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STATUS LABELING

PharmaGuide Hub
November 4, 2023
  1. OBJECTIVE:

To lay down a Procedure for Status Labeling.

  • SCOPE:

This SOP is applicable for Status Labeling during various Operations of Production, QC, QA, Warehouse & Engineering at {Company Name} {Company Location}.

  • RESPONSIBILITY:

Production, Warehouse, QA, Engineering and QC Officer / Executive.

  • ACCOUNTABILITY:

      Head of all departments.

  • PROCEDURE:

Status Labeling is a stage where different types of Labels are affixed at various stages of Operations on In Process Containers, Samples, Areas, and Equipments / Instruments. Different Color code is given to various Labels for proper identification.

  • “QUARANTINE” LABEL:
  • ‘QUARANTINE’ Label shall be affixed on the received Raw and Packaging Material in Warehouse by Warehouse person.
  • Specification of Label shall be 86.0 mm (L) X 56.0 mm (H).
  • Quarantine Label shall contain White Color background with text in Black.
  • Specimen of ‘QUARANTINE’ Label is as shown in Annexure-I.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
QUARANTINE 11 Font Capital & Bold
MATERIAL NAME9 Font Capital & Bold
ITEM CODE9 Font Capital & Bold
GRN NO.                     9 Font Capital & Bold
DATE9 Font Capital & Bold
VENDOR BATCH NO.9 Font Capital & Bold
MANUFACTURING DATE9 Font Capital & Bold
EXPIRY DATE9 Font Capital & Bold
TOTAL QTY.9 Font Capital & Bold
DATE OF RECEIPT9 Font Capital & Bold
CONTAINER NO.                                  9 Font Capital & Bold
MANUFACTURER9 Font Capital & Bold
SUPPLIER9 Font Capital & Bold
PREPARED BY (SIGN. / DATE) 9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “UNDER TEST” LABEL:
  • After sampling from the consignment QC Officer shall sample and affix ‘UNDER TEST’ Labelon the ‘QUARANTINE LABEL’, by overlapping the part where ‘QUARANTINE’ word is written.
  • Specification of the Label shall be 81.0 mm (L) X 56.0 mm (H).
  • Under Test Label shall contain Yellow Color background with text in Black.
  • Label shall contain the following details:
CONTENT OF LABEL                                          FONT SIZE & LETTER STYLE  
{COMPANY NAME}11 Font Capital & Bold
UNDER TEST11 Font Capital & Bold
ITEM9 Font Capital & Bold
B. NO.9 Font Capital & Bold
DT. RECPT.9 Font Capital & Bold
QTY.9 Font Capital & Bold
MFG. DT.                    9 Font Capital & Bold
EXP. DT.9 Font Capital & Bold
MFD. BY.9 Font Capital & Bold
SUPP. BY9 Font Capital & Bold
AR NO.9 Font Capital & Bold
SMPL. DT.9 Font Capital & Bold
REF.NO.9 Font Capital & Bold
SAMPLED BY9 Font Capital & Bold
SAMPLE DRAWN BY9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • Specimen of ‘UNDER TEST’ Label is as shown in Annexure-II.
  • “Q.C.APPROVED” LABEL:
  • ‘Q.C. APPROVED’ Label shall be affixed on theRaw and Packaging Material approved by QC, by overlapping the Under Test Label.
  • Specification of the Label shall be 86.0 mm (L) X 56.0 mm (H).
