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Table 2 Annual resource use and benefit

From: Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer

Itema

Annual cost (U.S. dollars)

Minimum –Maximum or α/β

Distribution

Cost of investment in quality

1. Cost of trainings

 Cost of training on product development

8206

7620–9792

Triangular

 Cost of attending Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers of diagnostic products, vaccines, finished pharmaceutical products and active pharmaceutical ingredients

6040

3020–9060

Triangular

 Cost of attending local conference on WHO GMP

12

1/12

Gamma

 Cost of internal GMP training

23,116

1/23,116

Gamma

 Cost of PMG-MAN/NAFDAC training

8040

1/8040

Gamma

 Cost of other external trainings (WAHO, WAPMAM, Cepat)

3157

1/3157

Gamma

2. Cost of analyses

   

 Cost of extra analysis in Nigeria

118

1/118

Gamma

 Cost of extra analysis in Abroad

412

1/412

Gamma

3. Engagement of consultants

   

 Cost for calibration, validation of HVAC and qualification

45,226

41,608–52,613

Triangular

4. Staff recruitment

   

 Cost of employing eight staff including GMP trainer

125,000

96,016–112,500

Triangular

5. Financial records

   

 Cost of auditing international supplier

2352

1/2352

Gamma

 Cost of auditing Nigeria supplier

450

1/450

Gamma

6. Preventive maintenance

   

 Maintenance cost (including spares, cost of hiring contractor)

15,285

7642–15,285

Triangular

7. Product development

   

 Cost of product development

14,654

1/14,654

Gamma

 Cost of stability chamber

6551

5459–8734

Triangular

 Design of palatability study

821

586–1172

Triangular

 Palatability and adherence study

4689

1/4689

Gamma

 Honorarium for key staff

352

1/352

Gamma

 Time in analysis

5862

1/5862

Gamma

 Cost of courier services

293

1/293

Gamma

8. Facility upgrades or new buildings/structures

   

 Equipment cost (HVAC, automated compression machine, blistering machine, HPLC, customized flame photometer, etc.)

92,801

83,521–102,081

Triangular

 Cost of new building/upgrade (factory, laboratory)

357,135

321,421–357,135

Triangular

 Cost of power generation

331,658

1/331,658

Gamma

 Cost of change of filter

7642

1/7642

Gamma

 Cost of change to more efficient blistering machine

38,212

1/38,212

Gamma

 Cost of change to more efficient HPLC and Flame photometer

43,671

1/43,671

Gamma

 Total

1,141,753

  

Benefit of Quality Improvement

   

 Revenue from sales of zinc sulfate 20-mg dispersible tablets in 2016

6,500,000

1/6,500,000

Gamma

 Total

6,500,000

  
  1. aAll cost were annuitized or expressed as annual cost