sop on status label production department

 

1.0 OBJECTIVE
1.1 To describe a procedure for labeling of containers, equipment’s accessories and materials at various stages.
2.0 SCOPE
2.1 This procedure is applicable to give a status label to all equipment’s, material, products etc.
3.0 RESPONSIBILITY
3.1 Concern operator/worker/chemist shall arrange label at various stages.
3.2 Concern officer/Executive shall execute this SOP.
4.0 ACCOUNTABILITY
4.1 Department Head
5.0 PROCEDURE
5.1 All the area, equipment’s and materials shall be identified with appropriate status labels during each stage of process and operation.
5.2 Status Labeling of Equipment’s:
5.2.1 To Be Cleaned Label:
5.2.1.1 All the equipment after completion of the respective operation will be identified with the label as per Format No
5.2.1.2 The description of the ‘To Be Cleaned’ Label is as follows.
5.2.1.2.1 The term ‘Equipment Name’ indicates the Name of the Equipment to which the label is to be affixed.
5.2.1.2.2 The term ‘Equipment No.’ indicates the Equipment Number to which the label is to be affixed.
5.2.1.2.3 The term “Previous Product” indicates the Name of the Product, which was last manufactured in the Equipment.
5.2.1.2.4 The term “Previous Product Batch No.” indicates the Batch No. of the product, which was last manufactured in the Equipment.
5.2.1.2.5 The term ‘Signature’ and ‘Date’ indicates the signature of the respective departmental officer and date on which operation completed.
5.2.2 Cleaned Label:
5.2.2.1 All the equipment after completion of the cleaning will be identified with the label as per Format No.
5.2.2.2 The description of the ‘Cleaned’ Label is as follows:
5.2.2.2.1 The term ‘Equipment Name’ indicates the Name of the Equipment to which the label is to be affixed.
5.2.2.2.2 The term ‘Equipment No.’ indicates the Equipment Number to which the label is to be affixed.
5.2.2.2.3 The term ‘Previous Product’ indicates the Name of the Product, which was last manufactured in the Equipment.
5.2.2.2.4 The term ‘Previous Product Batch No.’ indicates the Batch No. of the product, which was last manufactured in the Equipment.
5.2.2.2.5 The term ‘Cleaned On’ and ‘Cleaned at’ indicates date & time at which the respective equipment is cleaned.
5.2.2.2.6 The term ‘Cleaned By’ indicates the signature of the person who completed the cleaning of equipment and “Checked By” indicates



signature of the person who check the cleaning of equipment.
5.2.2.2.7 Affix yellow colour ‘Cleaned’ label for the batch to batch (Type-A) and affix Green colour ‘Cleaned’ label for

the Product to product change of cleaning completion (Type-B).
5.3 Status Labeling of Area:
5.3.1 Area Status Label:
5.3.1.1 If the Area is under operation it will be identified with the label as per Format No.:
5.3.1.2 The description of the ‘Area Status Label’ is as follows:
5.3.1.2.1 The term ‘Area Name’ indicates the Name of the Area to which the label is to be affixed.
5.3.1.2.2 The term ‘Product Name’ indicates the Name of the Product which is under process.
5.3.1.2.3 The term ‘Batch No.’ indicates the Batch Number of the Product which is under process.
5.3.1.2.4 The term ‘B. Size’ indicates the Batch Size of the Product which is under process.
5.3.1.2.5 The term ‘Mfg. Date’ indicates the Manufacturing Date of the Product and ‘Exp. Date’ indicates the Expiry Date of the Product, which is under process.
5.3.1.2.6 The Term ‘Stage’ indicates the stage of processing of product which is under process.
5.3.1.2.7 The term ‘Sign.’ and ‘Date’ indicates the signature of the Respective departmental officer and date on which he Update the status.
5.3.2 Equipment Status Label:
5.3.2.1 If the equipment is under operation it will be identified with the label as per Format No.:
5.3.2.2 The description of the ‘Equipment Status Label’ is as follows:
5.3.2.2.1 The term ‘Equipment Name’ indicates the Name of the Equipment to which the label is to be affixed.
5.3.2.2.2 The term ‘Equipment No.’ indicates the Number of the Equipment to which the label is to be affixed
5.3.2.2.3 The term ‘Manufacturing Stage’ indicates the stage of manufacturing of product which is under process.
5.3.2.2.4 The term ‘Product Name’ indicates the Name of the Product which is under process.
5.3.2.2.5 The term ‘Batch No.’ indicates the Batch Number of the Product which is under process.
5.3.2.2.6 The term ‘B. Size’ indicates the Batch Size of the Product which is under process.
5.3.2.2.7 The term ‘Mfg. Date’ indicates the Manufacturing Date of the Product and ‘Exp. Date’ indicates the Expiry Date of the Product, which is under process.
5.3.2.2.8 The term ‘Operator Sign.’ and ‘Date’ indicates the signature of the Equipment operator and date on which he operates the equipment.
5.3.3 Under Maintenance Label:
5.3.3.1 If the equipment or instrument is under maintenance due to break down, preventive maintenance etc., the equipment/instruments



