QMS-200 Rejection of Materials

Purpose

The purpose of this standard operating procedure is to describe the process to be followed for the rejection of materials at a GMP sites.

Scope

This procedure is applicable to all inventory items. This includes, but is not limited to, finished and intermediate product, master and working seeds, raw materials, packaging, consumables, in-process production and returned goods.

This procedure does not apply to items rejected as a result of reaching expiry or obsoletion.

Responsibilities

Quality Assurance is responsible for:

 – Ensuring that this procedure is followed for all material rejections.

 – Training of appropriate staff approved to apply status labels.

Logistics Department (Warehouse and Purchasing) is responsible for:

 – Raising a SRN when required.

 – Moving rejected stock to a reject location.

 – Arranging for disposal of rejected goods, or

 – Arranging for the return of rejected purchased goods to the supplier.

 – Ensuring application of ‘Reject’ status labels is only performed by personnel trained by QA.

Production is responsible for:

 – The disposal of rejected in-process (bulk) products.

Definitions

QRN: QA Rejection Number

QARN: QA Rejection Notification

SRN: Stock Rejection Notification

ERP:  Enterprise Resource Planning

General

 1. The process of identifying, evaluating and relocating material to be rejected must be performed without delay. This is particularly important for material that is to be returned to the supplier as a delay may compromise company’s ability to make a claim on the supplier or insurance agent.

1.1. Photographs should be taken of damaged goods if possible.

 2. With the exception of inwards goods, the decision to reject an item will be as a result of one of the following:

2.1 Deviation

2.2 Product Complaint

2.3 Returned Goods assessment 2.4

 3. Once the decision has been made to reject the item, the Rejection of Materials procedure will apply.

Procedure

 1. The QA Associate responsible for the disposition of the material will initiate and ensure completion of the QARN (QA Rejection Notification).

 2. All batch documents, deviations and investigation reports will be completed before rejecting the material.

 3. The details of the material to be rejected will be entered into the Rejected Materials Register, located in the QA office, and the QRN (QA Rejection Number) assigned. 

a. The QRN is a sequential number, in the format ‘XX/YY’, where XX is the next available sequential number and YY is the last 2 digits of the year. E.g. 01 for the first number on the register and 20 for the year, thus giving a number 01/20.

 4. The QARN (QA Rejection Notification) will be completed with the following information and forwarded to the QA Manager for approval:

 a. Item description and number

 b. Lot number

 c. Incident reference and reason for rejection

 d. Quantity of material to be rejected, and whether it is a full or part batch rejection

 e. Purchase order no and supplier/manufacturer (if applicable)

 f. Cost of goods (for bulk and finished product only)

 5. Once rejection of the material is approved, it will be changed to status ‘Stock identified as not possible to rework and having to be disposed of’ in the ERP system.

 6. Part batch rejection:

 a. When only part of the batch is to be rejected, QA will notify warehouse to physically separate the stock before performing ERP transactions and status labeling the material.

 b. The Lot Number of the material will be modified by assigning a ‘A’ suffix (Stock identified as not possible to rework and having to be disposed of) if the material is to be disposed of or an ‘B’ suffix (Stock identified as needing to be returned to a supplier) if the material is to be returned to supplier.

 7. ‘REJECT’ labels will be printed.

 8. One label will be attached to the back of the QARN and one label will be attached to the batch documents.

 9. Rejected material will be labeled by QA or trained and approved warehouse personnel as follows:

 a. Bulk vaccine and pharmaceutical product – reject labels are not physically applied to the blending/holding tank. The supervisor will write “REJECTED” on the tank status board.  A label will be attached to the batch documents and QARN only.

 b. Contained Antigen – reject labels will be applied to each cask.

 c. Filled, unlabeled vaccine – reject labels will be applied to each bin containing vaccine.

 d. Packed pharmaceutical product – reject labels will be applied to each pallet of product.

 e. Packed vaccine – reject labels will be applied to each pallet of product.

 f. Packaging /consumables – reject labels will be applied to all pallets and/or cartons.

 g. Raw materials – reject labels will be applied to each container.

 h. Returned Goods – reject labels will be applied to each container.

 i. Finished or Semi Finished goods at Milperra Warehouse – all pallets and/ or cartons.

 10. The QA Associate will complete the QARN (QA Rejection Notification) and forward a copy to the Logistics department. A copy will be placed in the relevant batch record and the original will be filed in the QARN folder located the QA office.

 11. Disposal of rejected material:

 a. Where applicable, Logistics will raise a SRN (Stock Rejection Notification), move material to a reject location and arrange for its disposal. 

 b. If the product is an ‘in-process’ bulk, Production will arrange disposal and return the SRN to Logistics once complete.

 12. Return to supplier of rejected material:

 a. Where rejected material is to be returned to the supplier, Purchasing will raise a ‘Return to Supplier’ form and arrange for the material to be returned.