SOP on Status Labeling System and Its Control

0
618

1.0 Objective: To lay down a procedure for the status labeling system and its control.

2.0 Scope: This Standard Operating Procedure is applicable for identification labels and status labels used in pharmaceutical company.

3.0 Responsibility

3.1 All concerned department personnel & their HODs are responsible for implementation and execution of status labeling.

3.2 QA personnel shall responsible for checking, implementation & control of status labeling.

4.0 Accountability

4.1 Department Heads & QA Head shall be accountable for implementation of this SOP.

5.0 Abbreviations and Definitions:

Initiator Department   :  Department who shall initiate the preparation of SOP.

SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.

6.0 Procedure

6.1 Label shall be filled by respective person by following SOP on GDP.

6.2 Adequate information shall be filled by respective personnel on labels.

6.3 At the time of use, label shall be filled manually (except labels generating from software) by using blue ball pen, only QA personnel shall use black ball pen.

6.4 Any information should not be blank.

6.5 Information on label shall be filled as instructed on respective label.

6.6 Doer & checker of concerned activities and department shall signature the label or as directed on label.

6.7 The labels generating from software shall have a unique format number.

6.8 Contents of Status Label

6.8.1 All labels shall have a unique format no. which shall be written on bottom left side of label in font size 10.

6.8.2 All status label shall be surrounded by a boarder of ½ pt.

6.8.3 Contents of status label shall differ for all. It shall be depend on activities performed.

6.8.4 Status label shall be color specific as described under individual annexure.

6.8.5 Size of label shall be fixed as per suitability, it is described under individual annexure.

6.8.6 Labels shall be of sticker, card type or generated by computer. Details of the type shall be described in the respective specimen of the labels.

6.8.7 All label shall have company logo & company name (in font size 12).

6.8.8. Font size shall be fixed as per suitability for all labels, but font type times new roman shall use for all.

6.8.9 Spacing between contents shall be as per suitability.

6.9 The detail of the in process status labels along with department responsible for handling the same are given below:-

6.9.1 Quarantine-Under Test

6.9.1.1 After received the consignment from manufacturer/supplier Quarantine under test label shall be affixed.

6.9.1.2 Specimen copy is attached in Annexure-I.

6.9.2 Sampled Slip

6.9.2.1 After sampling of RM/PM sampled slip shall be affixed.

6.9.2.2 Specimen copy is attached in Annexure-II.

6.9.3 Release Slip (Label for Approval)

6.9.3.1 After analysis of incoming material, if material complies with the respective material specification, QC shall release the material by affixing release slip label on incoming material.

6.9.3.2 Specimen copy is attached in Annexure-III.

6.9.4 Rejection Slip

6.9.4.1 After analysis of incoming material, if material does not complies with the respective material specification, QC shall reject the material by affixing rejection slip label on incoming material.

6.9.4.2 This label be print using ERP on red color sheet.

6.9.4.3 Specimen copy is attached in Annexure –IV.

6.9.5 Dispensed Label

6.9.5.1 The “Dispensed” Label shall be used to indicate that material has been dispensed in Dispensing Area.

6.9.5.2 Specimen copy is attached in Annexure -V.

6.9.6 Online Rejection

6.9.6.1 During manufacturing process if any material shall reject on line it shall be labelled as online rejection.

6.9.6.2 Specimen copy is attached in Annexure -VI.

6.9.7 Status Label

6.9.7.1 All the Products lying in the area to be Identify with Status Label indicate the status of the product.

6.9.7.1 Specimen copy is attached in Annexure -VII.

6.9.8 To be Cleaned Label

6.9.8.1 The “To be cleaned” Label shall be used to indicate that the Equipment is not cleaned

6.9.8.2 Specimen copy is attached in Annexure -8.

6.9.8.3 Note: In an area, if any equipment is not in use although a product is running on other equipment, in that case after completion of the product/ batch, affix, To Be Cleaned label on both used and unused equipment’s, previous product will be the product which was last run on that particular equipment (as per log book). Clean the equipment’s as per next product/ batch, which is to take under process. After cleaning, replace “To be Cleaned label” with “Cleaned label”.

