What Can MCIC Provide?

CONCEPTUAL ENGINEERING DESIGN

Our long experience in the pharmaceutical industry, and consolidated knowledge in GMP / FDA allows us to conduct a preliminary study (feasibility study) and to define of the requirements of the conceptual engineering project. Including:

•  The engineering documents that define the conceptual scope of the engineering project
•  The type of technology and equipment specifications to be used
•  Drawings including the conceptual description of the proposed factory which describe the materials flow, personnel flow, production lines configuration, warehouses and utilities as well as assigning all GMP requirements required in preliminary phase that in turn help with investment decision

THE DOCUMENTATION OF CONCEPTUAL ENGINEERING DESIGN

• Overall project definition
• Technical Feasibility
• Economic Feasibility
• Risk Analysis
• Indicative time frame with activities, resources, times and milestones
• Preliminary cGMP Design Documentations.
• Cost assessment for whole project ± 25%.

 BASIC ENGINEERING DESIGN
The basic engineering design phase is generally associated with an economic and financial feasibility study: for one or two solutions that emerge as the most suitable in the previous phase, details of the design are given including field studies, especially further System technical details. In the engineering project, details are provided of the unit costs of the materials and of the different construction phases. This process serves to provide a project cost estimate closer to reality and provide more technical detail which identifying the User Requirement Specification more clearly.

 DOCUMENTATION FOR BASIC ENGINEERING DESIGN

• Design bases and criteria (validation and verification of the Conceptual Engineering).
• Definition of the definitive functional requirements.
• Flow Diagrams of Principal and Auxiliary Processes (personnel and materials)
• Definitive designs including calculations (of all the specialties involved in the project)
• Description of the process and philosophy of the definitive Operation and Control
• Definitive Requirements for Complementary Goods and Services
• Definitive major equipment specifications (designed documentation and engineering plans for each system)
• Piping/Flow and instrumentation diagrams
• Implementation Layout
• Specifications of scope of construction by discipline
• Specification sheets for instruments, equipment and inputs
• Detailed layouts
• Control system specifications
• Control system architecture
• Cost assessment for whole project ±15%

 DETAILED ENGINEERING DSIGN
A detailed engineering project is the set of documents generated from the Basic Engineering. These include all the construction details by discipline (Civil, Mechanical, Process, Electric, Telecommunications, Instrumentation and Control, Computer Systems) which must be approved for construction. This process serves to provide closed project cost estimation without deviations more than ±5% in time and cost.

DOCUMENTATION FOR DETAILED ENGINEERING DSIGN
- GMP Documentations
- Enclosures
- Air Conditioning
- Electricity
- Compressed Air, Steam, Hot and Cold Water
- Purified Water
- Extraction
- Waste Treatment
- Special Gases
- Fire Protection Systems
- Safety

 Engineering Quality Management System

• Engineering Mission and Policy
• Engineering Systems (Coding System, Maintenance System, Environmental Monitoring System, Calibration System, Mapping System, Qualification and Validation System, etc.)

 COMPLIANCE AND VALIDATION

•  URS
•  Commissioning plan and protocols

MCIC work with you to develop a customized commissioning plan that outlines the responsibilities of design team, construction team, equipment suppliers, commissioning and Validation agent, and owner

•  Site Master File; preparation and application
•  Validation Plan or Master Plan (VP/VMP)
•  Standard Operating Procedures (SOP)
•  Quality Manual
•  Risk Assessment
•  Equipment Qualification and Validation Protocols (,DQ, IQ, OQ, PQ, PV,CV)
• Facility and Cleanroom validation including design and supply the environmental indicators monitoring systems which related to the production environment and warehouses which includes:
•  Viable and viable particles count
•  Air flow calculations
• Differential pressure measurement between the different adjacent area  Particle Count Tests
•  HEPA filter DOP (dispersed oil particulate) tests
•  HVAC System Qualification and validation tests
•  Laminar Flow Systems Qualification and validation
•  Safety Cabinet qualification
•  Occupational Safety and Health measurements