WAR-090 Sampling Inspection and Release of Packaging Materials

1.0 DOCUMENT OWNER

Warehouse / Quality Manager

2.0 PURPOSE

This procedure explains how to sample, inspect and release packaging materials (except roll feed labels) into the Packaging Store Area. This procedure is GMP critical.

3.0 SCOPE

The scope of this SOP is packaging materials used during the manufacture of products at the GMP facility.

These include, but are not limited to:

Materials used to package the various dosage forms (e.g. tablets, capsules, liquids and pastes) into saleable units (e.g. cartons, labels, bottles, blister film, foil, syringes, containers and stickers).

They also include materials used to package saleable units during transportation or shipment of orders (e.g. shippers, shrink film or shipper labels).

4.0 RESPONSIBILITY

4.1 All deliveries of incoming packaging materials at GMP site must undergo thorough inspection and proper sampling in the Inspection / Sampling Laboratory before they can be released for use.

4.2 Primary packaging materials that come into contact with product are sampled in the Sampling Booth, if sampling is required.

4.3 Each batch or lot of packaging materials from a supplier is regarded as a unique delivery and identified by a unique site Lot Number.

4.4 Components / containers that are damaged or found contaminated during inspection must be referred to Quality Assurance immediately. Appropriate measures are taken to sub-lot the unacceptable portion and separate lot disposition is performed.

4.5 All printed packaging materials are sampled on priority and then placed in the secure packaging store area for printed packaging materials.

4.6 Before carrying out any sampling or inspection of packaging materials, the required Packaging Material Specification (PMS) must be printed. Refer to TEM-150 Packaging Material Specification and Test Report. (APPENDIX E).

4.7 Only the current version of PMS is to be used for carrying out inspection of packaging materials.

4.8 Only trained personnel carry out sampling and inspection of packaging materials. They are called QA Sampling Inspectors. Quality Assurance personnel guide the QA Sampling Inspectors whenever their assistance is required.

4.9 Records relating to sampling and inspection, e.g. filling out the PMS sheets and vendor history have to be updated immediately after sampling and inspection of any lot is carried out.  All ERP System entries are updated before the next lot of any material is processed.

4.10 All queries relating to artwork, PMS or relating to deviations of a sample from the PMS or artwork are immediately referred to Quality Assurance and the Warehouse Manager for speedy resolution and corrective actions to occur.

4.11 Only one lot of one item is sampled and inspected at any time by the QA Sampling Inspector. This is applicable to all sampling in the Inspection / Sampling Laboratory and in the Sampling Booth.

4.12 Additionally, whilst sampling is performed in the Sampling Booth, the applicable SOP’s listed in the reference section are followed with respect to cleaning / clearance and logbook entries.

4.13 Sampling of packaging materials is performed in accordance with General Inspection Level (II) sampling plans (APPENDIX C) for normal, tightened and reduced sampling based on AQL (Acceptable Quality Limit) level (ISO 2859). (APPENDIX B)

4.14 All deviations from this procedure should be captured as per SOP QMS-035 Pharmaceutical Deviation Report System.

4.15 If significant quality defects are occurring, Quality may suspend the use of a supplier for a given item until such time that the supplier rectifies the quality issues.

4.16 Reduced testing on subsequent deliveries of packaging materials from a single manufacturer’s lot are eligible for reduced testing. Reduced test regime is documented in Packaging Material Specification.

4.17 Samples of packaging materials provided by suppliers may be used in place of site’s own samples, where the use of such samples is documented as part of the supplier qualification / certification program.

5.0 PROCEDURE

5.1 Clear the workbench of all items. Choose a delivery of a given item, based on the priorities of the packaging shop floor or as advised by the Warehouse Manager.

5.2 Commence with a careful scrutiny of Form 850 – Inspection of Goods on Delivery (APPENDIX D), supplied by the Receiving Warehouse Operator. Ensure that all the fields have been populated and signed off in accordance with SOP WAR 150 – Booking Incoming Goods. Ensure that the Purchase Order is attached to this document.

5.3 Print the required PMS from Packaging Material Specifications Library.

5.4 Review the history chart for the supplier of the packaging item in the Inspection / Sampling Laboratory.

5.5 On the printed pages of the PMS, enter details of Site Item Number, Purchase Order Number (Order No. Field), Site Lot Number (Delivery No. Field), Date Received and the Quantity of the lot being inspected (Quantity supplied field).

5.6 Check again to ensure that the supplier of the packaging material delivery is the approved supplier as specified in the PMS before commencing sampling, complete Manufacturer and Supplier fields at the time.

5.7 Locate the lot that has to be sampled in the Receiving Warehouse. Ensure that the Lot Number on the ERP System ID label on the containers matches the details on Form 855 – Inspection of Goods on Delivery. Refer to WAR-095 – Status Labels while working on this process.

5.8 Check C of A to see if the manufacturer’s lot number has been received previously or whether it is the first delivery of the batch.