6.9.9 Cleaned Label

6.9.9.1 The “Cleaned” Label shall be used to indicate that the Equipment is in cleaned condition and ready for use for the next batch / product.

6.9.9.2 Specimen copy is attached in Annexure -IX.

6.9.10 Container / Bin Status Label

6.9.10.1 All the material / product which shall be store in a container / bin to be identified with “Container / Bin Status” Label and indicate the details of the material.

6.9.10.2 Specimen copy is attached in Annexure -X.

6.9.10.3 Additional space in bottom in this label is given for affixing label for detailing of the under test and approval status.

6.9.11 To Be Inspected Label

6.9.11.1 The “To Be Inspected” Label shall be used to indicate that the product is to be inspected on an Inspection Belt.

6.9.11.2 Specimen copy is attached in Annexure -XI.

6.9.12 Inspected Label

6.9.12.1 The “inspected” Label shall be used to indicate that the product has been inspected and found as good after the inspection.

6.9.12.1 Specimen copy is attached in Annexure -XII.

6.9.13 Recoverable Rejection Label

6.9.13.1 The “Recoverable Rejection” Label shall be used to indicate that the product rejects at any stage can be recovered as a product of intended standard after reprocessing.

6.9.13.1 Specimen copy is attached in Annexure -XIII.

6.9.14 Non Recoverable rejection Label

6.9.14.1 The “non-recoverable rejection” Label shall be used to indicate that the product is not to be added in the next product and subjected for the destruction.

6.9.14.1 Specimen copy is attached in Annexure -XIV.

6.9.15 Loose box Label

6.9.15.1 The “Loose box” Label shall be used for the packed corrugated box containing the packed finished product which does not contain the standard quantity for a complete corrugated box.

6.9.15.1 Specimen copy is attached in Annexure- XV.

6.9.16 In Process Under Test Label

6.9.16.1 The “In process under test” Label shall be used to indicate that the In process Product has been sampled and send to quality control Department for analysis and the release is awaited.

6.9.16.2 Specimen copy is attached in Annexure -XVI.

6.9.17 Under Hold Label

6.9.17.1 The “Under Hold” Label shall be used when some non-conformation or out of specification finding and not to be taken for further process till proper documentation clearance for activity is not done.

6.9.17.2 Specimen copy is attached in Annexure -XVII.

6.9.18 In Process Rejected Label

6.9.18.1 The “In Process Rejected” Label shall be used to indicate that the product or material has been rejected during the operation of any process (such as online rejection for foils) or the product is rejected during in process (such as in process sample/ in process loss) and not to be taken for next process and subjected for destruction /return to the vendor/subjected for further analysis.

6.9.18.2 Specimen copy is attached in Annexure -XVIII.

6.9.19 Under Installation Label

6.9.19.1 The “Under Installation” Label shall be used to indicate that the equipment is under installation.

6.9.19.1 Specimen copy is attached in Annexure -XIX.

6.9.20 Under Maintenance Label

6.9.20.1 The “Under Maintenance” Label shall be used to indicate that the equipment/ area is under maintenance.

6.9.20.2 Specimen copy is attached in Annexure -XX.

6.9.21 Approved Label

6.9.21.1 The “Approved” Label shall be used to indicate that the product is released by quality control department after analysis. After approval product is ready for the release for the next process.

6.9.21.2 Specimen copy is attached in Annexure -XXI.

6.9.22 Sample For Analysis Label

6.9.22.1 The “Sample for analysis” Label shall be used to store and transfer the sampled specimen of drug product for analysis.

