SOP for Status Label in Production

Standard Operating procedure (SOP) for identification and status label/labeling procedure of product, accessories equipment, and various manufacturing areas.

Status Label/Labelling Procedure

PURPOSE:

To lay down the identification and status labeling procedure of Products, Containers, Accessories, Equipment, and Areas.

SCOPE:

This procedure is applicable to the WIP labels used in Warehouse, Granulation, Compression, Coating, Packing & Engineering departments at the pharmaceutical drug manufacturing plant.

REFERENCES:Status Label

  • In House

RESPONSIBILITY:

    • Production officer shall be responsible to affix the appropriate status label with required details as per present status on Products, Containers, Accessories, Equipment, and Areas.
    • The production officer shall be responsible to generate system-generated status labels.
    • QA shall be responsible for the implementation of the status label/labeling procedure as per SOP.

ABBREVIATIONS USED UN SOP OF STATUS LABEL:

    • BMR: Batch Manufacturing Record
    • Dept: Department
    • GMP: Good Manufacturing Practice.
    • NLT: Not Less Than
    • QA: Quality Assurance
    • SOP: Standard Operating Procedure
    • WIP: Wash In Process
    • DEFINITION: NA

PROCEDURE FOR STATUS LABEL / LABELING :

    • In order to avoid mix-ups and contamination, for easy identification and traceability of product and to ensure working as per GMP standards it is important to affix status labels at each stage of the process on equipment, products, containers, accessories, and areas.
    • Status Labels of various types are used in manufacturing functions.
    • Category of Status Labels:

    • SAP/ERP/Metis generated labels
    • Computer-generated labels
    • Printed labels
    • Manufacturing and packing supervisors will generate the required number of WIP labels and other status labels from the SAP/ERP/Metis system.
    • Follow the below steps to generate labels from SAP/Metis.
    • —>Inquiry—> Mfg. Coupons—>Under Process
    • Enter the required input in the window of the respective label.

    • The total number of containers shall be included to get the container number preprinted in the label.
    • WIP labels to be used at various stages of manufacturing shall be generated as per Annexure-1.
    • Content/Format of the WIP labels to be used at various stages of manufacturing will be generated as per Annexure-2.
    • All labels except SAP/Metis generated status labels should have sun pharma logo as the header, title of the label, reference SOP number and address as footer.
    • In process labels shall be affixed with BMR/BPR.
    • Other status labels will be defaced and destroyed immediately after processor usage.
    • The Colour of the label to be used for each stage is defined in annexure.
    • In the case of the sap/Metis system is not working, generate the status label through the computer on the same standard format or contents of labels.

DISTRIBUTION OF STATUS LABEL SOP:

    • Production
    • Maintenance
    • Warehouse
    • Quality Assurance
    • Quality Control

ANNEXURES OF STATUS LABEL:

Annexure 1: Labels used at various stages of product manufacturing /packing/Warehouse.

SOFTWARE GENERATED STATUS LABEL

WIP labels

Stage

Area Label Type Status Label Size (W/H)cm

Label Color

Under Quarantine Warehouse Quarantine 10X9 Yellow
Retest Warehouse Retest Quarantine 10X7 Yellow
Dispensing Warehouse Material issue coupon 10X6.6 White
Post dispensing Warehouse Dispensed Material 10X9 White

 

In process Labels

Ready for Sifting/Milling Granulation In process 10X7 White
Ready for Binding Granulation In process 10X7 White
Ready for Drying Granulation In process 10X7 White
Ready for Lubrication Granulation In process 10X7 White
Ready for Slugging Granulation In process 10X7 White
Ready for De slugging Granulation In process 10X7 White
Ready for Capsule Filling Granulation/

Coating

In process 10X7 White
Ready for Compression Granulation

 

In process 10X7 White
Ready for Coating Compression In process 10X7 White
Ready for Sachet Filling Granulation In process 10X7 White
Ready for Bottle Filling Granulation In process 10X7 White
Ready for Sorting Compression/

Coating

In process 10X7 White
Packing Slip Packing In process 10X7 White

 

Equipment Label (Under process)
Equipment status All department Under process 10X7 White
Under Process Quarantine
Ready for Packing Compression/

Coating/Capsule

Under Process Quarantine 10X7 White
ITW Generated Label
Packing Slip Packing In process Packing Slip Packing

 

Computer Generated Labels:

 

