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ICTQ company takes over complete supervision over the project from the beginning of the providing/review conceptual design, basic design, detailed design 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. painful.
ICTQ Pharm Services
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 equipments.
- 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.
ICTQ Pharm is concerned in the first place with the factories producing biological, pharmaceutical, cosmetics and healthcare products, followed by food industry, chemicals and fertilizers where ICTQ Pharm provides integrated quality systems that include:
- Providing a site master file and a products ‘s
- Provide organizational structure for the factory and personal files (job description and documented training records).
- Provide a fully controlled and monitored documentation system for all the technical documents and standard operational methods with the possibility of providing full records for the system and a full training on them.
- Provide a documented system supported by protocols to evaluate performance and calibration for all services and systems and factory production equipment with periodic tests and training on it.
- Provide a documented corrective action and preventive action system (CAPA).
- Provide a documented system for change control system and training on it.
- Provide a documented system for internal audits on quality systems and its techniques and provide training on it.
- Provide a documented system for quality risk management determination and control by using different techniques, for example: Failure Mode Effect Analysis (FMEA) and Hazard Analysis Critical Control Point (HACCP).
- Provide validation protocols for all production processes, cleaning processes, washing and sterilization processes and personal qualifications validation in sterile areas.
- Provide a complete documented program for vendor qualifications and training on it.
- Provide vendor qualification from ICTQ Pharm as a third party and provide audit reports.
- Provide a documented system for storage systems, distribution and cold chain management.
- Provide a documented system for measuring customers’ satisfaction.
- Provide a full documented training program for the technical team.
- Provide a full program for safety and bio-safety and provide training on it.
Provide a complete infection control program and training on it.
Preparation of registration files for pharmaceutical products and cosmetics whether it was a new product or pre-registered, or requiring change in product or pricing and introducing it to the donor legal authorities.
Commitment towards covering all observations and comments from the donor legal authorities.
Commitment towards providing all updated regulating laws from the donor legal authorities.
Services For Quality Control Labs
Provide documented programs for all environmental, microbiological and physical measurements on all systems. For example: water treatment systems and air conditioning system and provide training on it.
Stability studies program (real time and accelerated).
Full operational programs for HPLC.
Provide full documentation systems for laboratories starting from standard operation procedures and log books and records to test methods validation
ICTQ Pharm provides a very special service for all institutions whether they provide service or product and aim to the following ISO certificates:
- • ISO 9001 / 2015 for quality management
- • ISO 14001 / 2015, Environmental management systems.
- • ISO 45001 / 2018, Occupational Health and Safety.
- • ISO 22000 Food Safety Management System which provides risk assessment and Hazard Analysis Critical Control Points (HACCP).
- • ISO for labs 17025 for the year 2015
Training programs for fresh graduates wishing to work in the field of pharmaceutical industries:
- • Recognizing principles of the basic pharmaceutical industries.
- • fundamentals and basics for Good Manufacturing Practice (GMP)
– Training programs at advanced levels in fields requiring Good Manufacturing Practice (GMP) appliance:
– Training programs for quality control laboratories at all chemical, physical and microbiological measurements.
– Training programs in pharmacovigilance (Pharmaceutical Vigilance).
– Training programs for quality control systems ISO 9001 for the year 2019.
– Training programs for industrial, occupational, environmental, security safety and bio-safety systems.
-Training program for infection control in medical institutions as hospitals and laboratories.
ICTQ Pharm provide high quality and verified service to our customers. Full commitment to develop continuous monitoring system to measure our customers’ satisfaction towards each service.
ICTQ Pharm set a timeframe for each service provided and setting measurement and monitoring systems for it. Everyone is responsible for the quality management in ICTQ Pharm to maintain high levels to satisfy the customer. Continuously applying internal revision systems to take all correcting and preventive procedures. Full and continuouscommitment to constantly improve quality systems within the company.