6.9.22.2 Specimen copy is attached in Annexure-XXII.

6.9.23 Calibration Status Label (For In house & External calibration)

6.9.23.1 The calibration status label shall be used on equipment/instrument which is calibrated in-house as per given schedule.

6.9.23.1 Specimen copy is attached in Annexure -XXIII.

6.9.23.3 If calibration shall be done by external party than label shall be of their standard, but label shall have following minimum information but not limited to:

  • Equipment/ instrument ID No.
  • Calibration date
  • Due date of calibration
  • Date & Sign. of doer

6.9.24 Scrap Label

6.9.24.1 The “Scrap” Label shall be used to store and transfer the non-recoverable material other than drug component of product.

6.9.24.2 Specimen copy is attached in Annexure- XXIV.

6.9.25 Equipment Status Label

6.9.25.1 Equipment status label shall be used on equipment to indicate the status of equipment.

6.9.25.2 Specimen copy is attached in Annexure -XXV.

6.9.26 Sampled Slip (Bulk product sampling)

6.9.26.1 After sampling of bulk product sampled slip shall be affixed.

6.9.26.2 Specimen copy is attached in Annexure -XXVI.

6.9.27 Passed Slip (Bulk Product)

6.9.27.1 After sampling of bulk product slip shall be affixed.

6.9.27.2 Specimen copy is attached in Annexure -XXVII.

6.10 Inventory of Status label

6.10.1 Inventory of all status label shall be maintained as per annexure -XXVIII by QA as these are the formats.

6.11 Issuance of Status label

6.11.1 Issuance of all status label shall be same as format issuance as per SOP on format control.

6.12 Archival of Status label

6.12.1 Archival of filled status label shall be the part of respective batch no. BMR.

6.12.2 When the batch activities shall be completed all the respective status label shall be attach with BMR.

6.12.3 Labels which shall not be the part of BMR shall be send to QA by respective department after completion of their valid period.

6.12.4 These labels shall be destroyed by QA as per SOP on destruction.

6.13 Labels printing specification shall be as described in annexures.

6.14 However, the list of labels along with format numbers (updated list) shall be maintained by QA as per annexure -XXIX. Furthermore the format number for a newly introduced label shall also be assigned after reviewing the format number list, in order to avoid repetition, and this case SOP will be revised.

7.0 Forms and Records (Annexures)

7.1 Quarantine-Under Test  – Annexure-I

7.2 Sampled Slip – Annexure-II

7.3 Release Slip – Annexure-III

7.4 Rejection Slip- Annexure-IV

7.5 Dispensed Label – Annexure-V

7.6 Online Rejection – Annexure-VI

7.7 Status Label – Annexure-VII

7.8 To be Cleaned Label –  Annexure-VIII

7.9 Cleaned Label – Annexure-IX

7.10 Container / Bin Status Label – Annexure-X

7.11 To Be Inspected Label- Annexure-XI

7.12 Inspected Label – Annexure-XII

7.13 Recoverable Rejection Label – Annexure-XIII

7.14 Non Recoverable rejection Label- Annexure-XIV

7.15 Loose box Label  – Annexure-XV

7.16 In Process Under Test Label – Annexure-XVI

7.17 Under Hold Label – Annexure-XVII

7.18 In Process Rejected Label  – Annexure-XVIII

7.19 Under Installation Label –  Annexure-XIX

7.20 Under Maintenance Label – Annexure-XX

7.21 Approved Label – Annexure-XXI

7.22 Sample For Analysis Label – Annexure-XXII

7.23 Calibration Status Label – Annexure-XXIII

7.24 Scrap Label – Annexure-XXIV

7.25 Equipment Status Label – Annexure-XXIV

7.26 Sampled Slip (Bulk Product Sampling) –  Annexure-XXVI

7.27 Passed Slip (Bulk Product)  –  Annexure-XXVII

7.28 Inventory Control Logbook for Status Labels – Annexure-XXVIII

7.29 List of Status Labels– Annexure-XIX

8.0 Distribution

8.1 Master copy –           Quality Assurance

8.2 Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering, HR.

