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  1. 1. Mahumod Anwer Abdalkader ID:12090339 Semisolid dosage Form : suppositories
  2. 2. .Equipments used .GMP .Examples .Production steps .Quality control .Quality assurance .Packaging .Line clearance .Storage contents
  3. 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. 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. 5. becomix
  6. 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. 7. sarong
  8. 8. Resnova/unifill
  9. 9. .Filtered air supplied .Airlocks for entry .Separate areas for operations .Workers must wear clean uniform, masks & gloves Gmp in julphar-10
  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. 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
  12. 12. .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 .
  13. 13. .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
  14. 14. Melting vessel ( temp .60C) Becomix 250 kg Base + API Finish product Filling plastic or aluminum Packaging QA & QC Checking
  15. 15. .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…
  16. 16. .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
  17. 17. 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
  18. 18. .Physical : .Description of weight .Melting time .Disintegration time Quality Control
  19. 19. Chemical : .Assay for API Microbiological : .Total aerobic bacterial count .Total fungal count .Test for pathogen Cont… Q.C
  20. 20. 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…
  21. 21. .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
  22. 22. 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
  23. 23. .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
  24. 24. Marketing Store Packaging Planning Production Weighing area Shipment Filling QA QC
  25. 25. .Our training experience in julphar. .Julphar training manual. References