This document discusses changeover clearance, which is a process to ensure an area is free of residue before a new process. It describes minor changeovers between batches of the same product and major changeovers between different products. The types of changeovers and responsible personnel are defined. Key aspects of changeover clearance include cleaning equipment and areas, ensuring correct documentation, and labeling. Changeover clearance helps prevent mix-ups and contamination between products to maintain quality. The document stresses the importance of proper changeover clearance procedures.

1. Presented By:
Md. Shafiqul Islam
Asst. Compliance Manager
ADVANCED CHEMICAL INDUSTRIES LIMITED

2. Changeover Clearance:
What is Changeover?
Line clearance is a process which provides a high
degree of confidence or assurance that the said
line or area is free from any unwanted residue or
left over of previous processing’s before
proceeding for next process. Quality assurance
has to provide Line clearance before the start of
any activity whether it is batch to batch change
over and Product to product change over

3. Changeover Clearance:
Type of Changeover clearance
1. Minor Changeover Clearance
2. Major Changeover Clearance
# Minor Changeover Clearance
(Batch to Batch Changeover Clearance):
Change over from one batch to another batch of
same product and same Strength or increasing in
strength provided the excipients is same.
Cleaning between batches of same product but in
ascending or increasing strength.

4. # Major Changeover Clearance ( Product to product
changeover clearance):
 Change over from one product to another product.
 Change over form one product to same product with
descending or decreasing strength.
 Change over between batches / product with different
Colour/ Flavour / Excipients.
 Change over after post maintenance or when the next
product is not known (as applicable).
 Continuously running of one batch for a longer period
of time.
 Area or Equipment is kept ideal for more period of
time.
Changeover Clearance:

5. Line clearance should be carried out at
change over by Manufacturing,
Packaging, Raw Material Store, Packing
Material Store etc independently for the
stages where final dosage form &
intermediates are formed, handled and
processed.
Changeover Clearance:

6. Changeover Clearance:
Changeover can be divided into the 3 Ups:
1. Clean-up includes removal of previous Product,
Materials and Components from the line, area &
machine.
2. Set-up is the process of actually converting the
equipment.
3. Start-up is the time spent fine tuning the
equipment/machine after it has been restarted.

7. Changeover Clearance:
Key responsible personnel for Changeover Clearance:
1. Cleaner
2. Operator
3. Line In charge
4. Production Officer
5. Compliance Officer
Why Changeover Clearance is so Importance :
1. Reduce the chances of mix-up
2. Prevent Contamination/Cross-Contamination
3. Reduce the chances of batch failure.

8. Changeover Clearance:
Changeover clearance require
1. When go one product to another product in same
area/Machine- Major Changeover
2. When go one batch to another batch of same product-Minor
Changeover
3. When same product continue for long time in same
area/Machine-
Major Changeover
** At every changeover clearance must be carried out through a
approved instruction.

9. Changeover Clearance:
The following factors are very important
during changeover clearance
 Machine , Equipment ,Line clearance, Area
clearance.
 Environment clearance & personal hygiene
 Product clearance.
 Document clearance.
 Ensure proper status labeling.

10. Changeover Clearance:
Machine , Equipments & Line clearance
 Check & ensure the cleanliness as per instruction.
 Ensure the setting of correct change parts.
 Ensure the sterility of change parts where require
 Ensure the swab test clearance of change parts/machine
where require
 Ensure the Machine , Equipments & Line is fit for use
 Ensure calibration all necessary instruments
 Inching before operation

11. Changeover Clearance:
Area clearance
* Ensure sufficient working & storage area.
* Ensure proper room cleanliness & house keeping.
- Floor
- Side Wall
- Window
- Door
- Ceiling
- Light shed
- Proper segregation
- Swab test result (Potent to non potent drug)
* Ensure the removal of previous product :
- materials (All RM & PM components)
- wastage
- documents

12. Changeover Clearance:
Environment Clearance & Personal Hygiene
Ensure the followings :
Room temp. & humidity.
Proper ventilation & Pressure differential
Air pressure , Air flow rate & Air lock system
Proper lighting.
Trained personnel
Particle count & microbial count within limit
Personnel should maintain the followings:
 Must wear cleaned & prescribed garments.
 Hand gloves, mask, beard cover & headgear.
 Strictly prohibited eating, chewing, smoking, unnecessary talking &
movement.
 No person allowed who has open lesion & exposed surface disease.

