Latino America Consultores Innovation & Technology to make your Business Compliant
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1 Latino America Consultores Innovation & Technology to make your Business Compliant Annex 15 & EMA Process Validation Guide Line 1
2 Changes in Requirements The Pharmaceutical Industry has adapted its business model in response to growing industry constraints and the decline of the primary-care focused blockbuster therapy. Principal Key Success Factors of success in this scenario are: Maintaining Quality Optimising Process Cost Management Reducing Time to Market Optimising Supply Chain Regulatory agency are enforcing Process-Knowledge- Based Validation-Frame, to optimize Validation while using state of the art Process Control Methodology and Risk Management 2
3 Previous Enhancement Q8 Q9 Q10 Q11 Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System Development and manufacture of drug substances Annex 11: Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Computerized System Using Risk Based Approach within Integrated QMS and Quality By Design for a general better Process Understanding, enforce modern concept of Business Quality & Risk based driven pharmaceutical product development and Manufacturing 3
4 Annex 15 and EMA Validation Process Guideline EU Directive 2001/83 ANNEX 15 European Commission Health and Consumer Directorate-General (Eudra Lex, the rules governing medicinal products in the European Union, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use) Annex 15: Qualification and Validation...Principle of Qualification and Validation applicable to Facilities, Equipment, Utilities and Process used for manufacture of Medicinal Product... Guideline on process Validation for Finished Products (information and data to be provided in regulatory Submission) EMA European Medicine Agency New Requirements and Guideline for Validation, introducing and re-enforcing Process Understanding, Process Control, Product Quality through RB Approach 4
5 Basic Principles Quality cannot be tested into products; it should be built-in or should be by design (QBD) 5
6 Impact Annex 15 Basic Principles: Control Operation through QUALIFICATION and Validation over PRODUCT & PROCESS LIFECYCLE.. Planned Changes.. For Facilities, Equipment, Utilities & Processes which may effect Product Quality should be documented- Impact Assessment REQUIRED COMPUTERIZED SYSTEM used for the manufacture of medicinal products should be validated according with EU Annex 11 ICH Q8, Q9, Q10, Q11 OR Other system.. Guaranteeing the same level of product quality & security should be used to support validation & qualification.. Data supporting qualification &/or validation studies obtained from external sources needs to be verified (Provider own Validation &/or in place data controls procedures) 6
7 Impact Annex 15 Organizing & Planning Validation Activities: Planned Qualification & Validation Activities, taking into account Equipment, Process & Product Life Cycle ( Processes Impact Components) Approved Validation Procedures & Trained Personnel Precise Responsibility within the involved personnel ( NOT only QA &/or Validation Manager) VMP as a key element of the required Policy/Approach 7
8 Impact Annex 15 Organizing & Planning Validation Activities: VMP has to contain: Validation Policy Organizational Structure of Validation Activity On site Facilities, System, Equipment, Processes summary & validation status Template for verification documents Planning Change Control and Deviation Management policy references Acceptance Criteria References to existing documents Assessment of required resources Validation Strategy (incl. Re-Validation & Re-Qualification) Statement on Materials, support, suppliers qualification level (appropriate) Complex Projects may require separate VMP Quality Risk Management use and QRM improvement life-cycle Policy 8
9 Impact Annex 15 General Documentation Management Knowledge Management Good Document Practice PQMS will define Documents Life Cycle (including Doc. Role & responsibility) Inter-relationship document approach required (e.g.: Traceability matrix. Doc hierarchy) Validation protocols will includes CSA (Cr. System Attrib.) and Acceptance Criteria Harmonization and Alignment between Company Policy & Provider Verification Docs Protocol and Validation report Changes & Deviation and Conclusion have to be formally recorded and supported by scientific analysis and investigation (within Change Control Procedure) Validation Life Cycle: URS, DQ, FAT/SAT, IQ, OQ, PQ 9
10 Impact Annex 15 Process Validation (All Pharmaceutical Dosage Form ref. Current EMA Guideline for Process Validation) N.B.: Life Cycle Approach to link Product & Process Dev Validation of Commercial manufacturing Process & Maintenance of Process State of control for routine production Traditional Approach OR Continuous verification Approach (processes robustness for consistent product quality) Proof of Process Robustness & Prospective Validation PRIOR to product marketing New Product Process Validation should cover all TARGET market strength Technology Transfer, Product Transfer, Product Updates should be documented in Marketing Authorization document (and its variation) Product Validation CQA and CPP to ensure Validation Status and Product Quality trough scientific basis and risk assessment Number of Validation Batches and size of validation Batches can be justified by Risk Assessment and Continuous Monitoring 10
