1. Mahumod Anwer Abdalkader
ID:12090339
Semisolid dosage
Form : suppositories

2. .Equipments used
.GMP
.Examples
.Production steps
.Quality control
.Quality assurance
.Packaging
.Line clearance
.Storage
contents

3. Definition
semi slid dosage form that inserted into
the body cavity like rectum, urethra,
vagina where they melt or soften to
release the drug and produce their local
or systemic effect.
Its mainly used in children ..
Introduction

4. .This dosage form produce in Julphar X.
.It’s for Liquid & Semi Solid Pharmaceutical
Dosage Forms.
In this plant they have capacity to produce
around 60 million suppositories per year.

5. becomix

6. .Melting vessel (to melt the base )
.Storage vessels
.Stainless steel container
.Becomix 250kg ( heater ,mixer and homogenizer )
.Sieves ( used when the API is added to base )
.Sarong ( Filling – 6/9 per sec )
.Unifill Resonva ( Filling – 12 per sec )
Equipments used in
manufacturing

7. sarong

8. Resnova/unifill

9. .Filtered air supplied
.Airlocks for entry
.Separate areas for operations
.Workers must wear clean uniform, masks &
gloves
Gmp in julphar-10

10. .Remove all materials of previous product.
.Complete neat documentation on time.
.All logbooks (equip., area usage record) are
updated.
.The area is under controlled temperature and
controlled humidity .
Cont…

11. .ADOL ( paracetamol 125 mg )
.Clofen ( diclofenac sodium 12.5 mg )
.Laxocody (Bisacody 5-10 mg )
.Laxolyne 10 mg
.Supraproct-S (Cinchocaine
HCl, .Betamethasone Valerate)
.Rothacin (Indomethacin 100 mg)
Examples of products
manufactured in julphar-vi

13. .The equipment and the process area are
suitable for pharmaceutical manufacturing
conforming with the GMP.
.Equipment and the area are cleaned
immediately after the batch process is over.
.Make regular check to Issuance of raw
material and equipment used .

14. .First step is melting the base at 60C.
.Cool down the mixture to 50C.
.Add the API at 50C ( through filter
sieves ).
.Keep the product in becomix for mixing
and homogenizing.
Production steps

15. Melting vessel ( temp .60C)
Becomix 250 kg
Base + API
Finish
product
Filling
plastic or
aluminum
Packaging QA & QC
Checking

16. .Send the product to filling area.
.QC analysis ( Reject / Release ).
.Last station is packaging ( either
plastic or aluminum material ) .
.Then transfer the product to the store.
Cont…

17. .Responsible to follow the procedure and
system compliance
.The procedure will be divided into 2 portions
.A) check to be carried out to assure the
system and processes
.A-1 line clearance check
.Audit checks to be carried out during filling
operation
Quality assurance

18. B)Weight variation check and attribute
characteristics of fill containers
(suppositories) .
.In process check
.Usually done by check the physical
property ( ex. Weight melting point )
of the dosage form during the
manufacturing by taking sample every
1hr.
Cont… Q.A

19. .Physical :
.Description of weight
.Melting time
.Disintegration time
Quality Control

20. Chemical :
.Assay for API
Microbiological :
.Total aerobic bacterial count
.Total fungal count
.Test for pathogen
Cont… Q.C

21. 21
leak test..
Some defect may occur during
manufacturing of suppositories which
are classified into :
1- minor defect
2- major defect
3- Critical defect
Cont…

22. .Each suppositories will be packed in
blister made of aluminum or PVC.
.All the packaging process ( primary and
secondary ) will be according to MPI .
.Some changes can be done in
secondary packaging according to the
MOH of the imported country .
Packaging

23. 23
.Before start packaging we should take the line
clearance to make sure that only one batch is
filled at the time and the other batch or product
not lying in the area .
.Check the product name and batch number on
line clearance with product related document
and ( i.e. .MPI) and the finished bulk label on
the container and make sure all entries are
correct
Line Clearance

24. .After package product will be transfer to quarantine
area with yellow label until the QA and QC take
samples and confirm the efficiency and safety of the
product .
.If the result matchs requirement it will get a green
label ( release) to start shipment, if not it will get red
label and transfer to rejected area .
.Storage condition of suppositories will be from 20- 25
and 60 for humidity
Storage

25. Marketing Store
Packaging
Planning
Production
Weighing
area
Shipment
Filling
QA
QC

26. .Our training experience in julphar.
.Julphar training manual.
References