5.9 Check that the physical quantities of the lot match the quantities receipted and recorded by the Receiving Warehouse Operators on Form 850 Inspection of Goods on Delivery and on ERP System.

5.10 If there are quantity discrepancies, first review the receipted Item / Lot / Quantity with the Receiving Warehouse Operators. If the quantities cannot be reconciled with the Purchase Order and other delivery documents, then contact the Warehouse Manager. Ensure that the ERP System records match physical quantities for the lot before proceeding with sampling and inspection.

5.11 Determine the Sampling Plan

There are three (3) possible packaging material inspection plans available to sample a lot of packaging materials:

Refer to APPENDIX A, B and C respectively for guidance on Switching the sampling Plan, AQL Limits and Sampling plans.

– Packaging Materials Single Sampling Plan – Reduced

– Packaging Materials Single Sampling Plan – Normal

– Packaging Materials Single Sampling Plan – Tightened

Follow the rules below to determine the required level of inspection:

5.11.1 For a new supplier of packaging materials, use tightened inspection.

5.11.2 For an existing approved supplier of packaging materials, use either normal inspection or reduced inspection.

5.11.3 To determine the appropriate level of inspection for a particular packaging material delivery, review the “Future Decision” column of the history chart for the previous delivery of this class of component from the supplier. The QA Sampling Inspector would have recorded this along with defect levels when performing the previous inspection.

Refer to APPENDIX A, Switching Sampling Inspection Levels, for details of the switching procedure between normal, reduced and tightened inspections.

5.12 Determining the Sampling Requirements Based on Sampling Plan (APPENDIX C) and Number of Containers in the Delivered Lot and if Manufacturer’s Samples Are Acceptable.  

After determining which sampling plan is to be used, check the particular sampling plan table to determine how many containers (cartons / shippers) need to be opened for sampling based on the number of containers in the delivery.

Use the same sampling plan to determine how many samples are to be drawn from the given lot.

Where the supplier is certified, samples provided by the supplier can be used for inspection and checking. The list of certified suppliers is found with Quality Assurance “Qualified Supplier and Sampling List”.

QA Sampling Inspectors use the appropriate sampling plan to draw sufficient samples from the supplier-provided samples to carry out inspection. Care is taken to ensure that the sampling done is truly representative of the entire delivery.

In the case of subsequent deliveries of a large packaging manufacturer’s lot or print run, the sampling from the first delivery and subsequent deliveries is carried out in accordance with QA instructions and is based on supplier certification.

Sampling requirement for the first delivery of a given manufacturer’s lot is calculated using the total print run or lot quantity rather than the quantity in the first delivery. This is done to approve the full manufacturer’s lot for use. Subsequent deliveries of the same manufacturer’s lot are eligible for limited acceptance testing per PMS.

5.13 Sampling procedure in the Sampling Booth

Always conduct the sampling of packaging materials in a manner that avoids any contamination.  Process only one lot of one item at any time.

Sample all primary packaging materials that come into contact with product (for example, foils, PVC, PVDC rolls, bottles, caps) in the sampling booth.

The sampling booth should be cleaned between the sampling of individual materials as described in SOP WAR-105 Cleaning the Sampling Booth and Implements in the Raw Material Quarantine Store, SOP WAR-085 Sampling and Inspection of Raw and Bulk Materials and SOP WAR-100 Sampling of Raw Materials in Sampling Booth.

Room clearance and display of room status should be carried out in accordance with SOP

WAR-105 Cleaning the Sampling Booth and Implements in the Raw Material Quarantine Store and logbook entries should be maintained in accordance with SOP WAR-100 Sampling of Raw Materials in Sampling Booth and SOP MAN-015 Factory Cleaning Procedure.

5.14 Obtain the Materials to be Sampled

Locate the delivery of packaging materials in the Receiving Dock.

Ensure that the delivery details (i.e. item number, description and delivery / lot number) on the Purchase Order, PMS and delivery labels and Form 850 Inspection of Goods on Delivery all match.

Open a ERP System session with your individual sign-on and password; generate one “Sampled” label for each container in the lot that will be sampled.

Randomly select the required number of containers (determined in Step 5.12) to be opened for sampling by visually inspecting the delivery pallet and choosing a container from the top, bottom and middle of the pallet.

Randomly select the required number of sample materials from each of the containers to be opened for sampling to draw the total number of samples as per the requirement of the specific sampling plan being followed.

Ensure that all sample materials taken from one container is kept separate from those that were taken from other containers before inspection.

Reseal all opened sample containers with adhesive tape. Affix one “Sampled” label per container sampled.

Complete the Sampling transaction in the ERP System.

This reduces the inventory in ERP System by the quantity of sample drawn for the given item / lot.

Note: In the case of supplier-provided samples, the sampling quantities are accounted for in ERP System, either at the outset whilst inventory is booked into ERP System or during the sampling process on a case-by-case basis and is determined by the commercial agreements between GMP site and the supplier as to how samples are accounted / paid for. In all circumstances, the ERP System inventory must reflect physical inventory once samples are removed from any given delivery.

5.15 Test Samples

Once the samples have been collected, take them into the Inspection and Sampling Laboratory to check the samples against specifications in the PMS and in accordance with the test procedure for that material.

In the case of printed packaging material, check the sample material against the controlled copy of the artwork.

Perform each test as specified in the PMS (TEM-150 Packaging Material Specification and Test Report). (APPENDIX E). Ensure that you record the results directly onto the PMS at the appropriate locations for each test. Where the method specified is “C of A”, record “Complies” in results column if it complies with the test method.

For example: consider a case where 125 samples of printed cartons have been sampled for inspection and 2 defects are noticed (e.g. print smudge). Record the number of samples with defect on PMS and whether it is Critical, Major or Minor and record comments.

Wherever the PMS requires you to check and record length, width, depth or height, refer to the Test Procedure on the PMS and record dimensions accordingly.

The PMS should be signed and reviewed by a second person for correctness before an assessment can be made on suitability for release.

For detailed information about the individual test procedures, refer to the Test Procedure Methods File at QA Laboratory directory location:

5.16 Determine if the Sample Complies and if the Lot Can Be Released or Not

Once all the test procedures on the sample materials have been completed, determine whether to release, reject or quarantine the delivery of packaging materials.

SOP WAR-110 Classification of Defects for Incoming Packaging Components is to be followed if a defect is found during testing.

The lot can be released if the total number of recorded major and minor defects is less than or equal to the pre-determined acceptance number specified in the sampling plan.

The lot should be rejected when there are greater than allowed critical defects or if the total number of recorded major or minor defects is greater than the allowed rejection numbers in the sampling plan.

Note: If you find any discrepancies in the PMS while conducting a particular test procedure leave the delivery of packaging materials in quarantine and contact Quality Assurance immediately.

If the information on the PMS needs to be changed or updated, raise a Change Request in accordance with SOP QMS-015 Quality Documentation Management and Change Control.

5.17 Finalise Documentation

5.17.1 Complete PMS Details

Add the following details to the front page of the PMS.

– Number of allowed and found Critical Defects.

– Number of allowed and found Major Defects.

– Number of allowed and found Minor Detects.

– Delivery tested by. 5.16.1.6 Delivery tested date.

– Delivery Released / Rejected (circle the appropriate entry).

– Retest Date.

– Comments (if applicable).

5.17.2 Sign and Date the PMS

Attach a sample of the packaging material (except items like bottles) to the PMS as a retention sample.  For large sample items like bottles, label the sample with the delivery number details and store in a locked cupboard.

If the lot of packaging materials failed inspection, apply the “REJECTED” stamp Form 850 Inspection of Goods on Delivery.

Destroy all other samples drawn for this lot.

5.17.3 Add the Following Details to the History Chart and Inform QA Immediately if Quality Issues are Noticed that Warrant a Change in Sampling Plan.

Major defects found: (MAJOR DEFECTS ACT).

Minor defects found: (MINOR DEFECTS ACT).

Pass: (Yes / No).

Future Decision: (i.e. reduced, normal or tightened).

Signed by:

Comments:

Note: For a first-time delivery of a packaging material, complete “Quality Control Master Label Form”.  Attach a sample of the packaging material to the form. Ensure that the form is signed. Forward this document with the control copy of artwork to Quality Assurance. 

5.18 Change Lot Status in ERP System. Refer SOP Lot Disposition how to change the status of a lot.

The QA Sampling Inspectors are required to move the lot into appropriate areas physically and in ERP System to reflect the lot status after disposition in ERP. They will seek the assistance of the Warehouse Manager to achieve the movement in ERP.

Complete the details and disposition in the Packaging Component Release and Quality Audit logbook Every 10th delivery is placed into the QA in-tray for checking by Quality Assurance.

5.19 File Documents:  PMS, History Chart and Receiving Report.

5.19.1 Ensure a copy of the Purchase Order is attached to the filled out sheets of PMS.

5.19.2 Return these documents to the product file.

5.19.3 Return the History Chart to the Supplier file.

5.19.4 Transfer released material to the packaging warehouse in ERP System and physically to locations in the packaging store racks using RF scanners or the ERP System console.

5.19.5 Immediately transfer Rejected materials to the reject cage physically and in ERP System.

5.19.6 Immediately transfer Quarantine-Hold material to the Q-Hold cage physically and in ERP System.

APPENDIX A: Switching Sampling Inspection Levels

APPENDIX B: Acceptable Quality Limit (AQL)

APPENDIX C: SAMPLING PLAN: (ISO 2859)

APPENDIX D: Inspection of Goods on Delivery Form

APPENDIX E: Packaging Material Specification and Test Report Template