Services
Innovation and technology
consultancy services for the pharmaceutical industry
engineering services for the pharmaceutical industry
C&P Engineering
COMPUTER SISTEM VALIDATION
CSV
DIGITIZATION
QUALIFICATIONS
VALIDATION
HVAC
PHARMACEUTICAL ENGINEERING
KEYS IN HAND
LUMP SUM TURN KEY
EPC
EPCM
PROJECT MANAGEMENT
CONSTRUCTION MANAGEMENT
GENERAL CONTRACTOR
PROCESS ENGINEERING
CLEAN ROOM
CONTROLLED CONTAMINATION
GMP
21 CFR PART 11
ANNEX 11
ANNEX 1
CONTAINMENT
RISK ANALISYS
ADVICE
CONCEPTUAL DESIGN
BASIC DESIGN
DETAIL DESIGN
REVAMPING
CONSTRUCTION
FACILITY MANAGEMENT
WASTE MANAGEMENT
ENERGY MANAGEMENT
MAINTENANCE MANAGEMENT
MAINTENANCE
RISK ASSESSMENT
DATA INTEGRITY
USER REQUIREMENT SPECIFICATIONS
URS
STANDARD OPERATIVE PROCEDURES
SOP
IT INFRASTRUCTURE
SYSTEM INTEGRATION
TRAINING
LIFE SCIENCES
PHARMACEUTICAL
BIOMEDICAL
HEALTH CARE
NUTRACEUTICAL
EQUIPMENT
CLEAN UTILITIES
BLACK UTILITIES
PW
PURIFIED WATER
WFI
WATER FOR INJECTION
CHILLING
CHILLING
QUENCHING AND TEMPERING
SOFTWARE SELECTION
Project specific definition
Functional e Technical Specifications
feasibility study
AUDIT
INSPECTIONS
AIFA
FDA
MHRA
Quality Assurance
ANVISA
Laminar flow hoods.
RABS,Glove Box, Insulators, Switch materials VHP e LAF.
PURE STEAM
PURE STEAM
SPECIAL INSTALLATIONS
GMP REVIEW
AUDIT TRAIL
REMEDATION PLAN
SAP
FAT
SAT
ERP
DCS
SCADA
PLC
HPLC
LIMS
SPECTROPHOTOMETRY
SPECTROSCOPY
Cybersecurity
waste classification
CER CODES
WASTE
engineering services
Services
Innovation and technology
Services
Our strengths
Our strength is our staff, who boast a high level of professionalism, gained both nationally and internationally, with strong knowledge in the areas of:
Design, implementation and qualification of controlled contamination environments.
Validation of IT systems and digitisation of processes.
Waste management and energy optimisation of utilities serving industrial production activities.
Pharma & Process engineering
Pharmaceutical and process engineering in the chemical-pharmaceutical, nutraceutical, medical, cosmetics, electronics, fine mechanics and food sectors
engineering services for the pharmaceutical industry
Pharmaceutical and process engineering in the chemical-pharmaceutical, nutraceutical, medical, cosmetics, electronics, fine mechanics and food sectors.
C&P Engineering’s structure allows it to deal with the various phases of a project, even those of considerable complexity.
This typically engineering activity is made particularly effective by the strong experience in the sector, by the integration with Quality and by the knowledge of production processes: the Customer finds in us an interlocutor who speaks the same language, to define what are “integrated process systems”, i.e. the whole that can be made up of civil components, mechanical, electrical and electro-instrumental plants, in which process equipment necessary for the company’s production activities is integrated. Following the preliminary assessment, the feasibility study and the basic design, our PMs draw up the executive project, which includes a DETAILED definition of the various categories of works (civil,
mechanical, electrical) required to implement the intervention.
- Management consulting
- Preliminary Project Assessment and Feasibility Study CONCEPTUAL DESIGN
- Development of User Requirements (URS) and definition of project specifications (Functional and Technical Specifications)
- Basic and Detailed Design (also with design by cost mode)
- Assistance in the definition phase of new machine and plant investments
- Project management, construction management and site assistance
- Pre- and post-inspection GMP adjustments
Construction
Realisation and revamping of pharmaceutical, medical, nutraceutical and cosmetic production departments.
Realisation and revamping of pharmaceutical, medical, nutraceutical and cosmetic production departments.
C&P proposes itself as a partner for the phases that identify a turn-key path of realization. In this phase all the activities necessary for the realisation of the work are carried out: from the contracting of suppliers, up to the commissioning, according to the client’s needs, through the Project Management and the site assistance for the coordination of the workforce involved in the construction. All this while keeping time, costs, quality and administrative and documentary requirements under control.
