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cGMP Aspects of Design

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  • 1.             GMP Aspects of Design Pharmaceutical Engineering CSUF Design of Pharmaceutical & Biotech Manufacturing Facilities 8/16/03 Presented by Steve Phillips 1
  • 2.             Expected Outcome(s)• History & Expectations of the GMPs• Manufacturing Facility Delivery Method….. From Concept to Reality!• GMP Aspects of Facility Design 2
  • 3.             AGENDA• Introduction 30 sec• History & Expectations of the GMPs 1 min• Manufacturing Facility Delivery Method 2 min• Document Definition/Description 3 min• Document Definition/Description 3 min• Motion Picture 30 sec 3
  • 4.             History of GMPs Brief History of Regulations – 1906—Food and Drug Act Prevent Adulteration – 1938—Food, Drug & Cosmetic Act Prove Product Safety – 1962—KeFauver Harris Act Prove Product Efficacy – 1976—cGMP’s Proposed Clarity (Validation) 4
  • 5.             History of GMPs cont. Typical Product Cycle 5
  • 6.             History of GMPs cont. Compliance Product Life Cycle: GLP/cGMP 6
  • 7.             Expectation or Legal Basis for cGMP’s “Adulteration” A drug is deemed “adulterated” if … The method used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administrated in conformity with current good manufacturing practice (cGMP) to assure that such drug meets the requirements of this chapter as to safety and has identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess…………………………. FDC Act 501 (a) (2) (B) Food, Drug and Cosmetic Act of 1938 FDC Act 201 (g) (1) “SSIPpQ” 7
  • 8.             Manufacturing Facility Delivery Method 8
  • 9.             InfrastructureGeneral Definition The basic facilities, services, utilities, and support systems for sustaining production operations and support functions in the most reliable, efficient, and cost effective manner. 9
  • 10.             Infrastructure - Delivery Process H2O EF Scrubber Utilities Security Cafeteria HVAC Electrical Architectural Gas Layout, Finishes, G Flows, etc. o Environmental Water w Health & Safety Process n RR CVAC Legally Req. & Parking & ShuttlesOptional Standby Pwr. Phone & Data (Accounting/Applications) CDA BMS Chiller N2 O2 Ar UPS Distribution Offices 10
  • 11.             Manufacturing Facility Delivery Method ProductionIdea Garage Development Research Test & Commission/Qualify Scale Up Facilities Planning 11
  • 12.             Manufacturing Facility Delivery Method Commissioning Startup and Conceptual Basic Detailed Construction and Operation Design Design Design Qualification Support Project Proposal Handover to Client VMP QAP Functional Detail Design URS Specification Specification Impact Assessment IQ Protocol IQ Test Risk Assessment OQ Protocol OQ Test IQ Report PQ OQ Report Fat/Sat DQ DQ DQ 12 Review Review Approval
  • 13.             Manufacturing Facility Delivery Method Commissioning Startup and Conceptual Basic Detailed Construction and Operation Design Design Design Qualification Support Project Proposal Handover to Client User Performance Requirement VMP QAP QualificationSpecification (What) Functional Design Operational (How inFunctional Concept) Detail Design Qualification URS Specification Specification Impact Assessment IQ Protocol IQ Test Risk Assessment Detail DesignOQ Protocol Installation OQ Test (How to Make) Qualification IQ Report PQ OQ Report Fat/Sat DQ DQ Implementation DQ 13 Review Review Approval
  • 14.             Document Definition/Description Conceptual Basic Detailed Design Design Design• VMP-Validation Master Plan The Validation Master Plan (VMP) serves as the validation roadmap, setting the course, justifying the strategy, outlining the preliminary test and acceptance criteria, and documenting the necessary programs that ensure a continuing state of validation. Typical VMP Contents: 1. Introduction 2. Scope 3. Facility Description 4. Commissioning 5. Qualification 6. Process Validation 7. Computer System Validation 8. List of Req. Protocols & Procedures 9. List of Req. SOP’s 10. Equipment & Utility System Descriptions 11. Computer System Description 12. Other cGMP Programs 13. References 14
  • 15.             Document Definition/Description Conceptual Basic Detailed Design Design Design • URS- User Requirement Specifications (customer document) The URS serves as an agreement between production, engineering, validation, and quality assurance for defining what equipment/workspace should do or how to perform. The URS defines the PQ Acceptance Criteria, which tests all functions specified, and shall meet the URS requirements. Typical URS Contents: 1. Laboratory/Workspace Function 2. Spatial & Adjacency Requirements“Without first establishing 3. Room Finishes/EnvironmentEnd user needs & intended 4. Basic HVAC Requirementsuses, it is virtually impossible 5. VBSE Fume HoodsTo confirm that the system can 6. Special HVAC RequirementsConsistently meet the required 7. HVAC Process EquipmentCriteria.” 8. Miscellaneous HVAC Comments 9. Plumbing/Process Piping Fixture Requirements 10. Equipment Plumbing /Process Piping Requirements 11. Electrical Power Requirements 12. Electrical Equipment List 13. Miscellaneous Electrical Comments 14. Lighting 15. Signal Systems 15 16. Approval Signatures