9.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

 

                                                                 Annexure-I

                                                    QUARANTINE-UNDER TEST

 Company Logo                      QUARANTINE-UNDER TEST
Material Name __________________________________Date of Receipt____________

GRN No________________________Batch No. ______________Qty.______________

Mfg. Date______________________Exp. Date_______________Container No._______

Mfd. by ____________________________Supplied by___________________________

Sign & Date _____________________________________________________________

Form No.- SOP/QA-000/F01-00

Specification: printing black

Size: 110 x 80mm ± 2mm

Type: Sticker Type

Annexure-II

Sampled Slip

       Company Logo                    SAMPLED SLIP
ITEM:
B.NO.:                                                  CONTAINERS:
QUANTITY:
DATE OF RECEIPT:                           EXP DATE:
SUPPLIED BY:
MFG BY:
GRN NO.
Sampled Qty.                                    Sampled On:
Sampled By:                                     Signature:

Specification: Yellow colour sheet, printing black

Size: 110 x 80mm ± 2mm

Type: Sticker Type

Annexure-III

For Raw Material

Company logo                                                       Quality Control Department

                                                 RELEASE SLIP

Item :      
Batch No. :   Container No. :  
Supplier :   Quantity :  
Manufacturer :   Sampled On :  
Q.C.Ref. No. :   Exp. Date :  
Accepted Qty. :   Test Compl. Date. :  
Rejected Qty. :   Result :  
Release Valid Till :      
 Tested By     Signature    

Specification: Green colour sheet, printing black

Size: 110 x 80mm ± 2mm

Type: Sticker Type

Annexure-IV

For Raw Material

Company Logo Quality Control Department

                                    REJECTION SLIP                                          

Item :      
Batch No. :   Container No. :  
Supplier :   Quantity :  
Manufacturer :   Sampled On :  
Q.C.Ref. No. :   Exp. Date :  
Accepted Qty. :   Test Compl. Date :  
Rejected Qty. :   Result :  
Release Valid Till :      
Tested By        Signature    

Specification: Red colour sheet, printing black

Size: 110 x 80mm ± 2mm

Type: Sticker Type

Annexure-V

Dispensed Label 

  Company Logo                                            Dispensed Label 
Material Name /Item Code__________________________________________________

A.R. No._________________________ Batch No.______________________________

Mfg. Date_________________________ Exp. Date_____________________________

For Product _____________________________________________________________

Product Batch No. ________________________________________________________

Gross Weight (Kg.) Tare Weight (Kg.) Net Weight (Kg.)
Dispensed by (Sign / Date) Received by (Sign / Date) Verified by (Sign/Date)
Form No.- SOP/QA-000/F01-00

Specification: printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-VI

         Online Rejection

Company logo                                             Online Rejection
Material Name
A.R. No.
Product & Batch No.
Qty. Returned
Remarks:
Signature & Date
 (Production Officer)   (IPQA Officer)
Form No.: SOP/QA-000/F01-00

Specification: Red strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-VII

 Status Label

Company Logo                                                 Status Label
Product Name ___________________________________________________________

Batch No. _____________________________ Batch Size _______________________

Mfg. Date____________________________ Exp. Date__________________________

Stage__________________________________________________________________

Next Stage______________________________________________________________

 

Checked by (Sign / Date)
Form No.- SOP/QA-000/F01-00

Specification: printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-VIII

Company logo       

 To be cleaned

Equipment / Bin / Container ________________________________________________

I.D. No._________________________________________________________________

Previous Product _________________________________________________________

Batch No. _______________________________________________________________

Checked By  (Sign / Date/Time)
Form No.- SOP/QA-000/F01-00

Specification: Dark Orange, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-IX