- Clean rooms and confined areas
- Particle control and biological containment environments
- Laminar flow hoods
- RABS, Glove Boxes, Isolators, VHP and LAF material passes
- Water and thermal installations
- Air treatment installations (HVAC)
- Electrical installations
- Suction and abatement systems
- Water treatment plants for special use: PW, WFI, PS
- Technological gas production and distribution plants
- Other special installations
- Functional structures or buildings for the construction of Production Plants
- Pharmaceutical infrastructures (false ceilings, cladding, walls)
Qualification, CSV, DQ&I
Documented verification according to the Qualification and Validation process and development of digitisation of processes.
Documented verification according to the Qualification and Validation process and development of digitisation of processes.
C&P Engineering carries out all the typical activities of the Qualification area with internal staff and expert collaborators. The consolidated experience and the wide base of references guarantee the ability to orientate the documentation to the Client’s needs in full compliance with the GMPs (EU and FDA).
- Technical definition and execution of qualification/validation protocols DQ, IQ, OQ and PQ
- Validation Master Plan
- Commissioning activities, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
- HVAC and Utilities (PW, WFI, PS), Process Equipment Qualification & Thermal Mapping
- Execution of calibration programmes
- Quality Risk Management, GMP Reviews, Risk Analysis and definition of adaptation plans
- Drafting of supporting standard operating procedures (SOPs), work instructions and guidelines
C&P operates in the CSV sector and, more generally, in the management of electronic data of computer systems (Data Integrity), providing specific and innovative solutions to companies operating in regulated environments, thanks to a team of professionals with international level experience.
- SW Validation (Management Systems, Production Control Systems andLaboratory Systems)
- Compliance Assessment & Remediation Plan
- Data Integrity Solutions
- Assessment & Qualification of IT Infrastructures
- IT Quality System Development:
- SOPs writing
- Quality Agreement definition
- Audit Trail Review strategy
- Customize Validation Strategy
- IT Audit
- Training
Sector expertise, proactivity, collaboration and attention to needs for a clear vision of future goals and for the provision of an adequate service through personalised support.
- Digital Journey
- Goal of trasformation
- Planning of activities and target definition
- KPI definition
- Digital Consultancy Service
- Data Management
- URS definition and Software Solution
- Automatic Monitoring and Control
- Digital Support
- Application Maintenance: Corrective, Adaptive, Perfective
- Cloud Strategy Selection
- Cybersecurity
- Digital ImplementationTechnologies
- Business Intelligence & Big Data Analytics (BI)
- Internet Of Things (IOT)
- Artificial Intelligence (AI)
- Virtual Reality (VR)
- Augmented Reality (AR)
engineering services for the pharmaceutical industry
Energy, Waste & Maintenance
Managing needs and costs related to maintenance, waste and energy management for companies that usually have other business objectives and are therefore not sufficiently equipped in this field.
Waste management has undergone a major evolution that has forced a change in the approach that companies must take to it. It is not enough to manage waste “safely”, because sometimes this does not include optimising the supply chain and assessing the best collection and disposal methods.
On these points it is necessary to work carefully and competently, in the collective interest (environment) and that of the individual Customer.
C&P Engineering has the necessary experience to be able to guarantee, working in close contact with the Client, a reduction in costs and an optimisation of the available resources.
- Revision of waste classification (EWC CODES)
- Evaluation of management methods
- Separate collection organization
- Disposal optimisation
- Wastewater disposal studies
In the world of telecommunications, the technical and contractual aspects influence each other, contributing to guarantee a benefit or not to the Customer. In such an articulated context that often involves various company services, the primary objective of C&P Engineering is to examine the impact that new technologies/services may have, analysing requirements in the field of mobile and fixed telephony and data transmission. With the appropriate integration of this information it is possible to obtain the best configuration and the best cost, fully satisfying the Customer’s needs.
- Cost positioning analysis
- Research of the best market options
- Assistance with tenders and contracts
- Monitoring of consumption and costs
- Simulation of cogeneration effects on costs
- Evaluation of connection methods
Traditionally, energy is considered as a cost, a bill to be paid and an expense to be kept under control. C&P Engineering wanted to develop an integrated perspective on energy, which allows us to assist the Customer in the delicate phase of energy optimisation of its activities. This allows the Client to capitalise on the real value of energy as a “raw material” and as a resource that can be used to grow and sustain their business in the future.
- Energy audits
- Study of customised solutions
- Study of cogeneration plants
- Implementation of eco-friendly systems
The maintenance area is linked to all those services not directly related to the production process, but indirectly necessary for the activity to take place. Their optimisation therefore brings benefits in terms of both costs and management and, thanks to its experience in the sector, C&P Engineering is able to make an optimal choice of essential services, guaranteeing personalised and tailor-made solutions according to the needs and the problems encountered by the Customer.
- Definition of maintenance programmes
- External management of programmes
- Optimisation of maintenance activities
- Contract definition assistance
- Support in drafting and revising Work Instructions