SERVICES

Pharma Engineering & Qualification

DESIGN AND ASSISTANCE TO CLEAN ROOM AND INTEGRATED PROCESS SYSTEMS

C&P Engineering company structure allows to deal with all the design phases, also highly complex ones.

This engineering activity is particularly effective thanks to the strong experience in this field along with Quality and productive process knowledge: customers find us as a counterpart that speaks the same language to define what “integrated process systems” are.
I.P.S. are all the civil components, mechanical/electric/electroinstrumental plants where process equipment are integrated in order to make companies produce.


  Preliminary project evaluation and feasibility study

  Assistance during definition of new investments for equipment and plants

  Definition of project specification (Technical Specification)

  GMP reviews

  User Requirements (URS) development

  Design according to qualitative needs and available budget (Design by Cost)

  Conceptual Design

  Basic & Executive Design

  Construction Management (Project management and assistance on building site)

  Building of pharma, medical device, nutraceutical and cosmetic units

  Revamping of pharma and API production units

  GMP adaptation before and after inspections

  Productive integration in existing locations

  Custom systems for process phases

PRODUCTION AND TECHNICAL/ORGANISATIONAL CONSULTATION

C&P Engineering was born on a professional project, mixing highly experienced managers coming from leader pharma companies.
This experience allows to follow high level consultation projects on the optimisation of productive structure

Productive re-organization •
Productivity Analysis •
Organisation Redesign •
Productive costs evaluation •
Flow Optimisation •
Feasibility studies •
CAPA System Implementation •

QUALIFICATION AND VALIDATION ACTIVITIES (CSV - IOPQ)

C&P Engineering performs all the typical activities of qualification area thanks to internal personnel as well as experienced collaborators. A solid experience and a wide reference basis allows the capability to write documents according to customer needs, with respect to GMP (EU e FDA).

  Technical definition and qualification/validation execution protocol (Installation, Operational and Performance Qualification)

  Validation Master Plan

  Process Equipment Qualification

  HVAC system Qualification

  Commissioning activities, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)

  Calibration and setting programs execution

  Risk Analysis and Quality Risk Management (RA and QRM)

  Equipment and plants qualification execution (HVAC, PW, WFI, PS)

  Computer System Validation according to GMP and/or GAMP (CSV)

  GMP Reviews, gap analysis and adaptation plans definition

  Writing of Standard Operative procedures (SOP)

  Temperature mapping

  IOPQ basic analytic instruments

COMPUTER SYSTEM VALIDATION

C&P is able to offer an high level of services in the CSV world, focusing the target on the Data Integrity topic, delivering customized and innovative solutions to pharma and medical device companies, provided by a dedicated team with international expertise.

Data Integrity Assessment (ALCOA verification) •

US 21 CFR P11 & EU GMP Annex 11 Compliance Verification  •

Remediation Plan issuing and execution  •

Strategic identification of migration/solving actions for gaps fixing  •

Validation packages writing and execution for Laboratory, Production and Management Information Systems  •

Data Migration verification  •

Best practice of validation execution and maintenance  •

SOPs writing and reviewing  •

Best solutions of Audit Trail Review procedures  •

Periodic Review execution  •

MAINTENANCE MANAGEMENT

Our experience results in Know How on maintenance management systems and on the features making this activity more efficient and compliant to general/sector normative standards. 

  Maintenance program definition
  External management of programs
  Maintenance activities optimisation
  Contract definition assistance
  Support in Work Instructions writing and review

C&P Engineering s.r.l

Via Dei Pratoni, 16/5 Int E
50018 Scandicci (FI), Italy
P. IVA 05504100487
Cap. sociale € 100.000,00 int. vers.

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