Stage Department Label Size of Label (W/H)cm

Color of the label

Cleaning status of RLAF Warehouse Filter Clean Card 10X9 White
For Psychotropic API dispensing Warehouse Partly dispensed for Psychotropic API 10X9 White
For damage or spilled material Warehouse Spilled/Damaged Material 10X9 White
To Hold any material. Warehouse Hold 10X9 White
Partly Dispensing of Excipients Warehouse Partly Dispensed for Excipients 10X9 White
Partly Dispensing of API Warehouse Partly Dispensed for API 10X9 White
Identification of Balance General Balance Operating tag 10X9 White
Calibration Status of Balance General Calibration Status of balance 10X9 White
10% HEMAC 4 Housekeeping 10% HEMAC 4 10X9 White
2.5% Dettol Housekeeping 2.5% Dettol 10X9 White
2% Non-ionic Housekeeping 2% Non-ionic 10X9 White

 

Printed Labels:

Stage Department Label Size of Label (W/H)cm Color of the label
“Type Cleaning General Cleaned Card 11X8.5 Green
To be Cleaned General To be Cleaned 12X6.5 Red
“Type Cleaning for dismantles part of the machine. General Cleaned label for dismantling part 12.5X4 Green
“Type A ”cleaning General Partially Cleaned 11X8.5 Red
Recovery of a Batch General Recovery 11.5X5.5 Orange
Non Recovery of a Batch General Non-Recovery 11.5X5.5 Pink
Qualification status of machines General Qualification 13X8mm Grey Color Metallic
Status of an area General Status Label 12X8mm Grey Color Metallic
Preventive maintenance status. General Preventive maintenance 12X8mm Grey Color Metallic
Finish product sampling QA Sample for analysis 6X6 White
Sampling during In Process. QA/Production Sample for In-Process 6X6 White
Under Maintenance Engineering Maintenance 12X5.5 White

 

Annexure 2: Formats/ Contents of Status Label

  1. QUARANTINE LABEL

    • QUARANTINE LABEL
    • ITEM CODE RAW MATERIAL SERIES
    • ITEM NAME
    • GIM NO : DATED:
    • BATCH NO: LOT SL:
    • MFG DATE :
    • EXP DATE: AR NO:
    • QUANTITY :
    • PACKAGE NO:
  1. RETEST QUARANTINE

RETEST QUARANTINE

Item code

Item Name

A.R No.                                           Quantity:

Lot SL.                                            Location Code:

Retest Date:                                    Expiry Date:

Sampled By:                                   Date:

 

  1. MATERIAL ISSUE COUPON

Product:

Batch No. :                                 Operation :

Material:             Balance No:

Code No:                    Location Code:

A.R No:

Package No:

Received and Checked By

Production Dept.

Tare Weight  :
Net Weight    :
Gross Weight:
Weighed By
(WH)
Weighed By
(WH)

 

  1. DISPENSED MATERIAL

DISPENSED MATERIAL

Product :

Batch No:                                      Operation:

Stage :                                            Lots :

Container no:

Material Dispensed By:

Material Dispensed Date:
Work order issue no:

  1. IN-PROCESS LABEL

IN-PROCESS

Bar code

Product Name

Batch no.                                   Process size:

Stage :

Container No:                 Lots:

Performed By:          Use before:           Checked By:

Date:  Date

  1. UNDERPROCESS LABEL/EQUIPMENT STATUS LABEL

EQUIPMENT

Product Name

Batch no.

Batch size:

Mfg. Date:                                         Exp. Date:

Stage: U/PROCESS

Machine:

Checked by:                                      Date:

  1. UNDER PROCESS QUARANTINE

UNDER PROCESS QUARANTINE

Bar code

Product Name

Batch no.                                       Process size:

Stage :

Container No:                 Lots:

Performed By:                Use Before:         Checked By:

Date:  Date:

 

  1. PACKING SLIP (ITW GENERATED)

PACKING SLIP SHIPPER NO:

PRODUCT :

BATCH NO :

MFG. DATE :

EXP DATE :

QUANTITY :

G.WT :

PACKED BY :

SIGNATURE : DATE:

STORAGE :

  1. FILTER CLEAN CARD (COMPUTER GENERATED)

FILTER CLEAN CARD

CLEANING DONE ON:

CLEANING DUE ON:

CHECKED BY/DATE:

  1. SPILLED OR DAMAGED MATERIAL (COMPUTER GENERATED)

SPILLED/DAMAGED MATERIAL

Item Code :

Item Name:

A.R no :

Quantity :

 

  1. HOLD LABEL (COMPUTER GENERATED)

HOLD LABEL

Product :

