Engineering & Consulting
- From Idea to Complete Turn-Key Projects.
- CD (concept design)
- Basic Design
- DD (detailed design)
- URS for machines and utilities
- BOQ
- Automation (BMS – EMS)
- Validation
- Qualification (IQ – OQ – DQ)
Performing all Requested Operations, Process Lay-out, Flow of Material and Personnel.
Construction from Building Design Planning, Civil works, Air Conditioning according to Cleanliness Standards Requirements and Installation to Validation using the most Advanced Technology in the Conceptual, Basic and Detailed Designs to the Standards of Current GMP and to apply for the approval of EC and FDA.
- Giving the Optimal Solutions, in line with the Criteria as agreed with the Client.
– Flexible.
– Efficient.
– Low Cost.
– Simple to expand. Submitting the detailed Specifications for the different Construction items which match with the required global Standards.
- Submitting the capacities and Specifications for:
– The different Production equipment.
– The Technical & Engineering Services. - Submitting the Engineering Design for:
– Architectural Design.
– Structural Design.
– Sanitary Design.
– Electrical Design.
– Mechanical Design.
– Communication Design.
– Fire Fighting Design.
– Etc - Project Management for Designing:
– Cost Estimates.
– Time Schedule for design work.
– Follow up and Coordination between different Designers.
– Final Checking of all designing sheets for different engineering activity. - Project Management for Construction and Supervision:
– Confirming the following:
– The execution is according to project design criteria and to the international Standards.
– The execution is matching with the GMP.
Qualifying the Pharmaceutical Plants for FDA, CE, ISO Standards by implementing of QMS (Quality Management System) requirements.
Developing Master Plant Validation Program for concurrent qualification of all Plant equipment’s.
Design Qualification, IQ/OQ/DQ for the whole Production areas, HVAC system and Production Equipment and Laboratory equipment.
Developing statistical evaluation program for the connection of the product quality with the production process and cost evaluation for Cost reduction management..
Experts Group has the ability to provide a Range of Consultancy Services, Depending upon the needs of the Client.
- Short-term and / or Long-term advice on Production and manufacturing.
Problems and providing the support needed.
Technical/Cost Feasibility Studies for new Product manufacturing.
Advice on the specification and supply sources of equipment for the manufacturing and other factory operations.
- Advice on the specification and supply sources of pharmaceutical and cosmetics raw material.
- Advice on product license packages including formulation and chemical & clinical data.
- Analysis of client sales projection and preparation of an overall capacity plan for the proposed facilities.
- Give the advice and support for product development and registration.
- Production process (upstream, downstream, formulation & filling) transfer up to industrial scale.
Analytical methods transfer and suitability.
- Related validation activities (E&L, sterility assurance etc.) and documental activities (SOPs, BRs, RA etc.) support.