  • 16.             Document Definition/Description Conceptual Basic Detailed Design Design Design• QAP- Quality Activity Plan The QAP serves as a written plan to establish specific guidelines for preparing and handling the quality documentation. The QAP is established during the Basic Design phase of the project. The quality level of the project is stated in the QAP and defines the activities required to achieve the customer, financial and regulatory requirements. The QAP also includes the Project Execution documents to satisfy Good Engineering Practices (GEP). Typical QAP Contents: 1. General Project Execution Documents/Conditions (including paperwork & approval sign off flow diagram) 2. Basis of Design 3. Vendor/Supplier Criteria and Audit Feedback (inc. Training). 4. Project Budget, Estimates, Letter of Justification 5. FAT/SAT Requirements 6. Drawings (CAD Standards) 7. Submittals, Schedules, Request for Information 8. Transmittals, Field Observation Reports, Punch list, Correspondence, & Change Orders 9. Quality Control deviations 10. Project Turnover Package & IQD Requirements 11. Approval Signatures 16
  • 17.             Document Definition/Description Conceptual Basic Detailed Design Design Design• Functional Specification The Functional Specification describes the detailed functions of the equipment (i.e. What the equipment will do), and will be linked to the OQ, which tests all the functions specified. Typical Functional Specification Example: All low points in the path of the steam shall be equipped with automatic valves and steam traps. The valves shall be in the open position during sterilization and in the closed position during all other phases of the operation. 17
  • 18.             Document Definition/Description Conceptual Basic Detailed Design Design Design• Impact Assessment The Impact Assessment is a documented process by which the impact of a system on product quality is evaluated, and the critical components within those systems are identified with a boundary and rationale.• Risk Assessment The Risk Assessment is a documented process by which the design of the facility and its associated appurtenances associated with the project have been evaluated to meet or exceed the requirements of the Food, Drug and Cosmetic Act of 1938. (SSIPpQ) This includes protection of the product, additional products, personnel and buildings. Impact Assessment Process: Risk Assessment Example: 18
  • 19.             Document Definition/Description Conceptual Basic Detailed Design Design Design• Detail Design Specifications The Detail Design Specifications is a complete definition of the equipment in sufficient detail to enable it to be built. The DDS are linked to the IQ which checks that the correct equipment is supplied, to the required standards and that it is installed correctly.• Design Qualification Design Qualification (Enhanced Design Review) of the 3 phases of design, documented at appropriate stages in a project, for conformance to operational and regulatory expectations.Typical Detail Design Specifications Examples: Example DQ (EDR) Team Members:1. All piping will slope at 1/16” per lineal ft. to a drain. 1. Project Manager 2. Discipline Engineers2. ½” Sanitary, normally closed, pneumatically actuated, 3. Design Rep. from Contractors/Vendors diaphragm valves will be installed in all low points. 4. Operations/Production Representative 5. Maintenance Representative3. ½” Sanitary, vertical thermostatic traps shall be 6. Quality & Validation Representative installed downstream of the control valves. 7. EHS Representatives 19
  • 20.             Document Definition/Description Conceptual Basic Detailed Design Design Design• IQ, OQ PQ Protocol The IQ, OQ PQ Protocols are detailed system documents describing testing plans, acceptance criteria, and test results that ensure that a system is installed and operates in accordance with predetermined specifications.• FAT/SAT- Factory Acceptance Test/Site Acceptance Test The FAT is test procedures performed either by the customer, the vendor, or 3 rd party, at the vendor site to ensure that the equipment meets the customer’s specifications The SAT is a brief re-confirmation of the FAT that took place at the vendors site and has now been shipped to the customers site, or if a FAT was not performed. Validation Protocols Example Contents: Example FAT/SAT Benefits: 1. Objective, Scope, & Descriptions 1. Equipment Test Runs. 2. Responsibilities 3. Test Procedures 2. Identification of design & construction shortcomings. 4. Acceptance Criteria 5. Deviation Forms (Field Observation Reports) 3. Training and for the Qualification Team 6. Approvals 7. Attachments 4. Early Data Collection for the IQ,OQ, and PQ . 20
  • 21. NO GMP Aspects Considered in Design & Planning H.M.S. Titanic
  • 22. NO GMP Aspects Considered in Design & Planning
  • 23. NO GMP Aspects Considered in Design & Planning
  • 24. NO GMP Aspects Considered in Design & Planning
  • 25. NO GMP Aspects Considered in Design & Planning
  • 26. NO GMP Aspects Considered in Design & Planning
  • 27. NO GMP Aspects Considered in Design & Planning
  • 28. NO GMP Aspects Considered in Design & Planning
  • 29. NO GMP Aspects Considered in Design & Planning FDA
  • 30. NO GMP Aspects Considered in Design & Planning FDA
  • 31. GMP Aspects Considered in Design & Planning U.S.S 21CFR
  • 32.             Acknowledgements Creator Steve Phillips Animation, Sound & Special Effects Hector O. Torres Steve Phillips 32
  • 33.             Acknowledgements Cast U.S.S 21CFR………..As GMP Designed H.M.S. Titanic……………..As Herself 33