Department | Quality Management | Document no | QMS-075 | ||
Title | Procedure for Product Identification and Traceability | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
Document Owner
Quality Assurance Manager
Affected Parties
All manufacturing colleagues
Purpose
The purpose of this SOP is to define the method used for the identification of all contributing materials that could effect product quality used in the manufacture of product, and the final product, to ensure their full traceability.
Scope
Staffs are responsible for conducting required checking procedures as documented in the relevant SOPs pertaining to the activity being conducted.
Definition
| N/A |
Related Documents
WAR-005 | Receipt of Incoming Goods |
MAN-055 | Procedures for Line Clearance, Line Opening and Line Cleaning |
MAN-090 | Scheduling Production Lines |
WAR-010 | Raw Material and Components-Incoming-Handling by Sampler. |
EHS Statement
There is no EHS impact.
Procedure
1. Introduction
Product traceability system allows for complete and up to date histories of all batches of products from the starting materials to the complete final product. Identification and status of materials is provided by unique and controlled numbering system. The system can be interrogated to provide reports to allow for full traceability.
2. General Overview
2.1. Inwards goods
2.1.1. Materials/Components are identified at the time of receipt. Each material has a unique identifying number. At the time of receipt each material shipment is given an unique Laboratory batch number. QA team maintains the full list of raw material and component codes, description and approved suppliers/manufacturers.
2.1.2. The vendor’s batch number of the imported raw materials are maintained all through the process steps associated with the unique Laboratory batch numbers.
2.1.3. The raw material code number is allocated and maintained by the Quality Assurance Team. Laboratory batch number is given by Warehouse team.
2.1.4. Each shipment of raw material is given an unique Goods Receipt Slip number. The combination of unique material code, Laboratory batch number and Good Receipt Slip number allows warehouse team a good traceability during storing and issuing materials to production.
2.2. Finished Goods Production
2.2.1. All Finished Goods manufactured require two sets of numbers that identify the product type and the unique batch number. Each manufactured product type is identified by unique product code. Each manufactured batch is identified by unique Batch Production Number.
2.2.2. The Finished Goods number is assigned and controlled by the Quality Assurance team.
2.2.3. The Finished Goods batch number is allocated by the Planner sequentially on conversion of a Planned Order and a batch production Order. The unique Batch Production Number is used to trace all processing steps for the Production Operation.
2.2.4. Product identification is noted on the Certificate of Analysis at testing.
2.2.5. Product traceability is progressively recorded in the Manufacturing Instruction (MI) system.
2.2.6. The product code, Batch Production Number and Goods booking Slip Number in combination produce the system which traces the distribution, recall and destruction of all Finished Goods.
3. Details of Identification
3.1. All items arriving on the premises, intended to be used within the processing of finished products carry permanent, unique numbers allocated of material code, Laboratory batch number and Goods receipt slip number. The Code number, Batch Number and the GRS number form the foundation to ensure traceability of the component/material/unit. The Receiving procedure describing booking in of the goods into the system, including allocation of the Batch Numbers, is covered in SOP WAR-005.
3.2. Warehouse to assign GRS number on the GRS form. Each GRS number is an eight digit number in the format of YYXXXXXX, starting with the last two digits of the year, followed by a consecutive number up to 100000 deliveries started from 000001.
For example: GRS number for 10th delivery of the year 2005 will be 05000010.
3.3. Warehouse to assign Laboratory batch numbers for any given material code. Each laboratory batch number is a 10 digit number in a format of YY.MM.000000. Where, YY represents the last two digits of the year and MM represents the month, followed by a consecutive number up to 100000 deliveries starting from 000001.
3.4. Bin Sheets are created to identify every pallet of incoming raw material, which will contain information of a unique material number and laboratory batch number.
3.5. Material Transfer Orders are created by production, which links raw material/component code number and lab. batch number with the subsequent product code and Batch Production Number.
3.6. Production assigns a Material Transfer Order number in a format of LX-YYYYYY.
Where,
L = Line
X = Line number
YYYYYY is a consecutive number starting at the beginning of the year form 000001 and ends up in that year.
The storage type and storage bin number for material/component storage is allocated on the material transfer order forms.
3.7. All containers or other packaging units must be appropriately labelled by site Identification labels so that their category, classification and status are determined. The procedure is defined in SOP WAR-005.
3.8. Processing of raw materials into product that is packaged will be allocated a Batch Production number by the respective production planner in the format of YYXXXX
Where,
YY = last two digits of the year.
XXXX = Sequential number starts from 0001 for the corresponding year.
3.9. Each batch is identified by the unique Product Code Number. QA team maintains the full list of Product code, description and specification numbers.
3.10. Goods Booking Slip Number is allocated by production planner to identify each pallet of a Batch booked out of the production line. Each GBS number is an eight digit number in the format of YYXXZZZZ, starting with the last two digits of the year, followed by a two digits of the month. A consecutive four digits number is assigned up to 1000 booking of batches started from 0001.
For example: GBS number for 10th delivery of the month of June, year 2005 will be 05060010.
The storage type and storage bin number for product storage is allocated on the Goods Booking Slips.
3.11. Pallet IDs are created to identify every pallet of manufactured finished goods, which will contain information of a unique Product code and Batch Production Number.
3.12. All steps throughout the Manufacturing Process are tracked via Manufacturing Instruction (MI) documents, maintained by the Technical Service team unique for each product code.
3.13. Full traceability is assured through issuing appropriate documentation and maintaining records that accompany every step in batch manufacturing.
4. Status
4.1. All components, Raw Materials and Finished Products undergo inspection and testing at various stages of their processing to verify their adherence or otherwise to standards which is detailed in relevant documentation.
4.2. On completion of every inspection and test procedure, resulting in a change to the status of the item a record is generated to attest that the item is allowed to proceed to the next stage in its processing.
4.3. The change in status of a product/batch can be marked by various ways like Authorized persons signature and date on the forms and records, applying stickers e.g. RELEASED sticker.
4.3.1. Only authorized warehouse person will receive incoming goods and sign and date on the Goods Receipt Slips. Authorized dispensary personnel will sample the Raw material/component laboratory testing. Authorized production personnel will request material/component for a BPN through Material Transfer Orders. Authorized laboratory personnel will test Raw Materials, Components and Finished Goods according to approved Specification and Test Reports. In each of the case the material or batch status will be changed, which is reflected by authorized persons sign and date on the forms and record. Appropriate stickers are applied to mark those changes.
4.3.2. Goods undergoing manufacturing are continuously in process tested, the status “done/not done” is noted when the entry is made in the Manufacturing Instructions.
5. Records
The completed Manufacturing Instruction (MI) sheets form the record of batch production.
Summary of Changes
Version # | Revision History |
QMS-075 | New |