PharmaConsult Egypt


SERVICE PATHWAY





Conceptual Design



Detail design



Supervision of
project



Feasibility studies



PCE-Modules





Conceptual Design





- Room arch drawings .

- Material flow

- Personal flow

- Waste flow

- Classifications

- Pressure cascade

- Lab & microbiology drawings



Detail Design





- Make working drawings according to GMP rules .

- Make schedules for previous drawings .

- Provide a list with contractors

- Technical discharging of all offer submitted .



Production machines





- Make URS list for solid path machines .

- Make URS list for liquid path machines .

- Make URS list for semisolid path machines .

- Provide a list of suppliers .



R&D





- Formulation &manufacturing units

- Method of analysis

- Prosses validation

- CTD file

- Cleaning validation

- Stability studies

- Dissolution profile



Utilities





-Make URS for facilities.

-Provide a list of suppliers.

-Technical discharging of all suppliers.

-Discuss technical offers according to GMP rules.

-Make a anchoring session through the owner's representative.



As built





- Make as built drawings for civil and mechanical works



FAT





- Receive machines from suppliers both inside and outside Egypt FAT.


Marketing





Technical support is provided by The pharma corslet Office through specialists in pharmaceutical marketing and sustainable management of pharmaceutical investment


Lab furniture





- Make URS for lab machine and furniture .

- Provide a list of suppliers.

- Technical discharging of all submitted contractor.

- Discuss technical offers according to GMP rules.



Production accessories





- Make URS for production supplies.

- Provide a list of suppliers.

- Technical discharging of all submitted contractor.

- Discuss technical offers according to GMP rules.



Supervising





Pharma Consulting office assigns a consultant to oversee the implementation of all specialized designs on site and to receive the factory .



Installation





The pharma consult office installs all machines and delivers engineering facilities to them in collaboration with chimcon Egypt Engineering Contracting



SAT





Receipt of machines after installation at the plant and works

(Qualification + Sat Communication & Start Up)



Licensing





Extraction of licenses for both

(Civil Protection , Environment , Industrial Development , Ministry of Health)



Validation &
calibration





- Testing & balancing & commissioning

- Clean room validation

- IQ &QQ for HVAC system

- Temperature mapping studies .

- BMS validation .

- Calibration (ISO 9001) .





pce-eg



info@pce-eg.com | Call us: +20233909479