  • Approved Label shall contain Green Color Background with text in Black Color.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
Q.C. APPROVED11 Font Capital & Bold
ITEM NAME9 Font Capital & Bold
BATCH NO.9 Font Capital & Bold
MFG.DT.9 Font Capital & Bold
EXP. DT.9 Font Capital & Bold
QTY. RECVD.9 Font Capital & Bold
A.R.NO.9 Font Capital & Bold
LOD9 Font Capital & Bold
ASSAY9 Font Capital & Bold
RELEASE DATE9 Font Capital & Bold
RE TESTING DATE 9 Font Capital & Bold
RELEASED BY9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • Specimen of ‘Q.C.APPROVED’ Label is as shown in Annexure-III.
  • “REJECTED” LABEL:
  • ‘REJECTED’ Label shall be affixed on theRaw and Packaging Material Rejected by QC.
  • Specification of the Label shall be 89.0 mm (L) X 56.0 mm (H).
  • Rejected Label shall contain Red Color background with text in Black Color.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
REJECTED11 Font Capital & Bold
ITEM9 Font Capital & Bold
B. NO.9 Font Capital & Bold
MFG. DT.9 Font Capital & Bold
EXP. DT.9 Font Capital & Bold
QTY.9 Font Capital & Bold
NO. OF PKG.9 Font Capital & Bold
MFD. BY9 Font Capital & Bold
SUPP. BY9 Font Capital & Bold
A.R. NO.9 Font Capital & Bold
DATE9 Font Capital & Bold
STORE I/C9 Font Capital & Bold
Q.A. OFFICER9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • Specimen of ‘REJECTED’ Label is as shown in Annexure-IV.
  • “NON-RECOVERABLES” LABEL:
  • NON-RECOVERABLES’ Status Label shall be affixed on the container which contain materials generated during Manufacturing and Packing activities and cannot be reuse. For Example: Broken & Sealing Rejected Container/Jar after filling & sealing operation, Broken Jar/Container (After Filled Jar/Container Inspection), Rejection generated during Semi-finished / Packing stage etc.
  • Non-Recoverables Label shall contain White Color background and text in Black Color.
  • Non-Recoverables Status Label shall be filled by Production Executive / Officer and cross verified by QA Executive / Officer and shall be signed along with Date.
  • Specification of the Label shall be 86.0 mm (L) × 56.0 mm (H).
  • Label shall contain the following details:
CONTENT OF LABEL                                              FONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
NON-RECOVERABLES11 Font Capital & Bold
PRODUCT NAME9 Font Capital & Bold
BATCH NO.       9 Font Capital & Bold
BATCH SIZE      9 Font Capital & Bold
MFG. DATE       9 Font Capital & Bold
EXP. DATE9 Font Capital & Bold
QUANTITY 9 Font Capital & Bold
CHECKED BY & DATE (PRODUCTION EXEC./ OFFICER)9 Font Capital & Bold
VERIFIED BY & DATE (QA EXEC. / OFFICER)9 Font Capital & Bold
FORMAT NO.10 Normal & Capital
  • Specimen of ‘NON-RECOVERABLES’ Label is as shown in Annexure-V.
  •  “TO BE CLEANED” LABEL:
  • ‘TO BE CLEANED’ Label shall be affixed on the IP Containers, Equipments, Utensils, Machines and areas which are to be cleaned.