11 Process Validation Impact Annex 15 Facilities, Systems and Equipment used for Process Validation should be validated and test methods should be validated Process Knowledge from Development Studies should be accessible to manufacturing site.. And should be the basis for Validation activities (tech. transf.) Process Validation Batches must be done by Trained production Personnel Supplier should be qualified under Quality Risk management procedures prior Validation Batches (including packaging materials) Design Space Justification Mathematical (Statistical) Models used to confirm a state of control should be available Concurrent Validation ( incomplete validation for exceptional cases) justified in approved VMP and supported by sufficient (& consistent) data (uniformity, and comply defined acceptance criteria) may be acceptable (document should be available to the QP) 11
12 Nr. Of Batches under routine conditions required and based on Risk Management Principles The minimum of three batches could be changed in case of similar product or processes already used and validated into the same site/line Process Validation Protocol using defined CPP & CQA (Documented Product/Process Knowledge) Included into Validation Protocol: Impact Annex 15 Traditional approach to Validation Short Process description CQA summary CCP and limits other justified NON critical attributes list of equipment and calibration status analytical (validated) methods In Process Control Additional testing Sampling plan Evaluating/recording methods Batch release certification process Function & responsibilities Timing 12
13 Quality by Design Approach QbD development allows routine process controls with high degree of Product Quality Assurance Continuous Process Verification used as an alternative to Traditional Process Validation Continuous Process Verification: Impact Annex 15 Continuous Process Verification Science Based Control Strategy CQA, CPP Required Attributes for Incoming Materials Product Realization PAT & Multivariate Statistic In- Process Control On-Process Control At-Process Control 13
14 Impact Annex 15 Hybrid Process For different production STEPS could be used an Hybrid approach. Needs substantial Product & Process Knowledge & Understanding gained form manufacturing experience and Historical data (batch data) Within this condition, Continuous Process Verification could be used to validate changes and ongoing activities even if they were initially validated using traditional approach 14
15 Impact Annex 15 On Going Process Verification Monitoring Product Quality showing life cycle state of control, analyzing process trends Verification change and improvement of Frequency and extension of Process Verification using increased Process Understanding On Going Process Verification Protocols (& Report) also supported by statistical tools (Variation & State of Control) PQR should be supported by On Going Process Verification On Going Process Verification monitoring incremental changes in Product Life Cycle 15
16 Other Impact Impact Annex 15 Verification of Transportation (ref. to Market Authorization) Risk Management required to analyze environmental condition Validation of Packaging for primary packaging, machine setting, Critical Components parameters, etc. Validation of Utilities Quality of Steam, Water, Air, Pure Fluid, Gases, have to follow requirements of equipments level of test may depends by intended use and Risk Assessment Validation of Test Mode Analytical Methods used for qualification, cleaning validation (see Chpt. 6 EU-GMP Guide part 1) for Microbiological Test and sanitizing agent methods have to demonstrate no influence by sample reagents, or external factors Cleaning Validation (see annex 15) Re- Qualification identify appropriate frequency of re-qualification and improvement Change Control IMPORTANT Part of Knowledge Management handled within the QMS using appropriate SOP taking into account Design Space, QRM, Register 16
17 Guideline on Process Validation Specific Impact Continuous Process Verification Hybrid Approach Design Space Verification Scale-Up Post Approval Change Control Standard v/s NON standard methods of Manufacture 17
18 Guideline on Process Validation Continuous Process Verification into line with ICH Q8, Q9, Q10 and the possibility to use Continuous Process Verification in addition to, or instead of, traditional process validation described into the previous guideline has been added and is encouraged. dos NOT introduce new requirements on Med. Products.. But clarify how companies can take ADVANTAGE of the new possibility given when applying enhanced PROCESS UNDERSTANDING, COUPLED WITH Risk Management tools, under an Efficient QUALITY System Process validation as described into ICH Q7 Continuous Process Verification has been introduced to cover an alternative approach to Process Validation based on a CONTINUOUS MONITORING OF MANUFACTURING PERFORMANCES Approach based on Product & Process Development studies Knowledge &/or previous manufacturing experience. Applicable to both traditional & enhanced approach to Pharmaceutical Development 18
19 Guideline on Process Validation Continuous Process Verification Process validation should NOT be viewed as a ONE-OFF event; have to incorporates a Life Cycle Approach, linking all phases of Product life cycle; Guidance on Process Validation Information and data to be Provided in Regulatory Submission (finished dosage form chemical medicinal product Human & Vet.), joint with ICH Q11 recommendation; Applicable also on Biological, with the appropriate approach due to the Bio Substances; Regulatory Submission information; ICH Q8R2 Process Design EMA Guideline for Process Validation Manufacturing Process Validation EU GMP Annex 15 On-Going Process Verification 19
20 Guideline on Process Validation General Consideration Manufacturing Process Should be Validated prior Marketing.. Process Validation should confirm the adequate Control Strategy and the adequate Product Quality.. For all TARGET market strength, for all sites, for all product (to demonstrate the adequate site s control strategy) Continuous Process verification a risk-based real-time approach to verify and demonstrate that a process operate within pre-defined specific parameters (CQAs) and control strategy requirements (CPP); in-line, at-line, on-line, trends, PAT should be influenced by Prior Development & manufactory Knowledge Process understanding gained by manufacturing experience Product / Process Complexity Technology & Process Automation (legacy) process robustness, manufacturing history.. 20
