Case studies

Referencias

Data Integrity

Project scope:    Establishment and development of a Data Integrity assurance policy according to the current expectations.

Project duration: 2015-2016

Project outline:

  • Comprehensive assessment of the initial scenario, data integrity practices with paper-based and electronic records
  • Identification of gaps with respect to the current expectations
  • Risk Analysis of data management processes
  • Definition of a CAPA plan for improving Data Integrity practices and the supporting technology
  • Establishment of a General Policy for Data Integrity, as part of the Quality Management System of the company
  • Company-wide training on Data Integrity
  • Implementation of actions contained in the CAPA plan:
    • Review and assessment of the validation of computerized systems involved
    • Revision of IT the infrastructure and QMS
    • Validation/re-validation of some computerized systems responsible for some data management processes
    • Replacement of systems/instruments/equipment
    • Implementation of hybrid workarounds

Computerised Systems Validation

International Pharmaceutical Company

Project Scope: Implementation of a new ERP system at a corporate level, in several manufacturing sites worldwide, involving replacement of local systems and interfaces.

Project Duration: 2009-2010

Project Outline:

Integration of the TDV Team into the customer project team, providing the necessary GMP knowledge throughout the project development.

Definition of the validation strategy for the original project and subsequent roll-out projects

Involvement from the URS phase, through the design activities, risk management to the last performance qualification phases.

Establishment of deliverables of each stage of the System Life Cycle.

Supervision of supplier development and documentation activities

Interfaces with corporate and local systems: LIMS, Weighing, EDMS and Warehouse Management systems

Full Quality Risk Management of the implementation project

Validation of the data migration

Preparation of validation and qualification protocols, test scripts and reports

Validation thoroughly reviewed during a later FDA inspection

International Pharmaceutical Company

Project Scope: Implementation of electronic Quality Management System to manage CAPA, audit observation, deviations, complaints and change control.

Project Duration: 2010-2011

Project Outline:

Full prospective validation of the project

Revision and improvement of the current quality management processes by the implementation of the new system (as-is and to-be). Alignment with ICH Q10

Assistance from the URS to the validation report

Agreeing quality and documentation standards with the supplier

Supervising system development

Validation / Qualification Protocols, report, test scripts,…

Supervising supplier tasks and documentation:

  • Functional Specifications
  • Design Specifications
  • Pre-qualification testing

Risk assessment and Design Review

Installation Qualification and Operational Qualification (Functional Test)

Performance Qualification

Review and development of system governance SOP’s

New facilities and manufacturing plants

International Pharmaceutical Company in Spain

Project Scope: Construction of a large warehouse for storage of raw materials, intermediates and finished products; development of computerised systems for fully automated management from reception to distribution operations.

Project Duration: 2008-2009

Project Outline:

Regulatory requirements aligned with EU and FDA GMP/GDP. Supporting ES (21 CFR Part 11).

Validation master planning for facilities, equipment, utilities and computerised systems involved to ensure a full, integrated GMP compliance.

Qualification of facilities and utilities including storage areas, HVAC systems, mechanical components

Validation of the warehouse management system throughout its Life Cycle, from URS to Performance Qualification, including interfaces with Weighing, LIMS and ERP systems.

Establishment of documentation standards

Qualification / Validation of the control systems related to mechanical, dynamic components

Development and revision of logistics related quality system processes, documentation and SOPs

International Pharmaceutical Company in Spain

Project Scope: Construction and qualification of a new solid dosage forms for marking products in the EU and US markets

Project Duration: 2004-2005

Project Outline:

Establishment of the Validation Master Plan and Quality Project Plan for the project

Preparation of the User Requirements Specification (URS) for equipment and facilities

GMP review of the proposed design and intended operations

Preparation of process and cleaning validation and qualification protocols  and reports (IQ,OQ, PQ) for equipment and utilities

Supervision and witnessing of supplier qualification activities and documentation

Deviation analysis and CAPA

Training to the local team

Plant later inspected and approved by EU authorities and US FDA.

Joint venture Spanish-Chinese company in Zhejiang province

Project Scope: Construction and qualification of a new API plant in Zhejiang province, China, for manufacturing products

Project Duration: 2007-2008

Project Outline:

Complying with local, European and FDA GMP requirements

TDV involved in the Project Team to provide consultancy for GMP compliance on the new site.

GMP considerations within the design and future operations

Training to the local team on GMP and Validation

Assistance in supplier selection and supervision

Preparation of the User Requirements Specification (URS) for the new site, equipment and utilities

Validation Master Plan (VMP) for the entire project

Risk Management Plan and initial Risk Assessment (ICH Q9)

Requirements and Design in agreement with operational and regulatory requirements

Site Validation Policy and standards applicable to the current project, equipment, utilities and future extensions

Knowledge and documentation practices transferred to customer for future projects

Medical devices

International diagnostics company

Project Scope: Development of software for instruments used as medical devices in diagnostics.

Project Duration: 2009-2010

Project Outline:

Combination of validation activities with software development activities to ensure compliance to 21 CFR 820, ISO 13485.

Establishment of documentation standards: User Requirements Specifications, Design Review, System architecture documentation, User Manuals, implementation guides

Validation and supervision of Life Cycle documentation of the software

Modular and integration testing plans

Application of Risk Management tools throughout the development project

Preparation of User Acceptance Tests

Logistics

International Pharmaceutical company in Spain

Project Scope: Construction of a large warehouse for storage of raw materials, intermediates and finished products; development of computerised systems for fully automated management from reception to distribution operations.

Project Duration: 2008-2009

Project Outline:

Regulatory requirements aligned with EU and FDA GMP/GDP. Supporting ES (21 CFR Part 11).

Validation master planning for facilities, equipment, utilities and computerised systems involved to ensure a full, integrated GMP compliance.

Qualification of facilities and utilities including storage areas, HVAC systems, mechanical components

Validation of the warehouse management system throughout its Life Cycle, from URS to Performance Qualification, including interfaces with Weighing, LIMS and ERP systems.

Establishment of documentation standards

Qualification / Validation of the control systems related to mechanical, dynamic components

Development and revision of logistics related quality system processes, documentation and SOPs

New products life cycle

International Pharmaceutical company

Project Scope: GMP applied to the different stages of development, commercial manufacturing and worldwide marketing of a new drug, including ICH Q8 and Q9 principles, validation and qualification and supporting regulatory inspection by EU and FDA authorities.

Project Duration: 2009-2011

Project Outline:

Compliance of GMP regulations current in EU, US and other PIC/S countries.

Full and continuous Risk Management techniques applied to the Product Life Cycle

Quality-by-design (QbD) approach establishing the appropriate critical process parameters and  control points at the development stages for their later transfer to the manufacturing plant.

Validation master planning for facilities, equipment, utilities and computerised systems involved to ensure a full, integrated GMP compliance for API, bulk drug product and final product.

Process validation of API and final product using the current three-stage approach to process validation. Validation of cleaning processes.

GMP mock inspections for preparing regulatory authorities inspections

On-site support of FDA inspections in the inspected sites.