To be Cleaned Label shall contain White Color background with text in Black Color.

  • To Be Cleaned Status Label shall be filled by Operator and verified by Production Executive / Officer, and shall be signed along with Date.
  • Specification of the Label to Be Cleanedshall be 86.0 mm (L) × 56.0 mm (H).
  • Label shall contain the following details:
CONTENT OF LABEL                                          FONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
TO BE CLEANED 11 Font Capital & Bold
PREVIOUS PRODUCT9 Font Capital & Bold
BATCH NO.       9 Font Capital & Bold
DATE       9 Font Capital & Bold
CHECKED BY (OPERATOR)9 Font Capital & Bold
VERIFIED BY (PRODUCTION EXEC. / OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • Specimen of ‘TO BE CLEANED’ Label is as shown in Annexure-VI.
  • “INPROCESS STATUS” LABEL:
  • ‘INPROCESS STATUS’ Label shall be affixed on the Containers / Equipment which contains Semi- Finished or Finished Materials during operations.
  • In process Status Label shall contain White Color backgroundwith textin Black Color.
  • In process Status Label shall be filled by Production Executive / Officer and cross verified by QA Executive / Officer and shall be signed along with Date.
  • Specification of the in process Status Label shall be 86.0 mm (L) × 56.0 mm (H).
  • Specimen of ‘INPROCESS STATUS’ Label is as shown in Annexure-VII.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
INPROCESS STATUS11 Font Capita & Bold
PRODUCT NAME9 Font Capital & Bold
BATCH NO.       9 Font Capital & Bold
BATCH SIZE      9 Font Capital & Bold
MFG. DATE9 Font Capital & Bold
EXP. DATE9 Font Capital & Bold
STAGE9 Font Capital & Bold
CHECKED BY & DATE (PRODUCTION EXEC. / OFFICER)9 Font Capital & Bold
VERIFIED BY & DATE (QA EXEC./ OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • STATUS LABEL:
  • ‘STATUS LABEL’ shall be affixed for showing the status of Equipments, IPCs, Machines, Materials Status and Rooms / Areas status etc.
  • Status Label shall contain White Color background with text in Black Color.
  • Specification of Status Label shall be 86.0 mm (L) × 56.0 mm (H).
  • Specimen of ‘STATUS LABEL’ is as shown in Annexure-VIII.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
STATUS LABEL11 Font Capital & Bold
PRODUCT NAME9 Font Capital & Bold
BATCH NO.       9 Font Capital & Bold
BATCH SIZE      9 Font Capital & Bold
MFG. DATE9 Font Capital & Bold
EXP. DATE9 Font Capital & Bold
STAGE9 Font Capital & Bold
CHECKED BY & DATE (PRODUCTION EXEC./ OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “CLEANED” LABEL:
  • CLEANED’ Status Label shall be affixed on the Containers, Equipments, Utensils, Machines, IPCs and Areas to indicate status of cleaning.
  • Status Label shall contain White Color background with text in Black Color.
  • Cleaned Label shall be checked by production Executive / Officer and verified by QA Executive / Officer and shall be signed along with Date.
  • Specification of CleanedStatus Label shall be 86.0 mm (L) X 56.0 mm (H).
  • Specimen of ‘CLEANED’ Label is as shown in Annexure-IX.
  • Label shall contain the following details:  
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
CLEANED11 Font Capital & Bold
CONTAINER / ACCESSORIES9 Font Capital & Bold
PREVIOUS PRODUCT9 Font Capital & Bold
BATCH NO.               9 Font Capital & Bold
CLEANED BY              9 Font Capital & Bold
DATE OF CLEANING   9 Font Capital & Bold
USED BEFORE DATE9 Font Capital & Bold
CHECKED BY & DATE (PRODUCTION EXEC./ OFFICER)9 Font Capital & Bold
VERIFIED BY & DATE (QA EXEC./ OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “EQUIPMENT STATUS” LABEL:
  • EQUIPMENT STATUS’ Label shall be affixed on the machine during operation time of the machine to indicate the stage of product.
  • Status Label shall contain White Color background with text in Black Color.
  • Equipment Status Label shall be filled by operator and verified by Production Executive / Officer and shall be signed along with Date.
  • Specification of Equipment Status Label shall be 86.0 mm (L) × 56.0 mm (H).
  • Specimen of ‘EQUIPMENT STATUS’ Label is as shown in Annexure-X.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
EQUIPMENT STATUS11 Font Capital & Bold
EQUIPMENT NAME9 Font Capital & Bold
ID NO.9 Font Capital & Bold
LOCATION9 Font Capital & Bold
PRODUCT NAME9 Font Capital & Bold
BATCH NO.        9 Font Capital & Bold
BATCH SIZE       9 Font Capital & Bold
STAGE   9 Font Capital & Bold
CHECKED BY & DATE (OPERATOR)9 Font Capital & Bold
VERIFIED BY & DATE (PRODUCTION EXEC./ OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “LOOSE BOX” LABEL:
  • ‘LOOSE BOX’ Status Label shall be affixed on the box which contains loose Semi Finished or Finished Materials.
  • Loose Box Label shall contain White Color background with text in Black Color.
  • Specification of Loose Box Label shall be 7.0 mm (L) X 2.5 mm (H).
  • Specimen of ‘LOOSE BOX’ Label is as shown in Annexure-XI.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
LOOSE BOX20 Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “UNDER MAINTENANCE” LABEL:
  • ‘UNDER MAINTENANCE’ Status Label shall be affixed on Machines / Equipments / Instruments which are under maintenance.
  • Under Maintenance Label shall contain White Color background with text in Black Color.
  • Under MaintenanceStatus Label shall be filled by Concerned Department Executive / Officer and affixed on that Machine / Equipment / Instrument which is under maintenance and shall be signed along with Date.
  • Specification of Under Maintenance Label shall be 86.0 mm (L) × 56.0 mm (H).
  • Specimen of ‘UNDER MAINTENANCE’ Label is as shown in Annexure-XII
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
UNDER MAINTENANCE11 Font Capital & Bold
EQUIPMENT / INSTRUMENT/ MACHINE NAME9 Font Capital & Bold
DEPARTMENT9 Font Capital & Bold
DATE9 Font Capital & Bold
OBSERVED  BY (EXEC./ OFFICER)9 Font Capital & Bold
REMARKS9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “EXCESS MATERIAL RETURN” LABEL:
  • ‘EXCESS MATERIAL RETURN’ Status Label shall be affixed on the unused material which is excess after completion of the process (In case of Packaging Material only).
  • Coded material cannot be returned.
  • Excess Material Return Label shall contain White Color background with text in Black Color.
  • Excess Material Return Status Label shall be checked by Production Executive / Officer and verified by QA Executive / Officer and affixed on the excess material to be return to store on Material Return Note Slip /Material Return Note.
  • Specification of Excess Material Return Label shall be 86.0 mm (L) × 56.0 mm (H).
  • Specimen of ‘EXCESS MATERIAL RETURN’ Label is as shown in Annexure-XIII.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
EXCESS MATERIAL RETURN11 Font Capital & Bold
MATERIAL NAME9 Font Capital & Bold
A.R. NO.9 Font Capital & Bold
QTY. RETURNED9 Font Capital & Bold
DATE9 Font Capital & Bold
CHECKED BY (PRODUCTION EXEC. / OFFICER)9 Font Capital & Bold
VERIFIED BY (QA EXEC. / OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “ON-LINE REJECTION” LABEL:
  • ‘ON-LINE REJECTION’ Status Label shall be affixed on the material which is rejected during the Process / Packing Activity.

