Your Complete Quality Solution Provider for the Life Science Industry

Transcription

1 Your Complete Quality Solution Provider for the Life Science Industry

2 PQE at-a-glance Our broad services portfolio, extensive experience, effective project management, and exceptional cost effectiveness, have already proven to be a winning combination for global corporations, as well as small and medium sized companies. We are a UNI EN ISO 9001:2000 certified company with global capabilities across the whole product quality life cycle, allowing us to offer services at a very competitive price. Contract Quality Organisation - Complete Quality Solution provider for GCP, GLP, GMP & GDP areas since consultants on board, one of the largest workforces in Europe able to immediately source projects with 20+ consultants. Wide geographical coverage - offices in Italy, Spain, Poland, the Middle East, China, Mexico and Ecuador International references from more than 4000 projects completed World Wide. Experts speaking more than 15 languages. Experience in working on regional/global projects/rollouts for large corporations. Long history of supporting local leaders and small/medium companies in reaching FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA and other local authorities compliance. Robust methodology along with effective knowledge transfer mechanisms. Exceptional cost effectiveness, whilst maintaining highest quality standards. Internal instruments park for equipment & utilities qualification with traceable calibration certificates.

3 Let s meet us, join excellence Since the foundation of PQE, I have strongly believed that our core values, know-how, people and ethics, can make PQE the market leader for sustainable compliance in Europe and beyond. As a matter of fact, we are growing year by year thanks to a full time workforce of dedicated employees, which allows us to enhance our robust and standardised company culture. Our passion for Life Science always exceeds customers expectations and is the reason why we have successfully completed more than 4000 projects in 35 countries, working in 15 different languages. Come and discover that we consistently maintain what we advertise. Gilda D Incerti, CEO PQE / CORE BUSINESS IT Validation European Leader in Independent Computer System Validation and IT Compliance. Qualification & Engineering Your reliable partner for Engineering, Qualification and Commissioning Activities. Compliance Consulting Services for Total Quality Management and Clinical Practices.

4 IT VALIDATION Computer System Validation Computer System Validation has been Pharma Quality Europe s core business since its foundation in We have an unmatched track record of providing our clients with strategy and execution support with their FDA / EMA / WHO / TGA / SFDA /ANVISA / INVIMA and other Local Regulatory Body compliance projects. Our multidisciplinary team, which has extensive years of experience, enables us to support our clients in turnkey validation projects for all types of computerised systems: management information systems, systems from a manufacturing area and applications used in laboratories. Approach: Our Integrated approach allows us to meet the client s validation requirements through a scalable cost effective and fully regulatory compliant delivery model, based on a robust risk analysis. This approach allows us to minimize customer s internal effort and regulatory exposure, providing for a methodology for a robust maintenance model and optimization of day to day IT processes in a regulated environment.

5 IT VALIDATION Assess: Develop: Execute: Depending on the client s requirements, Pharma Quality Europe has a number of comprehensive capabilities and experience in managing complex multisite and global rollout projects, as well as turnkey remediation programs. System Infrastructure Review CSV Approach Review 21 CFR Part 11 Assessments GxP Assessments System Audits Project Audits Vendor Audits Risk Analysis Gap Analysis Prioritization Process Mapping Best Practices for Cost Saving & Quality of CSV 21 CFR Part 11 compliance strategy Data migration strategies Ongoing Adaptation of Risk based CSV Approach to current Regulations CSV Best Practices Documentation Templates Best Practices Procedures (IT SOPs) Turnkey Remediation projects Validation documentation for any type of system including process and laboratory control systems 21 CFR Part 11 inspection readiness projects Support in Data migration execution System Testing (Unit & Integration Tests, UAT) Test Planning, Execution & Documentation Validation Planning Validation Execution Validation Controlling Change Control Program Management Change Management Periodic Reviews Maintaining Validated Status

6 IT VALIDATION Regulated ICT Solutions Regulated ICT Solutions consists of a team of professionals with a background in electronic engineering, software development, system integration and information technology. Thanks to our proven experience in the field of IT solutions, infrastructure qualification and computer systems validation for life science companies, we are able to offer a broad spectrum of services. Assessment of the compliance level of IT processes against international standards and guidelines (eg. GAMP, NIST, ITIL) IT Infrastructure Qualification IT Infrastructure design & implementation project management Design and implementation of secure WANs Selection and evaluation of hardware and software suppliers Management and monitoring of system integrator Design & management of server rooms and networks Housing and hosting services Data archiving and retrieval ERP suitability and gap Analysis Security Standard Assessment

7 QUALIFICATION & ENGINEERING Qualification Our service excellence is achieved through an interdisciplinary teamwork among engineers and technicians, who have a unique integrated knowledge in process engineering, information technology and quality in regulated environments. Due to our complete in house instruments park, we can provide turnkey qualification solutions for process equipment and utilities qualification, based on the latest technologies and regulatory requirements. This allows us to focus on minimizing compliance related risks and costs for our clients. Qualification protocols writing and execution (Installation, Operational and Performance Qualification) Validation Master Plan Commissioning Plan Cleaning Validation Process Validation Media Fill Protocols Calibration services Witnessing of Supplier Testing activities (FAT/SAT support) Inventory of Process Equipment and Utilities Quality Risk Management User Requirement Specifications Technology Transfer Process Analytical Technology (PAT) Support Clean Room Qualification Warehouses & Cold Chambers Temperature Mapping

