Provides start to end quality consultancy solutions starting from concept to commissioning for pharmaceutical and healthcare projects.
Consultation Services and Managing Quality Systems for Products:
ICTQ Pharm is pioneer and unique company in the field of consultation services. Especially in drug manufacturing and the industry for biological and pharmaceutical products, due to our experience in this field which exceeds 25 years.
The company takes over complete supervision over the project from the beginning of the conceptual design through all stages of designing and execution to the point of delivering, operation and production and this is according to manufacturing process requirement, rules and the regulating quality standards according to the good manufacturing practice (GMP) as well as Ministry of Health (MOH), World Health Organization (WHO), Food and Drug Administration (FDA), European Medicines Agency and other industrial references in this field.
Generally, all sorts of manufacturing projects for cosmetics, healthcare products, food industry and fertilizers are all within our scope of work.
We provide the following services according to the project’s phases:
Phase One (Conceptual Design):
- Provide /Review conceptual designs according to the manufacturing process and quality systems.
- Provide /Review room classification according to its cleanness starting from the sterile areas to the service room.
- Provide /Review air pressure layout.
- Provide /Review production equipments and service utility distribution.
- Provide /Review personal flow.
- Provide /Review raw and secondary materials flow.
- Provide /Review waste flow.
Phase Two (Basic Design):
- Provide integrated studies for primarily risk management & assessment.
- Provide validation master plan for services and project’s utilities and equipment.
- Distribute the service points for manufacturing rooms and service rooms (treated water and its types – industrial, sterile and compressed air – treated industrial drainage – specifications of HVAC systems – Any services related to production equipment or process).
- Provide room data sheet.
- Provide consumptions lists for mechanical and electric plump.
- Provide any international references required for this phase.
Phase Three (Detailed Design):
- Provide consultations for any specifications for service systems, like the water treatment stations, clean steam, HVAC, drainage, compressed air stations and any other services.
- Provide consultations for finishing schedules for the project based on the manufacturing process.
- Provide consultations for vendor or contractor selection and the regarding contracts to bind them to provide documents, certificates and different types of test protocols according to references of quality for the supplied items.
Phase Four (Project Handover):
- Provide a controlled and documentation system.
- Provide a deviation system.
- Provide consultations and follow-ups on the execution on site to guarantee it matches quality system. In addition to attending validation tests for the systems and the production equipment from manufacturing FAT (Factory Acceptance Test), SAT (Site Acceptance Test), IQ (Installation Qualification) and OQ (Operation Qualification).
- Provide consultation during receival from the contractor and revising all receival documents from certificates to test protocols and guarantee safety.
Phase Five (Getting Licenses From Legal Authorities):
- Provide consultations and file preparations for licensing form legal authorities to start production on site especially MOH (Ministry of Health) according to the required regulations and laws.
Phase Six (Operation and Production):
- Provide consultations and full plan set to resume validation(PQ) performance qualification for the experimentation operation of the systems, services and production equipments with the producer and revise all related documents and protocols.
Provide full quality management system with documents and systems required for the factory according to GMP (Good Manufacturing Practice) and provide certified training courses for the production, quality and engineering teams in the factory.