For Example: labels were rejected during packing process due to improper pasting, any raw material during Process / Shifting.

  • On-Line Rejection Label shall contain Red background with text in Black Color.
  • On-Line Rejection Label shall be checked by Production Executive / Officer and verified by QA Executive / Officer and affixed on On-Line Rejected Material to be return to warehouse on On-Line Rejection Note.
  • Specification of On-Line Rejection Label shall be 86.0 mm (L)×56.0 mm (H).
  • Specimen of ‘ON–LINE REJECTION’ Label is as shown in Annexure-XIV.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
ON-LINE REJECTION11 Font Capital & Bold
MATERIAL NAME9 Font Capital & Bold
A.R. NO.9 Font Capital & Bold
QTY. REJECTED9 Regular &  Bold
PRODUCT & BATCH NO.9 Regular &  Bold
DATE9 Regular &  Bold
CHECKED BY (PRODUCTION EXEC. / OFFICER)9 Regular &  Bold
VERIFIED BY (QA EXEC. / OFFICER)9 Regular &  Bold
FORMAT NO.10 Normal & Capital
  • “HOLD” LABEL:
  • ‘HOLD’ Status Label shall be affixed on the Material (Raw material / Chemical / Reagent / Packaging Material), Semi-Finished / Finished Product which is hold due to some reason for further investigation.
  • Hold Status Label shall contain Red Color background with text in Black Color.
  • Hold Label shall be filled by QA Executive / Officer and shall be signed along with Date with reason for Hold.
  • Specification of the Label shall be 86.0 mm (L) ×56.0 mm (H).
  • Specimen of ‘HOLD’ Label is as shown in Annexure-XV.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
  {COMPANY NAME}11 Font Capital & Bold
HOLD 11 Font Capital & Bold
PRODUCT NAME9 Font Capital & Bold
BATCH NO.9 Font Capital & Bold
BATCH SIZE9 Font Capital & Bold
HOLD QUANTITY9 Font Capital & Bold
STAGE9 Font Capital & Bold
AREA          9 Font Capital & Bold
REASON FOR HOLD           9 Font Capital & Bold
SIGN & DATE (QA EXEC./ OFFICER)9 Font Capital & Bold
FORMAT NO.10 Normal & Capital
  • “DISPENSING SLIP” LABEL:
  • ‘DISPENSING SLIP’ Label shall be affixed on the Dispensed Raw & Packaging Material Containers / Poly Bags in Warehouse by Warehouse Person.
  • Specification of Label shall be 86.0 mm (L) X 56.0 mm (H).
  • ‘DISPENSING SLIP’ shall contain white background with text in Black
  • Specimen of ‘DISPENSING SLIP’ Label is as shown in Annexure-XVI.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
DISPENSING SLIP11 Font Capital & Bold
ITEM9 Font Capital & Bold
ITEM B. NO.9 Font Capital & Bold
REQ. NO.9 Font Capital & Bold
QTY. ISSUED9 Font Capital & Bold
DATE9 Font Capital & Bold
A.R. NO.9 Font Capital & Bold
PRODUCT9 Font Capital & Bold
B. NO.9 Font Capital & Bold
B. SIZE9 Font Capital & Bold
NET WT.9 Font Capital & Bold
TARE WT.9 Font Capital & Bold
GRS WT.9 Font Capital & Bold
WT.BY                                 9 Font Capital & Bold
CHECKED BY9 Font Capital & Bold
VERIFIED BY (QA)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “INPROCESS SAMPLE” LABEL (FOR QA USE ):
  • ‘INPROCESS SAMPLE’ Label shall be affixed on Semi-Finished Sampled material which is for QC testing.
  • In process sample Label shall contain White Color background with text in Black Color.
  • In process sample Label shall be filled by QA Executive / Officer and shall be signed along with Date.
  • Specification of the Label shall be 86.0 mm (L) X 56.0 mm (H).
  • Specimen of ‘INPROCESS SAMPLE’ Label is as shown in Annexure-XVII.
  • Label shall contain following details:
CONTENT OF LABEL                                          FONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
IN PROCESS SAMPLE11 Font Capital & Bold
PRODUCT NAME11 Font Capital & Bold
BATCH NO.       9 Font Capital & Bold
BATCH SIZE      9 Font Capital & Bold
MFG. DATE9 Font Capital & Bold
EXP. DATE9 Font Capital & Bold
QUANTITY9 Font Capital & Bold
SAMPLED BY SIGN/DATE (QA EXEC./OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “UNDER TEST(SEMI-FINISHED)” LABEL (FOR QA USE ):
  • ‘UNDER TEST’ Status Label shall be affixed on In-process testing material which is under testing.
  • Under Test Label shall contain Yellow Color background with text in Black Color.
  • Under Test Label shall be filled by QA Executive / Officer and shall be signed along with Date.
  • Specification of the Label shall be 86.0 mm (L) X 56.0 mm (H).
  • Specimen of ‘UNDER TEST (SEMI-FINISHED)’ Label is as shown in Annexure-XVIII.

Note: If for semi-finished stage waiting for release is not required then product status label shall be  affixed at container.

