HISTORY AND MILESTONES
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- Deirdre Dorsey
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2 HISTORY AND MILESTONES HISTORY AND MILESTONES DOC S.r.l., Documentation Organization & Consultancy, was established in 1997 by MASCO group C.E.O. Eng. Alberto Borella and Eng. Paolo Curtò who became Managing Director. DOC key personnel are active members of relevant regulatory recognized organizations like PDA, ISPE and FIP.
3 HISTORY AND MILESTONES DOC operates in Italy through offices based in Padua (near Venice) and Settala (Milan). Settala (Milan) Facility Battaglia Terme (Padua) Facility 2011: DOC got from Lloyd s Quality Assurance Register Limited ISO 9001:2008 certification for cgmp compliance and validation consultancy services
4 2014: new DOC headquarter opening in Settala (Milan) including offices, Training and meeting rooms 2015: DOC service portfolio enlargement in the areas of Process Validation, Product Qualification and Analytical Laboratory tests supporting pharmaceutical manufacturing Companies in compliance with the latest international regulatory requirements.
5 OUR MISSION AND VISION To play the role of the System Integrator, acting as Communication Platform & Facilitator between the cgmp Compliance requirements and the final users. The final result is to provide a functional system totally validated. Be recognised as a qualified provider of Validation Services for pharmaceutical companies on a global scale.
6 DOC EXPERIENCE IN EUROPE
7 DOC EXPERIENCE IN THE WORLD
8 AREAS OF EXPERTISE Validation Maintenance System Design Consultancy Training and GMP Consultancy Process and Product Validation System Qualification Full cgmp Compliance Validation package!
9 VALIDATION LIFE CYCLE APPROACH AREAS OF EXPERTISE VALIDATION LIFE CYCLE APPROACH User Requirement Specification System Maintenance Change control and Process Revalidation Instrumentation Recalibration GMP Personnel Training Ongoing Qualification and Validation (Maintenance) Release to Manufacturing Functional Specification Personnel Initial Training & SOPs Product Performance Qualification Enhanced Design Review (EDR) Quality Risk Management (QRM) Design Specification Design Qualification Installation Qualification Operational Qualification FAT/SAT Support Instruments Calibration Sistem Built Regulatory and GMP reference as per International Standards, EMA, US FDA, WHO, PIC/S..
10 SYSTEM AREAS DESIGN OF AND EXPERTISE CONSULTANCY VALIDATION LIFE CYCLE APPROACH Conceptual Design Support and potential vendors evaluation User requirements specification preparation (URS) Functional & design specification revision (FDS) Quality Risk Management (QRM) Design qualification (EDR: Enhanced Design Review) Traceability Matrix Coordination & assistance (witnessing) for the system commissioning activities at supplier factory & at final user site, i.e: - F.A.T. (Factory Acceptance Test) - S.A.T. (Site Acceptance Test)
11 SYSTEM AREAS QUALIFICATION OF EXPERTISE VALIDATION LIFE CYCLE APPROACH Validation Protocols preparation, Site tests execution & validation reports preparation for: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Product Process Validation (PPV) Computerized control system validation as per GAMP 5 and 21 CFR part 11 requirements.