Company logo       

Cleaned

Equipment / Bin / Container ________________________________________________

I.D. No._________________________________________________________________

Previous Product _________________________________________________________

Batch No. _______________________________________________________________

Type of cleaning__________________________________________________________

Done On  ____________________________     Use Before _______________________

Done by (sign / date)__________________ Checked by (sign / date/time)___________
Remarks (If any)_________________________________________________________

Checked By IPQA (Sign/Date/Time)_________________________________________

Form No.- SOP/QA-000/F01-00

Specification: Green strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-X

Company Logo                                                       Container/Bin Status
Product Name __________________________________________________________

Batch No.______________________________  Batch Size ______________________

Mfg. Date_____________________________  Exp. Date________________________

Stage__________________________________________________________________

Container / Bin no.  ______________________________________________________

Gross weight (kg) Tare weight (kg) Net weight (kg)
Checked by: (sign / date)
                                                     Affix Status Label Here
Form No.- SOP/QA-000/F01-00

Specification: printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Area of bottom empty space: 25 mm

Annexure-XI

Company Logo

  TO BE INSPECTED

Product Name___________________________________________________________

Batch No.______________________________________________________________

Mfg. Date______________________________________________________________

Container No.___________________________________________________________

Quantity_______________________­­­­­­­­________________________________________

Checked by (Sign/Date):
Form No.- SOP/QA-000/F01-00

Specification: Yellow strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XII

Inspected Label

Company Logo

  INSPECTED

Product Name___________________________________________________________

Batch No.______________________________________________________________

Mfg. Date______________________________________________________________

Container No.___________________________________________________________

Quantity_______________________­­­­­­­­________________________________________

Checked by (Sign/Date): Verified by (Sign/Date):
Form No.- SOP/QA-000/F01-00

Specification: Green strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XIII

 Company Logo

 Recoverable Rejection

Product Name ___________________________________________________________

Batch No. _________________________________ Batch Size ____________________

Mfg. Date__________________________  Exp. Date____________________________

Quantity _______________________________________________________________

Stage__________________________________________________________________

Checked by(sign / date) Verified by(sign / date)
Form No.- SOP/QA-000/F1-00

Specification: Red colour strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XIV

 Company Logo

Non-Recoverable Rejection

Product Name ___________________________________________________________

Batch No. _________________________________ Batch Size ____________________

Mfg. Date__________________________  Exp. Date____________________________

Quantity _______________________________________________________________

Stage__________________________________________________________________

Checked by(sign / date) Verified by(sign / date)
Form No.- SOP/QA-000/F1-00

Specification: Red colour strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XV

Company Logo    

Loose Box 

Product Name ___________________________________________________________

Operator Name __________________________________________________________

Batch No. ________________________________ Batch Size _____________________

Mfg. Date_______________________________  Exp. Date_______________________

Quantity in Box  _________________________________________________________

Checked by (Sign / Date) Verified by (Sign/Date)
Form No.- SOP/QA-000/F1-00

Specification: printing black

Size: 110 x 80mm ± 2mm

Type: Sticker Type

Annexure-XVI

 Company Logo   

COMPANY NAME

IN PROCESS UNDER TEST 

Stage:                                                                                                                     Sign/ Date:

Form No.- SOP/QA-000/F1-00

Specification: Yellow strip, printing black

Size: 100 x 20mm ± 2mm

Type: Sticker Type

Annexure-XVII

 Company Logo   

 Under Hold

Product Name ___________________________________________________________

Batch No. _______________________________________________________________

Stage __________________________________________________________________

Quantity________________________________________________________________

Reason for hold__________________________________________________________

Remark_________________________________________________________________

Hold by (Sign / Date):
Form No.- SOP/QA-000/F1-00

Specification: printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XVIII

Company Logo    

In Process Rejected

Material name /Item code___________________________________________________

Product Name____________________________________________________________

Batch No.____________________________ Rejected Quantity____________________

Container No._____________________ Stage__________________________________

Reason for Rejection______________________________________________________

Remark ________________________________________________________________

Rejected by (Sign / Date)
Rejected
Form No.- SOP/QA-000/F1-00

Specification: Red strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XIX

Company Logo    

 Under Installation

Equipment Name_________________________________________________________

Area ___________________________________________________________________

Checked by (Sign / Date)
Form No.- SOP/QA-000/F1-00

Specification: Light purple, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XX