  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
UNDER TEST(SEMI-FINISHED)11 Font Capital & Bold
PRODUCT NAME9 Font Capital & Bold
BATCH NO.       9 Font Capital & Bold
BATCH SIZE      9 Font Capital & Bold
MFG. DATE9 Font Capital & Bold
EXP. DATE9 Font Capital & Bold
QUANTITY9 Font Capital & Bold
SAMPLED BY SIGN/DATE (QA EXEC. / OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • “APPROVED(SEMI-FINISHED)” LABEL (FOR QA USE):
  • ‘APPROVED (SEMI-FINISHED)’ Status Label shall be affixed on the In-process Semi Finished material which is approved by QC.
  • Approved Label shall contain Green Color background with text in Black Color.
  • Approved Label shall be filled by QA Executive / Officer and shall be signed along with Date.
  • Specification of the Label shall be 7.0 mm (L) X 2.5 mm (H).
  • Specimen of ‘APPROVED (SEMI-FINISHED)’ Label is as shown in Annexure-XIX.

Note: If for semi finished stage waiting for release is not required then product status label shall be                affixed at container.

  • Label shall contain the following details:
CONTENT OF LABEL                                          FONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
APPROVED (SEMI-FINISHED)11 Font Capital & Bold
A.R. NO.9 Font Capital & Bold
DATE9 Font Capital & Bold
SIGN  BY  (Q.A. EXEC./ OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold

“REJECTED(SEMI-FINISHED)” LABEL (FOR QA USE):

‘REJECTED (SEMI-FINISHED)’ Status Label shall be affixed on the in process Semi Finished material which is rejected by QA. For Example: Bulk sample fail by QC due to assay problem.

  • Rejected Label shall contain Red Color withtext in Black Color.
  • Rejected Label shall be filled by QA Executive / Officer and shall be signed along with Date.
  • Specification of the Label shall be 7.0 mm (L) X 2.5 mm (H).
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
REJECTED (SEMI-FINISHED)11 Font Capital & Bold
A.R. NO.9 Font Capital & Bold
DATE9 Font Capital & Bold
SIGN BY (Q.A. EXEC./ OFFICER)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • Specimen of ‘REJECTED’ Label is as shown in Annexure-XX.
  •  “SAMPLE FOR ANALYSIS:
  • At the time of In Process and Semi-finished & Packing stage QA officer affix the label of SAMPLE FOR ANALYSIS on the Sample bag in which sample is taking for testing.
  • Specification of the Label shall be 86.0 mm (L) X 56.0 mm (H).
  • Sample for Analysis Label shall be containing White Color background with textin Black Color.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
SAMPLE FOR ANALYSIS11 Font Capital & Bold
PRODUCT NAME9 Font Capital & Bold
BATCH NO.9 Font Capital & Bold
BATCH SIZE9 Font Capital & Bold
MFG. DATE9 Font Capital & Bold
EXP. DATE9 Font Capital & Bold
STAGE9 Font Capital & Bold
SAMPLE QTY.9 Font Capital & Bold
SAMPLED BY (SIGN/DATE) QA EXEC./OFFICER9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • Specimen of ‘SAMPLE FOR ANALYSIS’ Label is as shown in Annexure-XXI.
    • “UNDER RETEST” LABEL:
  • After sampling from the Quarantine Retest Material QC Officer shall sample and affix ‘UNDER RETEST’ Labelon the ‘QUARANTINE RETEST LABEL’, by overlapping the part where ‘QUARANTINE RETEST’ word is written.
  • Specification of the Label shall be 86.0 mm (L) X 56.0 mm (H).
  • Under Retest Label shall be contain White Color background with textin Black Color.
  • Label shall contain the following details:
CONTENT OF LABELFONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
UNDER RETEST11 Font Capital & Bold
MATERIAL NAME9 Font Capital & Bold
GRN NO.9 Font Capital & Bold
A.R. NO.9 Font Capital & Bold
VENDOR BATCH NO.9 Font Capital & Bold
INSPECTION LOT. NO.9 Font Capital & Bold
CONTAINER NO.9 Font Capital & Bold
STORE LOCATION9 Font Capital & Bold
SAMPLED BY (SIGN/DATE)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • Specimen of ‘UNDER RETEST’ Label is as shown in Annexure-XXII.
  • “CALIBRATION STATUS” LABEL:
  • ‘CALIBRATION STATUS’ Status Label shall be affixed on the instruments which are calibrated.
  • Calibrated Label shall contain White Color background with text in Black Color.
  • Calibrated Label shall be filled by Officer / Executive of the respective Department.
  • Specification of the Label shall be 86.0 mm (L) X 56.0 mm (H).
  • Label shall contain the following details:
CONTENT OF LABEL                                       FONT SIZE & LETTER STYLE
{COMPANY NAME}11 Font Capital & Bold
CALIBRATION STATUS11 Font Capital & Bold
INSTRUMENT NAME9 Font Capital & Bold
ID NO.9 Font Capital & Bold
DATE OF CALIBRATION9 Font Capital & Bold
CALIBRATION DUE ON9 Font Capital & Bold
DONE BY (SIGN & DATE)9 Font Capital & Bold
CHECKED BY (SIGN & DATE)9 Font Capital & Bold
FORMAT NO.10 Font Capital & Bold
  • Specimen of ‘CALIBRATED’ Label is as shown in Annexure-XXIII.
  1. REFERENCES:

