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
2026GCB5205
Quotation Number
GCB-2026-03-0004
Client Status
Status
Approved
Reason for Non-Approval
| Description | Man-days | Payer | Cost (EGP) |
|---|---|---|---|
| Stage 1 Audit | 2.00 | - | EGP 20,000.00 |
| Stage 2 Audit | 7.00 | - | EGP 70,000.00 |
| Accommodation | - | By Client | EGP 0.00 |
| Travel | - | By Client | EGP 0.00 |
| Transportation | - | By Client | EGP 0.00 |
| Total Initial Certification Cost | EGP 90,000.00 | ||
|
Man-days Calculation
for ISMS audit time calculation, according to ISO 27006-1 No. of Users = 60, Table C.1 = 11 Man-day Factors for adjustment of audit time 15% subtraction for high maturity of the management system in place Total man-day = 11-15% = 9.3 ~ 9.5 Man-day Calculating audit time:- Table D.2 1=3, 2=3, 3=1 So Business complexity = 3+3+1=7 (high) Tabel D.3 1=3, 2=1, 3=2 So IT complexity = 3+1+2=6 (medium) so D.4 Impact of factors on audit time +10% to +50% final total man-day after add 10% = 10.45 ~ 10.5 Man-day _______________________________________________ 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 ISMS = 10.5 – 15% = 8.9 ~ 9 man-day 1st Stage = 9 – 80% = 1.8 ~ 2 2nd stage = 9 -20% = 7.2 ~ 7 SV1 = 9 * (1/3) = 3 SV2 = 9 * (1/3) = 3 Recert = 9 * (2/3) = 6 |
|||
| Description | Man-days | Payer | Cost (EGP) |
|---|---|---|---|
| Audit | 3.00 | - | EGP 30,000.00 |
| Accommodation | - | By Client | EGP 0.00 |
| Travel | - | By Client | EGP 0.00 |
| Transportation | - | By Client | EGP 0.00 |
| Total First Surveillance Visit Cost | EGP 30,000.00 | ||
| Description | Man-days | Payer | Cost (EGP) |
|---|---|---|---|
| Audit | 3.00 | - | EGP 30,000.00 |
| Accommodation | - | By Client | EGP 0.00 |
| Travel | - | By Client | EGP 0.00 |
| Transportation | - | By Client | EGP 0.00 |
| Total Second Surveillance Visit Cost | EGP 30,000.00 | ||
EGP 150,000.00