13. Changeover Clearance:
Product clearance
Input materials : Check should be done before clearance :
* Raw materials – Ensure Correct RM as per Process sheet:
- Name
- Code No.
- QC Ref. No.
- Potency
- Exp. Date
- Released label
- PW test result
- WFI test result
* Bulk product – Ensure correct product through status label
and bulk clearance report from QAD.

14. Changeover Clearance:
Product clearance
Packing material: Ensure correct & cleaned primary and
secondary PM as per BPR.
Primary PM: Bottle, Ampoule, Canister, Vial, Aluminum foil, PVC,
Aluminum tube, Laminated tube, ORS sachet, Plastic container,
Capsule shell, Flip off seal, Tear off seal etc.
Ensure cleanliness & sterility of primary PM where required.
Secondary PM: Carton, Label, Leaflet, Spoon, Dropper,
Disposable Syringe, Security ape ,Cup & Outer etc.

15. Changeover Clearance for PM
Printing
Ensure proper batch coding on labels & cartons
- Batch No.
- Mfg Date
- Exp. Date
- Price

16. Changeover Clearance:
Product Clearance
Output materials : Check should be done before clearance :
* Tablet & Capsule : Size & shape, Appearance, Leak test, Hardness,
Disintegration, Embossing of Batch No. & Expiry date, QC pass label etc.
* Liquid : Volume, Appearance, pH, Cap sealing, Labeling, weight/ml & Screwing,
Unscrewing.
Cream/Ointment : Weight, Embossing of Batch No. & Mfg. Date, Expiry date,
Sealing etc.
* Dry syrup/Sachet : Weight, Batch No. & Mfg. Date, Expiry date, Leak test
Sealing etc.
Ampoule & Vial : Volume, Appearance, Leak test
MDI Product: Weight, QC pass ,Batch No. & Mfg. Date, Expiry date, Leak test
Sealing etc.

17. Changeover Clearance:
Ensure Documents Clearance
- Ensure Correct & approved Process sheet & BPR
- Correct Display board (Batch No. ,Mfg. Date & Exp. Date)
- Calculation where required.
- Ensure correct batch coding approval (Batch No. ,Mfg. Date &
Exp. Date & Price)
* Use different approved form , checklist & Logbook : e g.-
- Use correct Change over checklist
- Use Correct check list for In process inspection
- Use correct Traceability form
- Use correct Process control chart
- Use foil over printing / punching approval form
- Use inspection sheet for leak test of strips & Blisters
- Use screwing and unscrewing check list
- Use room temp. & humidity check list.
-All Necessary Logbooks
**All necessary input must be ensured in BMR/BPR/Logbook/Checklist/Form
during changeover clearance

18. Changeover Clearance:
Ensure Proper Status Labeling
In every containers/drums/storage vessel in which bulk product, partly
packed product, sub batch is stored, Packing materials container & all
machine and equipments should be labeled or marked with an –
 Indication of product identity
 Quantity
 Batch No.
 Status
 Sign & Date
 Any more

19. Changeover Clearance
Special Note for everyone
After compilation of all necessary activities and maintained
proper documentation according to instruction and
checked /accepted by dedicated production/compliance
personnel then operation will be continued.
We must remember that no way to start any kind of
operations without taking changeover clearance !!
Never compromise with quality!

20. Conclusion:
*Without proper changeover clearance we never
prevent product mix-up & product
contamination.
*Proper changeover clearance is very important for
ensuring product quality during dispensing,
manufacturing & packaging operations.
*So, it is our responsibility to ensure proper
changeover clearance and ensure product quality
for safety of the patients.

21. THANK YOU