will be identified with the label as per Format No.:
5.3.3.2 The description of the ‘Under Maintenance’ Label is as follows:
5.3.3.2.1 The term ‘Instrument/Equipment Name’ indicates the Name of the Instrument/Equipment to which the label is to be affixed.
5.3.3.2.2 The term ‘Instrument/Equipment No.’ indicates the Number of the Instrument/Equipment to which the label is to be affixed.
5.3.3.2.3 The term ‘Date of Breakdown’ indicates the date on which the Equipment is under breakdown.
5.3.3.2.4 The term ‘Sign.’ and ‘Date’ indicates the signature of the respective departmental officer and date on which he has affixed the label.
5.3.4 Rejected Label:
5.3.4.1 Each container of non-conforming finished goods shall affix with ‘Rejected’ Label as per Format No.:
5.3.4.2 The description of the ‘Rejected’ Label is as follows:
5.3.4.2.1 The term ‘Product Name’ indicates the Name of the Product, which is rejected.
5.3.4.2.2 The term ‘Batch No.’ indicates the Batch Number of the Product which is rejected.
5.3.4.2.3 The term ‘B. Size’ indicates the Batch Size of the Product, which is rejected.
5.3.4.2.4 The term ‘Mfg. Date’ indicates the Manufacturing Date of the Product and ‘Exp. Date’ indicates the Expiry Date of the Product, which is rejected.
5.3.4.2.5 The term ‘Quantity Rejected’ indicates the Quantity of the Product, which is rejected.
5.3.4.2.6 The term ‘A.R. No.’ indicates the analytical reference number of the Product/Material, which is rejected.
5.3.4.2.7 The term ‘Stage’ indicates the current stage/ completed stage of the product, which is rejected.
5.3.4.2.8 The term ‘Sign/Date’ indicates the signature and date of respective department head/ designee.
5.3.4.2.9 The term ‘Container No.’ indicates the number of the respective Container/shipper of the product/material, which is rejected.
5.3.5 On-Line Rejection Label:
5.3.5.1 Each container of non-conforming materials/Product collect during processing shall affix with ‘On-Line Rejection’ Label as per Format No.
5.3.5.2 The description of the ‘On-Line Rejection’ label is as follows:
5.3.5.2.1 The term ‘Item Name’ indicates the Name of the Material, which is rejected during processing.
5.3.5.2.2 The term ‘Product Name’ indicates the Name of the Product, which is under process.
5.3.5.2.3 The term ‘Batch No.’ indicates the Batch Number of the Product which is under process.
5.3.5.2.4 The term ‘Quantity Online Rejected’ indicates the Quantity of the item, which is rejected during processing.
5.3.5.2.5 The term ‘Dispensed Material A.R. No.’ indicates the analytical reference number of the Product/Material, which is rejected during processing.
5.3.5.2.6 The term ‘Stage’ indicates the current stage/completed stage of the product processing.
5.3.5.2.7 The term ‘OLRN No.’ indicates the online rejection note number.
5.3.5.2.8 The term ‘Sign/Date’ indicates the signature and date of respective department head/designee.
5.3.6 Status Label :
5.3.6.1 Label shall be affixed with ‘Status Label label as per Format No.: by production on containers of granules blend, compressed tabs.