Batch No./A.R No.:

Stage :

Reason of Hold :

Hold By QA :

(Signature/Date)

  1. PARTLY DISPENSED CONTAINER LABEL

PARTLY DISPENSED

NAME of RM: TOTAL NET QUANTITY OF CONTAINER:

A.R. No: CONTAINER No:

DETAILS OF QUANTITY DISPENSED

SR NO DATE DISPENSED QTY(KGS) BALANCE QTY(KGS) PRODUCT BATCH NO DATE
             

 

 

  1. PARTLY DISPENSED CONTAINER LABEL FOR PSYCHOTROPIC DRUGS

PARTLY DISPENSED FOR PSYCHOTROPIC

Container No-

Material- Item Code- Received Date-

Mfg. Batch No- Mfg. Date- Exp. Date –

AR No –                              GIM No – Received Qty –

DETAILS OF QUANTITY DISPENSED

 

Date Product Batch No. Dispensed Balance Gross Wt. Outer Tie Inner Tie Done
By
                 

 

  1. CLEANED CARD

CLEANED LABEL ( TYPE-B CLEANING) 

EQUIPMENT/AREA NAME: ………..

PREVIOUS PRODUCT:…………..

BATCH NO:…………….

CLEANED BY: …………DATE:……….

CHECKED BY(PRODUCTION):……… DATE:………

USE ON BEFORE:…………..

APPROVED BY(QA): ………………..

TO BE USED FOR ………………….

PRODUCT:……………….

BATCH NO:………………

 

  1. PARTIALLY CLEAN CARD

PARTIALLY CLEANED CARD ( TYPE-A CLEANING)

EQUIPMENT/AREA NAME:…………

PREVIOUS PRODUCT:……………..

BATCH NO:………….

CLEANED BY: …………….DATE:………………

CHECKED BY(PRODUCTION):……………. DATE:……….

USE ON BEFORE:…………..

APPROVED BY(QA):…………….

TO BE USED FOR:………………..

PRODUCT:………………….

BATCH NO:……………..                         

  1. TO BE CLEANED

TO BE CLEANED

EQUIPMENT NAME:…………………….

PREVIOUS PRODUCT:……………….

BATCH NO:……………..

SIGN:……………….. DATE:………………

  1. CLEANED LABEL FOR DISMENTAL PARTS

CLEANED BY:……………. DATE & TIME:…………………

CHECKED BY: ……………DATE & TIME:…………….

USE ON BEFORE:……………. TIME:………………….

 

  1. RECOVERY

RECOVERY

PRODUCT NAME: …………………

BATCH NO:……………. QTY IN KG:…………

DATE: ……………SIGNATURE:…………

 

  1. NON-RECOVERY

NONRECOVERY

PRODUCT NAME:………………………

BATCH NO: QTY IN KG:……………….

DATE: ……………….SIGNATURE: ………………

 

  1. SAMPLE FOR ANALYSIS SAMPLE FOR INPROCESS

SAMPLE FOR ANALYSIS

PRODUCT NAME:…………..

BATCH NO: …….BATCH SIZE:……..

MFG DATE:………. EXP DATE:……..

STAGE:……. NO OF CONTAINER:…..

SAMPLED QTY:……………..

SAMPLED BY/DATE:…………….

 

SAMPLE FOR INPROCESS 

PRODUCT NAME:……………..

BATCH NO :……………

SAMPLED FROM:………….

STAGE :……………

SAMPLED BY/DATE:…………

 

  1. QUALIFICATION LABEL PREVENTIVE MAINTENANCE LABEL

QUALIFICATION LABEL

NAME OF THE EQUIPMENT :

EQUIPMENT CODE:

QUALIFICATION DONE ON:

QUALIFICATION DUE ON:

QA SIGN/DATE

 

PREVENTIVE MAINTENANCE LABEL

EQUIPMENT ID NO.

LOCATION:

PM DONE ON:

PM DONE BY

NEXT DUE DATE:

CHECKED BY(ENG.): VERIFIED BY USER:

 

  1. UNDER MAINTAINANCE AREA STATUS LABEL

UNDER MAINTAINANCE

EQUIPMENT:                        EQUIPMENT NO:

PREVIOUS PRODUCT:        BATCH NO:

SIGNATURE:                         DATE :  

 

STATUS LABEL

PRODUCT NAME :

BATCH NO :

MFG DATE :

EXP DATE :

STATUS :

CHECKED BY : DATE:

 

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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