Company Logo    

 Under Maintenance

Equipment Name/Area_____________________________________________________

ID No.__________________________________________________________________

Location________________________________________________________________

Reason _________________________________________________________________

Checked by (Sign / Date) :
Form No.- SOP/QA-000/F1-00

Specification: Brown Strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XXI

Approved Label

 Company Logo       COMPANY NAME

Approved

Product Name:                                                         Batch No.:

A.R.No.:_________________________________Stage_________________________ 

Approved by (Sign/ Date) :

Form No.- SOP/QA-000/F1-00

Specification: printing black

Size: 100 x 20mm ± 2mm

Type: Sticker Type

Annexure-XXII

Company Logo    

 Sample for Analysis

Product Name ___________________________________________________________

Batch No._________________________________  Batch Size ____________________

Mfg. Date________________________________  Exp. Date______________________

Sample Qty.______________________________ Stage__________________________

Remark_________________________________________________________________

Sampled by (Sign / Date):
Form No.- SOP/QA-000/F1-00

Specification: printing black

Size: 110 x 80mm ± 2mm

Type: Sticker Type

Annexure-XXIII

Company Logo    

Calibration Status

Name of Equipment/ Instrument_____________________________________________

ID No.__________________________________________________________________

Calibration Done On ______________________________________________________

Calibration Due on ___­­­­­­­­­­­­­­­­­­­­­­­­­­­­­____________________________________________________

Calibration Done by_______________________________________________________

Status (Complies/not complies) _____________________________________________

Checked by (Sign/ Date)___________________________________________________

Form No.- SOP/QA-000/F1-00

Specification: Green Strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XXIV

Company Logo  

 Scrap Label

Material Name __________________________________________Qty.____________

Remark_______________________________________________________________

Checked by (Sign / Date):
Form No.- SOP/QA-000/F1-00

Specification: printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XXIV

 Company Logo  

 Equipment Status

Equipment Name ___________________________________ID No._________________

Product Name _____________________________________Batch No._______________

Stage____________________________________________________________________

Checked By (Sign / Date):
Form No.- SOP/QA-000/F1-00

Specification: Grey strip, printing black

Size: 110 x 80mm ± 2mm

Type: Card Type

Annexure-XXVI

Sampled Slip (Bulk Product Sampling)

 COMPANY LOGO  Quality Control Department

                                                   SAMPLED SLIP                                                          

Item Name :   Entry Date :  
Batch No. :   Batch Qty. :  
Mfg. Date :   Exp. Date :  
Sampled On :   Date of Test :  
Sampled By :    Signature :  

Specification: Yellow colour sheet, printing black

Size: 110 x 80mm ± 2mm

Type: Sticker Type

Annexure-XXVII

Passed Slip (Bulk Product)

Company Logo                                                     Quality Control Department

                                                 RELEASE SLIP

Product Name :      
Batch No. :   Sampling Date :  
Mfg. Date :   Batch Quantity :  
Exp. Date :   Test Comply. Date :  
Lab. Ref. No. :   Accepted Qty. :  
Result :   Rejected Qty. :  
Tested By :                                                                  Signature _______    

Specification: Green colour sheet, printing black

Size: 110 x 80mm ± 2mm

Type: Sticker Type

S. No. Name of Label Format No. Date of Receiving Quantity Received Date of Issuance Quantity Issued Quantity Balanced Issued by Received by Remarks
 

 

 

Specimen Annexure of Quarantine-Under Test Status Label

ph

LEAVE A REPLY

Please enter your comment!
Please enter your name here