8 QUALIFICATION & ENGINEERING Quality Engineering Many steps are part of the design of a pharmaceutical facility. In the PQE approach the most important aspect is always the best solution, which involves TIME - COSTS - QUALITY. Our goal is to establish a partnership with our clients in order to create cost and business effective engineering solutions and to ensure that related regulatory requirements (FDA, EMA, WHO, TGA, SFDA, ANVISA, INVIMA ) are met. Due to our focus on Life Science, we always design with the latest standards and with the point of view of the plant s end user. Concept Development Basic & Detail Design Technology Transfer Support Commissioning Support GMP Review Construction Supervision Project Management Visual Factory Programs Procurement Support

9 QUALIFICATION & ENGINEERING Regulated Lab Solutions PQE has multidisciplinary and specialised team including engineers, chemists, biologists, IT experts with high level expertise. Our aim is to support laboratories in the food and drugs fields, with independent and fully specialised services providing accurate and reliable analytical data in a fully regulated environment. Purchasing and project coordination for new laboratories and renovation Process mapping and solutions for a paperless lab Analytical instrument qualification Equipment calibration and maintenance plan Analytical computer system validation LIMS, Chromatography Data Software vendor selection, support and validation Analytical method development and validation Stability studies

10 COMPLIANCE Life Science Quality Clinical Compliance We provide tailored and cost-effective solutions for Total Quality Management, auditing and training in Life Science field for meeting both regulatory requirements and company s business needs. Health Authorities Inspections support & Mock Audits Quality Policies & Manual, Standard Operating Procedures Documentation Management CAPA System Implementation Annual Product Review support Site Compliance Assessment Risk Management US & EU Regulatory Affair services PQE provides flexible solutions in clinical development, from planning to integrated clinical trial reporting, using state-of-the-art GCP compliant standard solutions. Design and validation of Study Specific Clinical Databases Design of Electronic CRF (ecrf) for Remote Data Capture Edit Checks and Online Discrepancy for Fast Resolution of Queries Data Management Plan Data Entry from Paper or Electronic Sources Data Cleaning and Query Management Clinical Trials packages hosting / housing

11 REGULATORY AFFAIRS RA Full Services Provider Starting from the regulatory strategy, going through the documents editing and submission and through the necessary updates and amendments until the dossier closure, PQE supports customers through the whole drug regulatory lifecycle, providing the full range of regulatory activities. Fully electronic submissions for EU / USA and paper submissions for the countries who still require them can be handled in the fastest way, achieving dossiers compliant to the strict and evolving rules of countries all over the world, thanks to the long-time expertise of our consultants. Regulatory Strategy for EU, USA and other countries Dossier gap analysis and review for Drug Products and Drug Substances DMF / ASMF / CEP Dossiers preparation in ectd or NeeS format Preparation of Product Registration Dossiers (Quality part) Country-specific Module 1 Experts Reports, Overviews and Summaries Investigational Medicinal Product Dossiers Variation/Change application Dossiers Reformatting of documents to ectd compliant submissions Drug Listing Support for electronic submission Pharmacovigilance

12 COMPLIANCE Third Party Audit Based on recent developments in pharmaceutical regulations, concerning starting materials and suppliers, qualification has become even more critical from the GxP perspective. Furthermore, EU and FDA regulators have emphasised that Third Party Audits are accepted.by utilising its experience in the Life Science sector, PQE supports manufacturers in performing many kinds of audits, conducted worldwide by our lead auditors that have a minimum of 15 years of field experience. Manufacturers of API, Intermediates and Excipients (APIC certified Auditors) Distributors of API Contract Laboratories (GMP/GLP) Manufacturers of Final Drug Forms Distributors and Logistic Providers (GDP) Software Suppliers (PDA and Tick-it certified Auditors) Contract Manufacturing Organisation Laboratory Testing Clinical & Pre-Clinic Audits Investigational Site Audit Sterilisation Facilities Storage and Distribution Suppliers of Equipment & Utilities Life Science Education PQE offers cost effective practical training courses based on latest industry guidance, regulations and real-life experience. All courses are full of examples, case studies, and are held by our top class executive consultants. Courses can be organised both at fundamental and advanced levels based on the following topics: Computer System Validation (GAMP, 21 CFR Part 11, IT infrastructure) FDA Inspection Readiness Quality Management System Process Equipment Qualification Laboratory Equipment Qualification Process Validation Analytical Methods Validation Regulatory Affairs Risk Management GCP Compliance and Clinical Trials Process Analytical Technology Technology Transfer Pharmacovigilance

13 We support you globally thinking locally HEADQUARTERS Località Prulli, n 103/C Reggello (FI) Italy Tel Fax info@pqe.eu Offices and Representatives Europe Latin America Middle East Asia