D.D. API PVT. LTD.

F-288, EPIP, RIICO Industrial Area, Sitapura, Jaipur-302022, Rajasthan,

India

STANDARD OPERATING PROCEDURE

Title: Procedure For Product Change Over & Line Clearance
Department: Production Ointment
SOP No.: DD/API/SOP/OT/002 Revision No.:00 Page 1 of 6
Supersedes Effective Date Review Date

NIL

1.0 OBJECTIVE:
To lay down a procedure for product change over & line clearance.
2.0 SCOPE:
This SOP is applicable to all departments that product change over & line clearance for all units of
AAYUKART PVT. LTD., Jaipur (Rajasthan).
3.0 RESPONSIBILITIES:
3.1 Personnel of concerned department shall be responsible to following the batch changeover and line clearance
activity as per SOP.
3.2 IPQC person shall be responsible to check the batch changeover & line clearance activity to be done as per
SOP.
3.3 Department Head or his designee shall be responsible for implementation of SOP.
3.4 Head Quality Assurance shall be responsible for approval & implementation of SOP.
4.0 ACCOUNTABILITY:
4.1 Head - Production
5.0 PROCEDURE:
5.1 DEFINITION:
Product changeover is the changeover of the area and the equipment after processing of one Product
and before starting the processing of another product. This is essential to avoid the contamination of
previous product into the next product to be processed in Manufacturing and Packing sections.

5.2 BATCH TO BATCH CHANGE OVER (A TYPE CLEANING):

Prepared By Checked By Department Approved by

User Department Head or Designee Head Quality Assurance
Name

Signature

Date
F/QA/001-001/01
 D.D. API PVT. LTD.
F-288, EPIP, RIICO Industrial Area, Sitapura, Jaipur-302022, Rajasthan,
India

STANDARD OPERATING PROCEDURE

Title: Procedure For Product Change Over & Line Clearance
Department: Production Ointment
SOP No.: DD/API/SOP/OT/002 Revision No.:00 Page 2 of 6

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5.2.1 Batch to batch changeover is change over from one batch of a product to another batch (next batch) of
the same product in manufacturing, packing section, sampling & dispensing of raw material.
5.2.2 For individual equipment, first ensure that the process of that batch on that particular equipment or
area is complete, and the product is removed or has proceeded further for the next stage.
5.2.3 To ensure that the document of previous batch removed or has proceeded further for the next stage.
5.2.4 Remove the entire residual product of previous batch like syrup, cream, ointment, oil, bottles, labels
and unit box etc. from the equipment and the area.
5.2.5 Remove the status label of the previous batch.
5.2.6 Clean the equipment with the dry clean lint free cloth, nylon brush and use vacuum as per the
requirement.
5.2.7 Clean the accessory of equipment like dust extractors and dehumidifiers in the area as per their
respective SOP’s.
5.2.8 Affix the status label for the next batch.
5.2.9 Inform to IPQC person & Get the line clearance for processing of next batch and record it on the batch
document of the new batch to be processed.
5.2.10 Start the processing of the new batch.
5.2.11 If the equipment & area not use in between A Type cleaning time to 72 hrs, then perform B Type
cleaning for batch to batch change over.

5.3 PRODUCT TO PRODUCT CLEANING (B TYPE CLEANING):

5.3.1 Product to product changeover is the changeover of the area and the equipment after processing of one
Product and before starting the processing of another product. This is essential to avoid the
contamination of previous product into the next product to be processed in Manufacturing, Packing
sections and Warehouse.
5.3.2 STATUS LABELLING FOR AREA & EQUIPMENT:
5.3.2.1 Remove the product label / in process label from the equipment and area.

Prepared By Checked By Department Approved by

User Department Head or Designee Head Quality Assurance
Signature

Date
F/QA/001-001/01
 D.D. API PVT. LTD.
F-288, EPIP, RIICO Industrial Area, Sitapura, Jaipur-302022, Rajasthan,
India

STANDARD OPERATING PROCEDURE

Title: Procedure For Product Change Over & Line Clearance
Department: Production Ointment
SOP No.: DD/API/SOP/OT/002 Revision No.:00 Page 3 of 6

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5.3.2.2 Affix ‘To Be Cleaned’ Label to equipment and to the area.
5.3.2.3 Remove the previous processed product from the area for storage or further processing.
5.3.2.4 Remove the entire residual product like syrup, cream, ointment, oil, bottles, labels and unit box etc.
from the equipment and the area.
5.3.2.5 Clean the equipment and the area as per their respective Standard Cleaning Procedures.
5.3.2.6 The area cleanliness shall be certified by IPQC person by visual inspection of the area.
5.3.2.7 After approval form IPQC, affix ‘Cleaned’ status label to the area & equipment.
5.3.2.8 User Department and IPQC person shall fill the line clearance record as mentioned in respective BMR
after that assembling of the equipment can be started the process.
5.3.2.9 Affix the status label and start the operation.
5.3.2.10 Mentioned the status of the equipment / process in the remarks column of Equipment Log Book.
5.3.2.11 If any equipment is not used within 72 hrs, affixed “To be Cleaned” label and perform B Type
cleaning.

