Department | Quality Management | Document no | QMS-190 | ||
Title: Inspection, Sampling and Disposition of Incoming Goods | |||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
1. PURPOSE
This procedure defines the inspection, sampling and disposition of incoming (purchased) goods.
2. SCOPE
This procedure is applicable to all inventory goods and consumable items at any GMP site including contract manufacturing processes.
3. RESPONSIBILITIES
3.1. QA Personnel
– Responsible for inspection, organization of sampling and disposition of all inventory goods and critical consumables as per this procedure.
3.2. Warehouse Personnel
– Responsible for the receipt of all items delivered to Virbac Penrith and Crookwell facilities.
3.3. Logistics / Purchasing Personnel
– Responsible for the ordering of items from the appropriate approved supplier/manufacturer.
3.4. QC Personnel
– Responsible for the testing of raw materials as per the relevant specification.
4. SAFETY AND PROCESS SPECIFIC INFORMATION
All safety requirements for relevant areas at the facility must be followed at all times.
5. DEFINITIONS
5.1. Inventory goods – Goods that are inventory controlled by the ERP system.
5.2. Critical Consumables – goods that are directly related to the manufacture of product but not present in the finished product and any items that have the potential for product contact or may directly influence the product quality.
5.3. Non-Critical Consumables – Goods that are not directly related to the manufacture of product.
5.4. Expiry date – date the material is at the end of its shelf life and a retest and/or re-evaluation of material is not permitted.
5.5. Retest date – date by which material requires a retest and/or re-evaluation for continued use.
5.6. QIS – Quarantine Inspection Sheet
5.7. PPE – Personnel Protective Equipment
5.8. C of A – Certificate of Analysis
5.9. C of C – Certificate of Compliance
6. SAFETY
6.1. The appropriate PPE must be worn at all times during sampling procedures. Before sampling of any item is commenced, refer to the appropriate MSDS.
6.2. To prevent cross contamination and ensure sampling of raw materials is carried out safely, personnel will wear at a minimum:
– Laboratory coat
– Disposable dust mask / respirator mask (when necessary)
– Powder free gloves
– Hair net
– Shoe covers
– Safety glasses/goggles
(Refer WAR-045 Sampling of Raw Materials)
7. PROCEDURE
7.1. Receipt of Goods
Goods are delivered to the Warehouse and receipted as per WAR-005 Receipt of Incoming Goods.
7.1.1. Lot Controlled Items
For all lot-controlled items, use the checklist as follows:
– Form 945: QA Inspection and Disposition of Raw Materials Checklist
– Form 950: QA Inspection and Disposition for Incoming Goods Checklist.
These documents contain the Quarantine Inspection Sheet (QIS) section on page one which is completed by the Receiving Store and forwarded to QA personnel.
The remaining pages contain the QA Inspection and Disposition Checklist to be completed by QA personnel.
7.2. Classification of Incoming Goods
7.2.1. Inventory Goods – QA disposition required.
– Raw Materials.
– Registered Packaging (e.g. labels, leaflets, cartons).
– Non-registered Packaging (e.g. shippers).
– Registered Components (e.g. primary containers).
– Non-registered Components (e.g. cardboard inserts, draw off tubes).
7.2.2. Critical Consumables – QA disposition required.
– Filters used in Production areas.
– Chemicals used in Maintenance areas.
– Environmental Monitoring Media.
– Cleaning and Sanitizing Agents used in GMP areas.
7.2.3. Non-Critical Consumables – QA disposition not required.
– QC and ASD chemicals.
7.3. Inspection of Goods
7.3.1. Upon receipt of the QIS from the Warehouse Receival store, or a requirement for re-evaluation of material, QA Personnel will select the appropriate specification file and relevant checklist.
– Form 945 – QA Inspection and Disposition of Raw Materials Checklist
– Form 950 – QA Inspection and Disposition of Incoming Goods Checklist
– Form 955 – QA Inspection and Disposition of Raw Materials Pre-Purchase Samples Checklist.
7.3.2. The relevant information on the QIS, Specification and Checklist shall then be checked by QA Personnel:
– Name of material.
– Quantity received.
– Supplier name.
– Manufacturer’s name.
– Test sample requirements.
– Manufacturer’s code/batch number/lot number.
7.3.3. The Purchasing Department shall be notified if required documentation has not been received with the delivery (e.g. C of A; Sterility Certification).
7.3.4. For raw material deliveries received directly into the warehouse, trained personnel will be responsible for the visual inspection of goods. Once the material inspection is complete the checklist is returned to QA. Disposition of the material will be finalised in ERP system and the required number of status labels printed and sent to warehouse for application to the goods.
