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