coated tabs. and bulk solution of liquid containers with relevant details.
5.3.6.2 The description of the ‘Status Label label is as follows:
5.3.6.2.1 The term ‘Product Name’ indicates the Name of the Product, which is under process.
5.3.6.2.2 The term ‘Batch No.’ indicates the Batch Number of the Product which is under process.
5.3.6.2.3 The term ‘B. Size’ indicates the Batch Size of the Product, which is under processing.
5.3.6.2.4 The term ‘Gross Weight (kg)’ indicates the Gross weight of the respective container.
5.3.6.2.5 The term ‘Tare Weight (kg)’ indicates the Tare weight of the respective container.
5.3.6.2.6 The term ‘Net Weight (kg)’ indicates the Net weight of the respective Product, which is under processing.
5.3.6.2.7 The term ‘Lot’ indicates the Lot number of the respective Product, which is under processing.
5.3.6.2.8 The term ‘Container No.’ indicates the number of the respective container of the product, which is under processing.
5.3.6.2.9 The term ‘Sign/Date’ indicates the signature and date of respective departmental officer on which he affixed the label.
6.0 TRAINING
6.1 Trainer – Head of department.
6.2 Trainee – All concern person.
6.3 Period – One hour or as per required.
7.0 DISTRIBUTION
7.1 One set of master copy & controlled copy submitted the quality assurance department.
8.0 ENCLOSURES
8.1 Format No. 1 : To Be Cleaned

8.2 Format No. 2 : Cleaned

8.3 Format No. 3 : Area Status Label

8.4 Format No. 4 : Equipment Status Label
8.5 Format No. 5 : Under Maintenance

8.6 Format No. 6 : Rejected

8.7 Format No. 7 : On-Line Rejection

8.8 Format No. 8 : Status Label

9.0 ABBREVIATIONS
9.1 SOP : Standard Operating Procedure
9.2 HOD : Head of Department
9.3 QA : Quality Assurance



 

TO BE CLEANED
Equipment Name
ID No.
Previous Product
Previous Product Batch No.
Signature/Date
Format No.:

 

CLEANED
Equipment Name
ID No.
Previous Product
Previous Product (B. No.)
Cleaned On			Cleaned at
Cleaned  By			Checked By
If Equipment is not used within 72 Hours from cleaning, RE-CLEAN before use.
Format No.

AREA STATUS LABEL
Area Name:_______________________________________________ Product Name:_____________________________________________                                          Batch No.:___________________ B. Size:_______________________ Mfg. Date:___________________ Exp. Date:_____________________ Stage:___________________________________________________ Sign.:_________________________  Date:_____________________
Format No

EQUIPMENT STATUS LABEL
Equipment Name
Equipment No.
Manufacturing Stage
Product Name
Batch No.			B. Size
Mfg. Date			Exp. Date
Sign. / Date
Format No.:

UNDER MAINTENANCE
Instrument/ Equipment Name
Instrument/Equipment No.
Date of Breakdown
Sign./ Date
Format No.

REJECTED
Product Name
Batch No.				Batch Size
Mfg. Date				Exp. Date
Quantity Rejected
A.R. No.
Stage			Container No.
Sign/Date
Format No

ON-LINE  REJECTION			Container / Pack No.:
Item Name
Product Name
Batch  No.
Quantity Online  Rejected
Dispensed Material A.R. No.
Stage
OLRN No.
Sign/Date
Format No.

 

STATUS LABEL
Product Name
Batch  No.
Batch size
Gross Weight
Tare Weight
Net Weight
Container No.		—–   Of ——-	Lot No.:
Done By /Date
Checked By /Date
Format No.: