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PLANNING OF PHARMACEUTICAL FACTORIES - …

PLANNING OF PHARMACEUTICAL FACTORIES CONCEPT AND IMPLEMENTATION WORLD CLASS PHARMA FACILITY PRESENT SCENARIO : The globalization and open market policies have proved to be a boon for the industries, but also have generated the need for globally acceptable manufacturing facilities. There are many flourishing manufacturing facilities, but not all are in compliance with the various regulatory standards. NEED FOR A FACILITY : Rapid change in manufacturing technology & various regulatory compliances to upgrade for better solution in line with cGMP.

PLANNING OF PHARMACEUTICAL FACTORIES CONCEPT AND IMPLEMENTATION WORLD CLASS PHARMA FACILITY PRESENT SCENARIO : The globalization and open market policies have proved to be a boon for

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Transcription of PLANNING OF PHARMACEUTICAL FACTORIES - …

1 PLANNING OF PHARMACEUTICAL FACTORIES CONCEPT AND IMPLEMENTATION WORLD CLASS PHARMA FACILITY PRESENT SCENARIO : The globalization and open market policies have proved to be a boon for the industries, but also have generated the need for globally acceptable manufacturing facilities. There are many flourishing manufacturing facilities, but not all are in compliance with the various regulatory standards. NEED FOR A FACILITY : Rapid change in manufacturing technology & various regulatory compliances to upgrade for better solution in line with cGMP.

2 With globalization, the need for a compliant facility has become a statutory necessity. PARTICIPANTS TO THE PLANNING PROCESS Forecasts for x years Objectives Budget Company internal approvals Technology Logistics Building services Building technology Approvals ( PHARMACEUTICAL ) Approvals (non- PHARMACEUTICAL ) PLANNING Execution Internal Planner Authorities PLANNING TEAM(S) SCHEDULE EXAMPLE Company standards, PLANNING conditions (quantities, technologies, products, deadlines, budget ..) Specific guidelines, (Biosafety, Fed Std, OSHA) for conception, PLANNING , operation.

3 Norms ISO, ATEX, Labour and environmental PHARMACEUTICAL regulations, EU, FDA, PIC/S, WHO, requirements of pharmacy inspectors, product registration .. NORMS, REGULATIONS AND REQUIREMENTS General laws + regulations Process / Equipment GMP and Hygiene Zoning Quantitative data Layout Feasibility Concept Basic Design Detail Design Execution Complete detailing for all disciplines Layouts 1:20, 1:50 Tendering Refining of elements Calculations Functional tendering Layouts 1:100 PLANNING STEPS HOAI Feasibility Concept Basic Design Detail Design Execution Conceptual design Basic Design Detail Design Execution CONVENTIONAL MODEL IMPROVED MODEL PLANNING MODELS FEASIBILITY VERSUS CONCEPTUAL STUDY Static Dominated by Economical Criteria No Project Alternatives.

4 Yes / No only No Influence on Schedule of Subsequent Phases Feasibility Includes the Feasibility Study Dynamic / prospective Dominated by Technical Criteria Project Alternatives are generated User oriented Choices possible - Costs - Technology - Organisation Reduces Time spent on subsequent Phases, while increasing their Precision Conceptual Study Strong Conceptual design Basic Design Detail Design Execution PLANNING MODELS It pays to invest into a strong conceptual design Low initial costs Early clarification of main issues Powerful decision tool Possibility to develop alternatives Freewheeling PLANNING SEQUENCE AND ITERATION PROBLEMS PLANNING Task Start Task Definition Targets Requirements Analysis Conceptional Design with Alternatives Basic Design Execution easy

5 Difficult Detail Design 100% 90% 80% 60% 50% 40% 30% 20% 10% 70% 100% RELATIVE COSTS OF THE DIFFERENT PHASES The cheapest and most promising Phase is the Conceptual Phase ! Detail Engineering Factory size Factory organisation Technology GMP concept Basic Design Conceptual Design Execution Cost saving potentials 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% POSSIBILITIES OF COST MINIMISATION Basic Design The best and cheapest chance to minimise cost of investment and operation is in Phase 1 ! Detail Engineering Execution Costs saving potential Conceptual Design Factory size Factory organization Technology GMP Small teams Brainstorming Alternatives New ideas Feasibility Conceptual design Basic design Detail design Execution Supervision Documentation Cost estimation Cost calculation Tender documents Offers Final quotations The better the concept.

6 The higher the precision DETERMINATION OF COSTS in relation to the PLANNING stage PRICE PAID PRECISION OF COSTS in relation to the PLANNING stage stage 30% Cost estimation Feasibility Conceptual design 5% Final Quotations Execution Supervision Documentation 20% Cost calculation Basic Design 10% Tender documents Offers Detail Design The better the concept, the higher the precision Feasibility Conceptual design Basic design Detail design Execution Supervision Documentation DETERMINATION OF COSTS in relation to the PLANNING system Turnkey price: poor control General planner.

7 Good control - + The Purpose of the Conceptual Design is to arrive to Layout General Factory Organisation Procedures Hygiene Concept Technology Concept Air Handling and Utilities Concepts which can be successfully presented to Authorities for a Pre-Approval Design Review GMP Considerations and Factory PLANNING go Hand in Hand PURPOSE OF CONCEPTUAL DESIGN and to get a high degree of safety about Investments Schedule - PLANNING of a production plant future oriented flexible economical in investments and operating costs GMP conform conform to local / international regulations - High motivation of staff by high quality of working place - Efficient PLANNING - Adequate quality standard (value for money) - Architecture compatible with local surroundings TARGETS OF PHARMACEUTICAL FACTORY PLANNING HOW TO REACH A GOOD CONCEPTUAL DESIGN RESULT ?

8 Right team Good method Discipline Good data Some fantasy Right team Good method Discipline Good data Some fantasy Right team Good method Discipline Good data Some fantasy Right team Good method Discipline Good data Some fantasy Right team Good method Discipline Good data Some fantasy PEOPLE AND PLANNING A Quote: You do not really understand something unless you can explain it to your grandmother." Albert Einstein The idea is to work intensively with a small group of people, possibly detached from their daily chores.

9 These people must have the necessary know-how (or back-ups) and the power of decision CORE TEAM Production Manager Quality Assurance Integrated Factory PLANNING Experts Process GMP Expert Controller AD HOC MEMBERS Utilities Specialist Other Specialists Logistics Engineering PEOPLE AND PLANNING Generalists Specialists Execution Detail Design Conceptual Design Basic Design PLANNING VALIDATION Generalists Specialists Number of people Number of people PEOPLE AND PLANNING 90%

10 100% 80% 70% 60% 50% 40% 30% 20% 10% Individuals Concept Team Large Organisations Judgement Errors Number of Participants Role of participants : To plan AND to decide JUDGEMENT ERRORS By Experimenting and Innovating By Cloning Existing Units By Adding Individual Functions By Turnkey Contracting PLANNING METHODS There are many design methods By Systematic PLANNING Masterplan General organisation factory Site, Site selection Departments Functional groups Equipment, single units PLANNING FROM INSIDE TO OUTSIDE PLANNING FROM MACRO TO MICRO PLANNING FROM IDEAL TO REAL OPTIMAL PLANNING METHOD NEED FOR FOCUSING Economy of scale Efficiency / Best practice Flexibility Performance Organisation Analysis of Product range Process Technologies Organisation Conceptional design Make or buy Specialisation Capacity increase Technology Standardisation Regulatory aspects Results versus costs


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