12 SYSTEM QUALIFICATION AREAS OF EXPERTISE CRITICAL UTILITIES VALIDATION LIFE CYCLE APPROACH Production, storage and distribution of: Water for Injection Purified Water Pure steam Process gases (compressed air, nitrogen, etc) HVAC Systems and related controlled classified areas including: Unidirectional Air Flow areas (LAFs) Environmental monitoring systems (EMS) for critical parameters
13 SYSTEM QUALIFICATION MANUFACTURING EQUIPMENT API Bioprocess (API) Solid finished forms Syntesis Reactors Fermentation Units Powder Mixers Filter dryers Static dryers Incubators High Shear Granulators Oscillating Granulators Freeze Dryers RO/UF purification units Fluidized Bed Granulators and Dryers Centrifuges Crystallizers Centrifuges Downstream Units Tableting Machines Coating Machines Capsules filling and sorting Machines Blistering and Secondary Packaging Lines
14 SYSTEM QUALIFICATION MANUFACTURING EQUIPMENT Liquid Finished Forms QC Laboratories and Warehouse Solution preparation and filtration units Sterilization Autoclave Vials and Ampoules washing, depyrogenation and filling line Washing Machines Prefilled Syringes lines Incubators Bags form, fill and seal machines Freeze Dryers (Lyophilizers) Sterilization Units (Autoclaves and Ovens) VHP sterilizers Dry Heat Oven LAF and Bio Safety Cabinet Freezer Dispening Booth Blow fill and seal machines Washing Machines for equipment pieces Cold Rooms and Warehouse Warehouse Cold Rooms
15 PRODUCT AND PROCESS VALIDATION DOC product process validation services can cover the following typologies: Products as: Active Pharmaceutical Ingredients (APIs) Antibiotic drug formulations Controlled drug substances and their precursors Cytotoxic drugs Radiopharmaceutical drugs Manufacturing processes as: Clinical, R&D or small scale pilot batch Stainless steel or Single Use System Long Process campaign High/Low temperature processes High Pressure/Flow
16 PRODUCT AND PROCESS VALIDATION VALIDATION STUDIES PROCESS PRIMARY PACKAGING FINISHED PRODUCT
17 PROCESS VALIDATION In process material qualification studies on Tubes Connections Process equipment material Single Use Technology Qualification and Validation Process Optimization Study Screening, filterability and scale-up studies PROCESS Product and Process Filter Validation Compatibility Extractables and Leachables Adsorption Studies Viability Studies Bacterial Retention Studies
18 PROCESS VALIDATION Extractables and Leachables Studies Toxicological Evaluation and Assessment Cleaning Validation Validation Master Plan Risk Assessment S.O.P. Development and Review Cleaning Validation Protocol and Report Grouping & Bracketing Approach Toxicological Assessment (PDE) PROCESS Sanitizing Efficacy Validation Analytical Method Development, Validation and Transfer Particle Release Testing and Foreign Matters
19 PRODUCT VALIDATION Material Qualification Studies Compatibility Adsorption Studies Extractables and Leachables Studies on Elastomeric closures Containers Glass Containers Plastic PRIMARY PACKAGING Toxicological Evaluation Assessment Container Closure Integrity Test
20 PRODUCT VALIDATION Sterility Test Studies Endotoxin Limit Test (LAL test) Stability Studies Accelerated and Real Stability Photo stability Oxidation Studies AD/Mix Studies FINISHED PRODUCT Antimicrobial Effectiveness Testing Antimicrobial Susceptibility Testing Leachables Studies Analytical Method Development
21 VALIDATION MAINTENANCE Validation maintenance services supplied by DOC include the implementation of the following Support Systems, able to maintain the Validated State : Standard operating procedure (SOP) for: Operation and cleaning Instruments calibration Preventive maintenance Change control & re-validation Process and System re-validation Periodical instruments calibration Preventive maintenance program Change control management
22 TRAINING Equipment and Systems HVAC and controlled environments Pharmaceutical Water and Steam Systems Moist and Dry Heat Sterilization Solution preparation and filtration Validation of Existing Systems GMP General Topics Computerized System Validation Pharmaceutical Validation Principles Methodology and Documentation Validation Life Cycle (From DQ to PQ ) Quality Risk Management Organization of Technical Manuals For GMP systems Processes and Product Aseptic Processing Sterilizing Filter Validation Extractables & Leachables Single Use System Qualification & Validation Primary Packaging Qualification Container Closure Integrity Testing Cleaning Validation Rapid Microbiology
23 TRAINING Delivered by qualified trainers and active members of PDA, ISPE Duration Customized from Half a day to Two days standard modules Available upon request as totally tailored modules Deliverables at DOC site (30 attendees as ideal number for interaction) or at customer site Each Training includes a group/individual final evaluation session Official Attendance Certificate
24 Consultancy CONSULTANCY New Facility Conceptual Design Pharmaceutical Manufacturing Systems Design Review Quality Risk Analysis (as per ICH Q9) FAT/SAT. support Automated System Development, Change Control and Revalidation (SCADA/DCS) GMP Process & System review Existing Facility Audit Validation Master Plan SOP /Documentation Preparation Single Use Systems Design
25 (some) REFERECENCES
26 ITALIAN HEAD QUARTER ADDRESS: Viale delle Industrie, 12bis Settala (Milano) ITALY Tel Fax Web Mail
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