5.4 SHIFT END CLEANING:

5.4.1 Before the end of the shift the machine is to be stopped & ensure the cleaning of the machine &
accessories by wiping with a dry lint-free cloth.
5.4.2 Ensure cleaning of in-process area & disinfectant solution poured in the respective drains.
5.4.3 All the in-process containers will be properly closed & affixed with the “Equipment Status label”
mentioning the status.
5.4.4 The same should be entered in the Equipment log book.
5.5 SHIFT STARTING CLEANING:
5.5.1 At the start of the shift ensure the cleaning of in process equipment, if the batch is continued for more
than one shift.
5.5.2 Take Line Clearance from IPQC person before work start.

Prepared By Checked By Department Approved by

User Department Head or Designee Head Quality Assurance
Signature

Date
F/QA/001-001/01
 D.D. API PVT. LTD.
F-288, EPIP, RIICO Industrial Area, Sitapura, Jaipur-302022, Rajasthan,
India

STANDARD OPERATING PROCEDURE

Title: Procedure For Product Change Over & Line Clearance
Department: Production Ointment
SOP No.: DD/API/SOP/OT/002 Revision No.:00 Page 4 of 6

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5.5.3 If the same product is continued for more than 3 days then B Type cleaning of equipment & area shall
be done as per respective SOP & take line clearance from IPQC person.
5.6 Perform B Type cleaning of the area & equipment after three batches (For Batch to Batch) & after every batch
(For Product to Product).
5.7 Mentioned the type of cleaning as:
5.7.1 Type A - Batch to Batch changeover
5.7.2 Type B - Product to Product changeover.
5.7.3 Type C: Shift end & start cleaning.
5.8 LINE CLEARANCE:
5.8.1 Before commencing any activity, concerned supervisor shall obtain line clearance from IPQC
personnel and get approval of area as stipulated in BMR.
5.8.2 In the event of any deviation from line clearance checks, the IPQC personnel shall bring it to the
notice of concerned Supervisor and get it rectified.
5.8.3 Perform line clearance checks during dispensing, manufacturing, visual inspection and packing as per
following points:
5.8.3.1 Verify the Name and Batch No. of current product as per respective BMR.
5.8.3.2 Materials and traces of previous batch shall be removed from area.
5.8.3.3 Area & equipment cleanliness shall be done as per respective SOP.
5.8.3.4 Cleanliness, calibration of equipment shall be verified.
5.8.3.5 IPQC person shall be check Equipment ID no.
5.8.3.6 Temperature and humidity of area shall be within specified limit.
5.8.3.7 Previous product batch record and status label removed from the area.
5.8.3.8 All raw/packing materials which are to be dispensed are approved by Quality Control.
5.8.3.9 Status label in area and on equipment to be updated as per respective BMR.
5.8.3.10 Batch Record availability of Current Product.
5.8.3.11 QC report of bulk released shall be available before starting the process.

Prepared By Checked By Department Approved by

User Department Head or Designee Head Quality Assurance
Signature

Date
F/QA/001-001/01
 D.D. API PVT. LTD.
F-288, EPIP, RIICO Industrial Area, Sitapura, Jaipur-302022, Rajasthan,
India

STANDARD OPERATING PROCEDURE

Title: Procedure For Product Change Over & Line Clearance
Department: Production Ointment
SOP No.: DD/API/SOP/OT/002 Revision No.:00 Page 5 of 6

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5.8.3.12 Cleanliness of Visual inspection machine.
5.8.3.13 Cleanliness of the collecting trolley.
6.0 ABBREVIATIONS:
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
LTD : Limited
IPQC : In Process Quality Control.
BMR : Batch Manufacturing Record
7.0 REFERENCES:
In house
8.0 ANNEXURES:
NIL
9.0 DISTRIBUTION LIST:

MASTER COPY Quality Assurance (QA)

DEPARTMENT CODE
CONTROLLED COPY Quality Assurance Department QA

Production (Ointment) OT

10.0 REVISION HISTORY:

Sr. No. Change control no. Revision no. Date of revision Reason for revision
01. NA 00 NA New SOP

END OF THE DOCUMENT

Prepared By Checked By Department Approved by

User Department Head or Designee Head Quality Assurance
Signature

Date
F/QA/001-001/01
 D.D. API PVT. LTD.
F-288, EPIP, RIICO Industrial Area, Sitapura, Jaipur-302022, Rajasthan,
India

STANDARD OPERATING PROCEDURE

Title: Procedure For Product Change Over & Line Clearance
Department: Production Ointment
SOP No.: DD/API/SOP/OT/002 Revision No.:00 Page 6 of 6

Prepared By Checked By Department Approved by

User Department Head or Designee Head Quality Assurance
Signature

Date
F/QA/001-001/01