7.3.5. All goods shall be inspected and dispositioned within cycle times.
7.3.6. Raw Materials
Using Checklist Form 945 – QA Inspection and Disposition of Raw Materials Checklist, QA personnel shall confirm and document the following where applicable:
Presence of all relevant documentation (as appropriate):
– Certificate of Analysis.
– Certificate of Conformance.
– Certificate of Sterility/Irradiation.
– Any Import Permit (if applicable).
– Supplier and Manufacturer.
Visual inspection of containers:
– ID of product checked and confirmed against QIS.
– Containers clean, undamaged, sealed.
– Sterility/irradiation labels applied to each container (as appropriate).
– Each container is labeled with supplier/manufacturer ID / Batch No.
– Quarantine restricted raw materials (e.g. peptones) have an ‘Bio Security Controlled’ label applied by Warehouse personnel to every container (as appropriate).
– All raw materials have an “under inspection” label applied by Warehouse personnel to every container or every pallet.
Sampling:
– Raw materials require testing as per the relevant specification, before disposition may be determined.
– Raw materials shall be sampled by QA personnel for testing, using the relevant Material Specification and WAR-045 Sampling of Raw Materials.
– Retention samples from raw materials shall be taken by QA personnel, as per QMS-195 Retention Sample Management.
– QA personnel shall complete the top section of Form-960 Quality Control Test Request and Results and forward together with the test sample(s).
7.3.7. Packaging / Labels / Components
Using Checklist Form 950, QA Inspection and Disposition of Incoming Goods Checklist, QA personnel shall confirm and document the following where applicable:
Presence of all relevant documentation (as appropriate):
– Certificate of Analysis
– Certificate of Conformance
– Certificate of Sterility/Irradiation
– Certificate of Fluorination
– Supplier and Manufacturer
Visual inspection:
– ID of product checked and confirmed against QIS
– Item is clean and undamaged
– Sterility/irradiation labels applied to each carton (as appropriate)
– Fluorination labels applied to each carton (as appropriate)
– Each pallet/carton labeled with supplier/manufacturer ID and Batch Number
– Each individual carton and/or pallet has an “under inspection” label applied by Warehouse personnel.
Sampling:
– Inspection samples shall be taken by trained Warehouse staff or QA personnel on receipt as per WAR-085 Sampling and Inspection of Raw and Bulk Materials and forwarded to QA with the QIS.
– Retention samples from all deliveries shall be taken by trained Warehouse staff or QA personnel, as per QMS-195 Retention Sample Management.
7.3.8. Critical Consumables: (e.g. filters; sterile products).
Using Checklist Form-950, QA Inspection and Disposition of Incoming Goods Checklist, QA personnel shall confirm and document the following where applicable:
Presence of all relevant documentation:
– Certificate of Analysis
– Certificate of Conformance
– Certificate of Sterility/Irradiation
– Supplier and Manufacturer
Visual inspection:
– ID of product checked and confirmed against QIS
– Item is clean and undamaged
– Sterility/irradiation labels applied to each carton (as appropriate)
– Fluorination labels applied to each carton (as appropriate)
– Each pallet/carton labeled with supplier/manufacturer ID and Batch Number
– Each individual carton and/or pallet has an “under inspection” label applied by Warehouse personnel.
7.3.9. Advanced Samples (Pre-batch – New Supplier/Manufacturer).
Advanced samples of Raw Materials received by Warehouse Receival store are forwarded to QA Personnel with the QIS.
Using checklist Form-955, QA Inspection and Disposition of Raw Materials Pre Purchase Samples Checklist, QA personnel shall confirm and document the following where applicable:
Presence of all relevant documentation (as appropriate):
– Confirm sample type (pre-batch test sample; change control sample; other)
– Certificate of Analysis
– Certificate of Conformance
– Certificate of Sterility/Irradiation
– AQIS Import Permit
– Supplier and Manufacturer
Visual inspection:
– ID of product checked and confirmed against QIS
– Containers clean, undamaged, sealed
– Each container identified with supplier/manufacturer ID / Batch No.
– Sterility/irradiation labels applied to each carton
Testing:
– QA personnel shall complete Form-960 Quality Control Test Request and Results and forward together with the test sample, QIS and Certificate of Analysis to QC.
Once testing is completed and disposition determined, the original documentation shall be filed by QA and Purchasing informed by email of the results. In the case of evaluation of a new supplier, another copy of the test results, QIS and checklist, shall be attached to the relevant Change Control documentation.
8. Disposition of Incoming Goods
8.1. Once a delivery has been inspected, tested, retention samples taken and all documentation reviewed, the disposition of the delivery shall be determined.
8.2. Determine the disposition of the batch as follows:
8.2.1. Where the defined criteria of the delivery comply with requirements, the batch is approved, and the disposition is RELEASE.
8.2.1. Where the delivery does not comply with requirements, proceed as per QMS-135 Quality Risk Management Techniques (Risk Ranking and Filtering – Method 1).
– If an OOS result (QC test failure) is identified during the inspection and testing process, QC will raise a deviation in the deviation system and the risk assessment will be conducted as part of the deviation investigation process.
– If a non compliance is identified that is not as a result of a QC test failure then a deviation is not required and the risk assessment will be conducted by QA personnel using the Risk Ranking and Filtering – Method 1 template.
– When a risk assessment results in a disposition decision of ‘RESTRICTED RELEASE’, proceed as per instructions in WAR-095 Status Labels and QMS-185 Batch Review and Release for Supply – Non Sterile.
8.2.3. Where the delivery does not comply with requirements and the disposition decision is reject, proceed as per QMS-200 Rejection of Materials.
8.3. QA personnel shall complete relevant sections on QIS and Inspection and Disposition Checklist.
8.4. The appropriate disposition labels, containing the “Unique Lot No” and date, shall be attached according to WAR-095 Status Labels.
8.5. All “Under Inspection” labels attached to the items must be covered with a disposition label.
Note: When approved:
– Cartons containing bottles/containers for use in Production must have an “Approved” disposition label applied to every carton on the pallet.
– Leaflets must have an “Approved” disposition label applied to every pack within the carton as well as the outside of the carton.
– Labels rolls must have an approved label placed on the bag and an additional label applied to the label core.
– Raw materials must have an approved label attached to each individual bag, container or drum.
8.6. The white copy of the completed QIS is retained for QA records. All associated paperwork shall be filed in the appropriate item folder.
8.7. A copy of the completed QIS shall be returned to the warehouse.
8.8. The disposition of the delivery shall be recorded by QA personnel in the Visual Management tracking spreadsheet.
9. Re-evaluation of incoming goods for continued use:
9.1. Raw Materials:
Using Checklist Form 945, QA Inspection and Disposition of Raw Materials Checklist, QA personnel shall confirm and document the following where applicable:
Visual inspection of containers:
– Containers clean, undamaged, sealed
– Each container labeled with supplier/manufacturer ID / Batch No.
– Quarantine restricted raw materials (e.g. peptones) have an ‘Bio-Security Controlled’ label applied by Warehouse personnel to every container.
Sampling:
– Raw materials require re-evaluation testing as per the relevant specification before disposition may be determined.
– Raw materials shall be sampled by QA personnel for testing, using the relevant Material Specification and WAR-045 Sampling of Raw Materials.
– QA personnel shall complete the top section of Form-960 Quality Control Test Request and Results and forward together with the test sample(s).
9.2. Packaging / Labels / Components
Using Checklist Form-950, QA Inspection and Disposition of Incoming Goods Checklist, QA personnel shall confirm and document the following where applicable:
Visual inspection:
– Item is clean and undamaged
– Each pallet/carton labeled with supplier/manufacturer ID and Batch Number
Sampling / Re-evaluation Testing:
– Re-evaluation inspection samples shall be taken by QA or warehouse personnel as per WAR-085 Sampling and Inspection of Raw and Bulk Materials and the relevant specification.
– Items shall be re-evaluated against original reference sample and specifications (where applicable) for the following:
1. General appearance
2. Colour ( bottles, labels, cartons, leaflets etc.)
3. Adhesive properties (labels, cartons, shippers etc.)
4. Operating mechanism (applicators, guns etc.; these may need to be returned to supplier for re-lubricating if a problem with leaking is identified during retesting).
10. Disposition of re-evaluated Incoming Goods
Once the re-evaluated samples have been inspected, tested, retention samples taken and all documentation reviewed, the disposition of the batch shall be determined.
10.1. Where the defined criteria of the samples comply with requirements, the batch is approved and the disposition is RELEASE
10.2. Where the samples do not comply with requirements/specifications, proceed as per QMS-135 Quality Risk Management Techniques (Risk Ranking and Filtering – Method 1).
10.2.1. If an OOS result (QC test failure) is identified during the inspection and testing process, QC will raise a deviation in the deviation system and the risk assessment will be conducted as part of the deviation investigation process.
10.2.2. If a non compliance is identified that is not as a result of a QC test failure then a deviation is not required and the risk assessment will be conducted by QA personnel using the Risk Ranking and Filtering – Method 1 template
10.3. Where the delivery does not comply with requirements and the disposition decision is reject, proceed as per QMS-200 Rejection of Materials.
10.4. QA personnel shall complete the relevant Inspection and Disposition Checklist.
10.5. The appropriate disposition labels, containing the “Item code”, the “Unique Lot Number” or “unique batch number” and new expiry date, shall be attached to the individual containers of the goods.
10.6. The disposition of the batch shall be recorded by QA personnel in the retest pending tracking spreadsheet.