pharmaceutical market and Audits Aspects of Ethiopian Market. Specially focused on Audits requirements.

1. Pharmaceutical Market
And Audits Aspects of
ETHIOPIA
Faisal ASIF

2. COUNTRY PROFILE
• Ethiopia, in the Horn of Africa,
• Capital: Addis Ababa
• Currency: Ethiopian birr
• Area - 1,221,037 Sq km
• Population - 105 million
• Major religion - Christianity
• GDP growth (PPP) - $2,556
• GDP growth % : 2.6%

3. HEALTH STATUS
• Disease profile : HIV and AIDS, Malaria, Diarrheal disease
• 30,000 Health Extension Workers have been trained and
• Total Health expenditure per capita at average exchange rate 15
USD
• Total fertility rate 4.6%.
• Life expectancy at birth 63.6 years.
• The following list is the 2020 impact-level targets for the
Health System Transformation Plan (HSTP):
• Decrease HIV contraction by at least 60% and achieve zero new
infections among children.
• Lessen the number of TB deaths and incidence rate by 35% and
20% respectively.
• Decrease by malaria mortality rate by at least 40%.

4. PHARMACEUTICAL MARKET
• Current pharmaceutical market size: USD 787 Million
• CAGR Growth 14.8% over the forecast period 2012-2018
• Anti Infective, Cardiovascular & Anti diabetic therapeutic
segments present the largest opportunity for growth.
• Local manufacturing companies 13.
• More than 80% market serves by imported product. Only 15-20%
of domestic market serves by local manufacturer.

5. REGULATORY SYSTEM and Opportunity for Orion
• The industry is administered and
controlled by the Ethiopian Food
Medicine & health Care
Administration and Control
Authority (FMHACA) which is
formerly Drug Administration &
Control Authority (DACA).
• FMHACA issues certificates of
Competence to manufacturer,
importers, wholesalers, & Retailers.
• For the product registration in
Ethiopia factory inspection is
mandatory by FMHACA & FMHACA
follow WHO GMP inspection
guidelines. No. of registered brand
1,185.
Opportunity of Orion
• Good Market Size (Around 787 Million)
• Regulatory system is not so
complicated
• Other Bangladeshi companies already
present
• Lack of skills of local manufacturing
companies
• 80% import based
• Deslor (Desloratidine), Exor
(Esomeprazole), Feroven (Iron
Sucrose) these product have good
scope considering the market
disease profile

6. Checklist for audit of Ethiopia
1. Site Master File (SMF)
2. Quality Manual
3. Validation Master Plan (VMP)
4. Organogram (Factory)
5. Health checkup & Eye sight test reports
6. Incineration by third party Records
7. Fire Fighting records
8. HVAC Qualification Record
9. Yearly Training Calendar and its records for both
on Job & GMP
10.GMP/Self-Inspection audit reports
11.Vendor/ Supplier Audit reports
12.Job Description
13.Source approval procedure and its records
14.Write Off & Disposal records of Non-
conforming/Rejected materials & products
15.Analyst validation records
16.ETP operational records
17.RM, PM, Finished products, ETP &
Water sampling & testing records
18.RM, PM, , ETP & Water specifications
19.Method of analysis of RM, PM, , ETP & Water
20.Finished products Manual (specifications &
Method of analysis) with index
21.Calibration Records of balance, equipment’s,
machine etc.
22.Market Complaint, Deviation Management,
Change Control, CAPA, Failure Investigation,
Risk Management & OOS result records with
index
23.Gowning, cleaning & storage records
24.Cleaning Validation, Method Validation (both
RM & Finished products), Process Validation
protocols & reports
25.Environment Monitoring records
26.Working standard & Reference standard records
with index
27.HPLC Column Management records
28.Destruction of samples & Chemicals reports

7. Checklist for audit of Ethiopia
29. Rework/Re-process records
30. Logbook Maintaining records
31. Standardization of volumetric solution records
32. Product Quality Review records
33. Pest Control records with diagram
34. SOP index
35. Reagent Management records with index
36. Machine/Equipment Qualification status records with
index
37. RM & Finished products Method verification records
38. Retention samples records with index
39. Glass apparatus records
40. Finished products Released records
41. Filter Integrity test records
42. Records of market return Goods destruction
43. Preventive maintenance records of machineries
44. Stability studies report of both accelerated and long
term
45. Operational records of water treatment plant, boiler,
chiller & N2 gas
46. Storage condition of RM, PM, intermediate, bulk &
finished products
47. Microbial activities of RM & Finished products
48. Drug Master file of existing & new products
49. Technology transfer records
50. List of finished products, Raw materials & packing
materials
51. Rejected materials records with index
52. Location of materials & Finished Goods
53. Receiving records of materials & Finished Goods
54. Specimen signature list
55. Cleaning system records of all area
56. Material Management (Vin Card) records
57. Trial report records for new products
58. Hold time materials records with index
59. Daily production planning with execution against
forces
60. Die Punch and change parts management (Cleaning &
Storage)

8. CTD format is required for Registration of Medicines in Ethiopian
Food, Medicine and Health Care Administration and Control
Authority (FMHACA) as per Ethiopia Registration Guideline
CTD format:
• Module 1: Administrative and Product Information
• Module 2: Dossier Overall Summary (DOS)
• Module 3: Quality
• Module 4: Non-Clinical Study Reports
• Module 5: Clinical Study Reports
Annex as per Guideline
• Annex I: Application Form for Registration
• Annex II: Certificate of Pharmaceutical Products
• Annex III: Summary of Product Characteristics
• Annex IV: Requirements for Bioequivalence Study
• Annex V: Sample of Actual Product
Appendices as per Guideline
• Appendix1: Product Quality Review Requirement for Well-Established Multi-Source
Products
• Appendix 2: Requirements for Registration of Products Accepted By a Stringent
Regulatory Authority
• Appendix 3: General Recommendation for Conducting and Assessing a Dissolution Profile
• Appendix 4: Requirements for Re-Registration
• Appendix 5: Product Dossier (DOS-PD) Template

9. THANK YOU