Company Name
Vitabiotics Egypt for pharmaceutical industries
Contact Person
Dr. Ahmed Abd El AZIZ
aabdelaziz@vitabiotics-egypt.com
Address
Block no.1, 4th industrial zone, New Borg Al-Arab City Alexandria, Egypt
Scope
The provision of manufacturing and packaging of non-sterile pharmaceutical products (solid and liquid dosage forms) and associated quality control testing (microbiological, chemical and physical).
Quotation Date
09 Mar 2026
Application Number
2026GCB1680
Quotation Number
GCB-2026-03-0003
Client Status
Status
Approved
Reason for Non-Approval
| Description | Man-days | Payer | Cost (EGP) |
|---|---|---|---|
| Stage 1 Audit | 4.00 | - | EGP 40,000.00 |
| Stage 2 Audit | 15.50 | - | EGP 155,000.00 |
| Accommodation | - | By Client | EGP 0.00 |
| Travel | - | By Client | EGP 0.00 |
| Transportation | - | By Client | EGP 0.00 |
| Total Initial Certification Cost | EGP 195,000.00 | ||
|
Man-days Calculation
Employees no. 80 According to IAF MD5 QMS = 6 EMS = high risk 9 OHSMS = high risk 9 for adjustment we reduced 15% for 8.V)c. Maturity of management system 6+9+9 = 27 – 15% = 22.95 ~ 23 _____________________________________________________________ According to IAF MD11 X ISO STD which each auditor covered = AB(4), MF(4), MB(3), SSH(3), N(3), IH(2), HG(4) Y no. of MS Std= 4 Z no. of auditors = 7 100((4-1)+(4-1)+(4-1)+(3-1)+(3-1)+(3-1)+(2-1) / 7(4-1) 100*16 / 7*3 = 1600 / 21 = 76.19% According to figure 1 = 15% So final Audit time calculation QMS, EMS, OHSMS = 23 – 15% = 19.5 man-day 1st Stage = 19.5 – 80% = 3.9 ~ 4 2nd stage = 19.5 -20% = 15.6 ~ 15.5 SV1 = 19.5 * (1/3) = 6.5 SV2 = 19.5 * (1/3) = 6.5 Recert = 19.5 * (2/3) = 13 |
|||
| Description | Man-days | Payer | Cost (EGP) |
|---|---|---|---|
| Audit | 6.50 | - | EGP 65,000.00 |
| Accommodation | - | By Client | EGP 0.00 |
| Travel | - | By Client | EGP 0.00 |
| Transportation | - | By Client | EGP 0.00 |
| Total First Surveillance Visit Cost | EGP 65,000.00 | ||
| Description | Man-days | Payer | Cost (EGP) |
|---|---|---|---|
| Audit | 6.50 | - | EGP 65,000.00 |
| Accommodation | - | By Client | EGP 0.00 |
| Travel | - | By Client | EGP 0.00 |
| Transportation | - | By Client | EGP 0.00 |
| Total Second Surveillance Visit Cost | EGP 65,000.00 | ||
EGP 325,000.00