data in ERP system based on approved filled work sheet.
- Reviewer shall verify the COA in ERP system against the raw data and ensure that the results are correct.
- After verifying COA, reviewer shall click on “Checked by” tab in ERP system.
- The reviewed documents along with analytical raw data shall be submitted to QC Head or his/her designee for approval.
- QC Head or his/her designee shall review the documents and COA in ERP system.
- QC Head or his/her designee shall approve the COA in ERP system by clicking on “Approved by” tab.
- Certificate of Analysis (COA) and Approved label will be taken from ERP system.
- A dully signed green “APPROVED” label with proper details shall be affixed on the container(s) in place of “QUARANTINE” label.
5.7 Rejection of Packaging Material:
- Out of specification (OOS) results or any deviation found from the specification must be brought to the notice of QC Head.
- The Packaging material shall be kept “ON HOLD” immediately.
- Reviewer shall review the analytical data and raise Rejection Note as per Annex. No. 04.
- Rejection note shall be approved by QA department and the same shall be handed over to Warehouse department.
- ERP procedure for rejection is same as approval procedure.
- The material shall be rejected in ERP system by QC Head of his/ her designee by entering required data and clicking on “Approved by” tab.
- Certificate of Analysis (COA) and Approved label will be taken from ERP system.
- A dully signed red “REJECTED” label with proper details shall be affixed on the container(s) in place of “QUARANTINE” label.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| ERP | Enterprise Resource Planning |
| Nos. | Numbers |
| HDPE | High Density Poly Ethylene |
| PVC | Poly vinyl Chloride |
| PVdC | Poly vinylidene Chloride |
| COA | Certificate of Analysis |
| GRN | Goods Receipt Note |
| AQL | Acceptable Quality Level |
7.0 ANNEXURES
| Annex. No. | Title |
| 01 | Sampling Plan of Acceptance Quality Level for Packaging Materials |
| 02 | Acceptance Quality Level (Packaging Material) |
| 03 | Acceptance Quality Level Observation |
| 04 | Rejection Note |
| 05 | Check list for Packaging Material Analysis Completion |
8.0 SOP REFERENCES
- Orange Guideline MHRA – Rules and Guidance for Pharmaceutical Manufacturers and Distributors – 2017 (Quality Control, Annex 8)
- PIC/s –Guide to Good Manufacturing Practice for Medicinal Products – 2018 (ANNEX 8)
- Military standard –MIL-STD-105 E
- American national standard institute (ANSI)
- International standard organization-2859 (ISO-2859)
END OF THE SOP
ANNEXURES :
Annex. No. 01 Sampling Plan of Acceptance Quality Level for Packaging Materials
Annex. No. 02 Acceptance Quality Level (Packaging Material)
Annex. No. 03 Acceptance Quality Level Observation
Annex. No. 04 Rejection Note
Annex. No. 05 Check list for Packaging Material Analysis Completion