   Not Applicable

  • ANNEXURES:
ANNEXURE No.TITLE OF ANNEXUREFORMAT No.
Annexure-IQuarantineQA-009/F01-00
Annexure-IIUnder TestQA-009/F02-00
Annexure-IIIQ.C. ApprovedQA-009/F03-00
Annexure-IVRejectedQA-009/F04-00
Annexure-VNon-RecoverablesQA-009/F05-00
Annexure-VITo be CleanedQA-009/F06-00
Annexure-VIIIn process StatusQA-009/F07-00
Annexure-VIIIStatus LabelQA-009/F08-00
Annexure-IXCleanedQA-009/F09-00
Annexure-XEquipment StatusQA-009/F10-00
Annexure-XILoose BoxQA-009/F11-00
Annexure-XIIUnder MaintenanceQA-009/F12-00
Annexure-XIIIExcess Material ReturnQA-009/F13-00
Annexure-XIVOn-Line RejectionQA-009/F14-00
Annexure-XVHoldQA-009/F15-00
Annexure- XVIDispensing SlipQA-009/F16-00
Annexure-XVIIInprocess SampleQA-009/F17-00
Annexure-XVIIIUnder Test (SEMI-FINISHED)QA-009/F18-00
Annexure-XIXApproved (SEMI-FINISHED)QA-009/F19-00
Annexure-XXRejected (SEMI-FINISHED)QA-009/F20-00
Annexure-XXISample For AnalysisQA-009/F21-00
Annexure-XXIIUnder RetestQA-009/F22-00
Annexure-XXIIICalibration StatusQA-009/F23-00

ENCLOSURES: SOP Training Record.

  1. DISTRIBUTION:
Controlled Copy No. 01:Head Quality Assurance
Controlled Copy No. 02:Head Warehouse
Controlled Copy No. 03:Head Quality Control
Controlled Copy No. 04:Head Production
Controlled Copy No. 05:Head Engineering
Master Copy:Quality Assurance Department
  • ABBREVIATIONS:
SOP:Standard Operating Procedure
No.:Number  
Ltd.:Limited
QA:Quality Assurance
IPCs              :In–Process Containers
Exec.          :Executive
 L:Length
 H:Height
 Mfg.:Manufacturing
 Exp.:Expiry
 GRN No.:Goods Receipt Note Number
 A.R. No.:Analytical Report Number
 QC:Quality Control
 G. Wt.:Gross Weight
 ID No.:Identification Number
 Regular:    Running
 Normal:    Unbold

REVISION HISTORY:

             CHANGE HISTORY LOG

Revision No.Details of ChangesReason for ChangeEffective Date
00New SOPNot ApplicableTo be written manual
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