21 Guideline on Process Validation.. Other Consideration Hybrid Approach and Traditional approach have to be described into dossier, and have to be clear where (step) it is used one or the other;.. Design Space.. Traditional approach may requires Design Space verification Continuous Process Verification, allows validity of design space throughout the Product Life Cycle.. Scale Up scaling Up from laboratory though Pilot up to Industrial scale (Normal Operating Range)... Those part must be described into Dossier (3.2.P P.3).. Ranges of Batches Proposed justify that scaling up batches sizes NOT Alters Homogeneity of CQAs 21
22 Guideline on Process Validation.. Post Approval Change Control.. Clear Change Control SOPs to manage Changes Proposed in Production Processes SPECIFIED in Dossier as part of GMP;.. Standard v/s NON Standard Manufacturing Methods for Processes validated under traditional process validation; full production scale data should be provided into the dossier for non- standard product/process; Particular Manufacturer / site taking into account Patient s Risk; Experience with similar Product (nr. Of product authorized, ); Knowledge gained during development; Compliance History 22
23 Instruments and Methodology 23
24 Product Knowledge QbD in Product Development Supporting Product Life Cycle, from latest R&D phases, through process industrialisation to achieve the desired goals Product & Process Support Supports for Formulation, Pilot Phases, Scale Up and Industrialization Process Qualification Technology Transfer Support Regulatory Affairs & Compliance International Regulatory Support Supports in Preparation Dossiers Supports in Preparation of Technical File for Medical Devices Preparation and Implementation of Variation Procedures 24
25 Process Knowledge & Design Innovation, Design & Value Engineering Health care environment operations require a combination of Technology and Innovation, observing Regulatory Requirements, to achieve Compliance and Resource Optimization. Project: URS, Feasibility, Preliminary Budgeting, Conceptual Design, Basic Design, Detailed Design, Design Qualification Construction: Supplier Coordination, GMP Monitoring, Budget Review, FAT & SAT Coordination, Commissioning and Start-Up Supervision Verification: Equipment & Plant Qualification Support, Utilities Qualification Support, Analytical Methods & Equipment Qualification, Information & Data Management System Validation 25
26 Managing Process Data Compliance, Innovation & Data Management The constant updating of information IT tools facilitates Information management, but at the same time imposes the management, control and validation of systems and archives, to ensure the consistency and security of data. ERP, LIMS, DCS, SCADA, WMS, EDMS have to be in Compliance. Feasibility Study & Software & Supplier Selection Solution Providing & System Integration Support Computer System Validation (GAMP 5.0) 21 CFR 11 Compliance GxP Risk Assessment & Remediation Plan Management Support for IT Infrastructure Management & Enhancement, Networks Qualification Legacy System Assessment & Full Plant Remediation Support 26
27 On Going, Improvement & Maintenance Validation & Technical Support - Managing Project in Compliance Balance between Process and Product Knowledge, Rules and Guide Line, State of the Art technology, allows to speed up Validation Process, optimize effort, but in the meantime ensuring regulatory requirements expectation. Training and Updating of Knowledge Support for Process Improvement and Changing, (in Process, in Production, in Quality issues) Gap Analysis, Risk & Impact Assessment Qualification & Validation (VMP, DQ, IQ - OQ - PQ / PV) Analytical Instruments & Equipment s Validation VMP Review and Preparation Remediation Program Support Metrology & Calibration 27
28 The right size partner in Business Project Management & Business Support Trough the International Network, LAC can support each Step of Pharmaceutical Business in the Central and South America Region, acting as a Technological and Knowledge Bridge, in other word: A SOLUTION Provider Process, Product & Business Product & Partner Research Supplier & Partner Audit Regulatory Support Project & Process Improvement Engineering & Procurement Support Commissioning, Qualification, Validation & Process Qualification Remediation & Revamping Support Technology Transfer Support 28
29 Technological Partnership Enabling Technology Trough the International Network, LAC can support each Step of Pharmaceutical Business in the Central and South America Region, acting as a a SOLUTION Provider. Latino America Consultores has built partnership to supports customers in Project for new plant, improvement of existing plants and equipment. Achieve a full qualified vendor list Be able to estimate turn-key investment based on recent, complete and consistent historical supplier s data base Providing integrated and Synergic Supplier Team Harmonizing project approach, project goals, reducing project inefficiencies 29
30 Strategic & Organisation Supporting Business Improvement To be competitive and efficient any Enterprise needs to use the right mix of Market-Needs. Innovation Plans, Research, Production renovation, introduction of new Product &/or New Organization. Analyzing the AS-IS Supporting Research Analyzing Opportunities / Proposing Feasibility Study Developing a Project (for Plant / Organization / Business) Supporting Exploitation Supporting Qualification & Start-Up & Supporting ON-Going 30
31 Many thanks for your attention Leandro Mbarak Gilberto Rossi
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