Danadams Pharmaceutical is a Ghanaian pharmaceutical company established in 2005 with over 250 employees. It produces antiretroviral and other pharmaceutical drugs, and was adjudged the top healthcare leader in Ghana in 2010. The company's vision is to create a healthy Africa through innovative, high quality products. This presentation discusses Danadams' manufacturing process for Danmether tablets, an antimalarial drug. The process involves raw material receipt and testing, granulation, compression, quality control testing, packaging and labeling, and storage of finished goods. Danadams is committed to complying with cGMP guidelines to ensure product quality and safety.

1. DANADAMS PHARMACEUTICAL INDUSTRY
LIMITED;
Project: Danmether Tablets 280mg
PRESENTED BY:
GIFTY GYAN
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2. INTRODUCTION
 Danadams was established and commissioned on the 8th
June, 2005.
 original staff strength of 52 but now has over 250
employees.
 Registered fourteen drugs in 2005 and also received
authorization for seven anti-retro- virals.
 Adjudged the number one leader in the health sector in
Ghana by the GIPC IN 2010.
 Only pharmaceutical industry that produces antiretroviral
drugs in Ghana.
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3. INTRODUCTION
VISION
 Building a strong company that will help create a healthy
Africa, where all Africans have an opportunity to make
their main success happen.
MISSION
 Mission is to be the number one leader in quality regional
healthcare in West Africa, with the largest product portfolio
and biggest market share, using good people, innovative
products and world-class facilities to successfully create,
produce and sell all products.
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4. INTRODUCTION
Quality policy
Danadams begins everything with quality – design it
into every product, embed it into every process, and
teach it to every employee, to ensure high quality
healthcare with excellent outputs that meet or exceed
any stringent regulatory requirements and ensure
customer satisfaction.
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5. INTRODUCTION 5
Anti-Retro -virals
 Bivek (Lamivudine /
Zidovudine
 Effavek (efavirenz)
 Lamdek (lamivudine)
 Nevek (nevirapine)
Analgesics
 Anapain (paracetamol)
 Dafenac (Diclofenac)
 Anfen (Ibuprofen)
Antibiotics
 Amoxycillin
 Danciflox (ciprofloxacin)
 Dangyl (metronidazole)
 Deptrin (cotrimoxazole)
Antimalarial
 Camosunate (amodiaquine
/ artesunate)
 Danmether (artemether
/lumefantrine)
 Danoxine (sulfadoxine)
Anthelmintics
 Antel (albendazole)
 Mentel (Mebendazole)
Anti-Diabetic
 Glimperide (amaryl)
 Metformin (glucophage)

6. THE MANUFACTURING PROCESS 6

7. WAREHOUSE
 Receipt of raw materials of Artemether, Lumefantrine and
excipients.
 Quality Control (QC) department informed.
 Raw materials are quarantined.
 Sampling of raw materials by QC for testing.
 If the materials pass they are labelled as approved and then
stored.
 Storage conditions for the raw materials are:
Temperature: 25± 5C and Humidity: 70 ± 5%
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8. CONT.
REQUISITION:
 Dispensing unit acquire a Batch Manufacturing Record.
 A store request and an issue note filled and on this basis materials are
obtained from warehouse.
ISSUANCE
 Issuance is based on principle
 First-In-First-Out (FIFO)
 First-Expiry-First-Out (FEFO)
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9. PRODUCTION
DISPENSING
 Cleaning and preparation of material labels.
 Line clearance given by QA.
 Weighing of API/EXCIPIENT raw materials.
 For Artemether initial sifting occurs at dispensing stage.
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10. Raw Materials 10
Raw Material MAIN FUNCTION Batch Size (kg)
Artemether Anti-malarial 60.00
Lumefantrine Antimalarial 10.00
Microcrystalline cellulose Diluent, DC binder 28.67
Polysorbate Surfactant 0.25
Sodium lauryl Sulphate Surfactant 0.85
Sodium Starch Glycolate Disintegrant 14.00
Magnesium Stearate Lubricant 2.00
Silicon dioxide Anticaking agent, Glidant and tablet
disintegrant
1.00
Povidone Binder 3.24

11. Granulation
Main processes involved in the granulation process include:
 Pre-mixing – Artemether, Lumefantrine, Polysorbate, Sodium lauryl
sulphate, Microcrystalline cellulose, Sodium starch glycolate
 Kneading – Addition of binder
 Shredding – Initial Sieving
 Drying – To reduce moisture content of powder
 Final Sieving
 Blending – Addition of external phase.
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12. Compression 12
Parameters Standards Importance
Appearance Yellow, round biconvex tablet
with DAN debossed on one side
and a break line on the opposite
side.
Description/Identification
Tablet weight 480.0mg Content uniformity
Thickness 3.40m ± 0.2 (3.20 – 3.60) Affect blistering
Hardness NLT 5Kg/m2 Affect disintegration and friability
Disintegration 1min (NMT 15min) Release of drug (Dissolution)
Friability Not more than 1% Withstand stress and for consumer
acceptance

13. QUALITY CONTROL
 Documentation
 Standard test procedures
 Standard operating procedures
 Engages in
 Sampling of raw materials
 Periodic calibration of some equipment
 Test for raw materials and intermediate product
 Analyzing finished products
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14. CONT.
 Finished Product Standard Test Procedures involves test and specification
for Danmether 280mg tablets in terms of
Description
Identification by uv
Average weight
Weight variation
Disintegration time
Friability
Dissolution
Assay
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15. QUALITY ASSURANCE
The Quality Assurance Department of Danadams
pharmaceutical company is in charge of
 Regulatory/cGMP requirement guidelines.
 In process checks: monitoring of activities for cGMP
compliance.
 Documentation systems.
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16. PACKAGING
Primary Packaging :
Primary packaging material is the material which is in direct
contact with the product.
 The forming temperature is 170oC and sealing temperature is
200oC.
 There are 10 tablets in a blister.
 PVC is used for forming and aluminium foil used for sealing.
 Vacuum Leak test of tablet blister packs are done.
 Batch Packing Records are filled
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17. CONT.
FINAL PACKAGING
 QA gives approval for final packaging
 Blister packages are packed into cartons and shippers
 Batch Packaging records are filled and sent to QA
 Goods are finally sent to finish goods after QA approval.
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18. FINISH GOODS
Concerned with:
 Receiving
 Dispatching
Shippers of Danmether are received after:
 QA approval and with appropriate documentation
Storage conditions
 Temperature: Not above 30oC
 Humidity: Not above 75%
 Dispatch goods using FIFO and FEFO principle.
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19. REFERENCES
 Handbook of Pharmaceutical excipients; sixth edition; Edited by Raymond
C. Rowe
 Quality assurance of pharmaceuticals; volume 2; second edition; World
Health Organization.
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20. END OF PRESENTATION
THANK YOU.
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