Pharmaceutical Facilities

Transcription

1 500 Pharmaceutical Facilities Design, Layouts and Validation Prof. Manohar A. Potdar Department of Quality Assurance Poona College of Pharmacy Bharati Vidyapeeth University Pune India PharmaMed Press An imprint of Pharma Book Syndicate , Giriraj Lane, Sultan Bazar, Hyderabad

2 1948 Contents Foreword. Preface Acknowledgements List of abbreviations Introduction (ix) (xi) (xiii) (xxiii) (xxv) PART-I Chapter 1 Regulatory Requirements for Pharmaceutical Plants 1.1 Introduction Regulatory Requirements Related To Current Good Manufacturing Practices In Pharmaceutical Industry Regulatory Requirements Related to Factories Act - of India and the Maharashtra Factories Rules, Chapter 2 Project Management 2.1 Introduction Project Life Cycle The Project Manager Importance of Proj ect Management 2.2 Defining the Project

3 (xv0 2.3 Estimating Project Time and Cost Introduction Factors Influencing the Quality of Estimates Estimation Guidelines Methods ofestimating Project Time and Cost Level of Details Refining Estimates Developing Project Plan Developing Project Network Constructing a Project Network Activity Fundamentals Managing Risks Introduction Risk Management Process Scheduling Resources Pasis of scheduling Types of Project Constraints Classification of Scheduling Problems Reducing Project Duration Rationale for Reducing Project Duration Qualities of a Project Manager 2.9 Managing Project Teams High Performing Teams Team Development Model Situational Factors Affecting Team Development Qualities of Project Team Member Ground Rules for the Project Team Norms for High-Performance Teams Progress and Performance Measurement and Evaluation Structure of Project Monitoring Information System Project Control Process 66

4 (xvii) 2.11 Project Audit and Closure Identification of tasks Project Audits Performing audits Guidelines for Conducting a Project Audit Project Closure 69 Chapter 3 Pharmaceutical Validation 3.1 Validation of Buildings & Facilities Introduction User Requirement Specifications Design Qualification Installation Qualification Operational Qualification Performance Qualification Validation of HVAC System Validation Protocols for HVAC system Design Qualification Installation Qualification Operational Qualification Performance Qualification 3.3 Water System Validation Introduction Equipment and System Prevalidation of the Total System Design Construction Validation Start Up Validation System Qualifications Approval for Use

5 (xx) 4.4.7(C) Tube Cleaning, Filling, Sealing and Packaging (D) In process Store Rooms (E) I.P.Q.C Room for Manufacturing and Packaging Liquid Oral Department : Introduction Work Station Listing Area and Activity Listing (Input-Process-Output) Capacity Planning Equipment Details Man Power Requirement Work Station and Section Layout (A) Day Stores (B) Liquid Preparation Room (C) Bottle Washing Room (D) Filling Sealing Inspections labeling Packaging Like Sterile Product Introduction Workstation Listing Area and Activity Listing Capacity Planning Equipment Details Manpower Requirement Workstation and Section Layouts (A) Day Stores (B) Solution Preparation Room (C) Solution Filtration and Storage Room (D) 4.6.7(E) Ampoules Washing, Drying, Depyrogenation and Sterilization 208 Rubber Plugs, Seals, Washing, Sterilization and Unit Preparation Room (F) Ampoule Filling and Sealing 210

6 (xxi) 4.6.7(G) Vial filling and Sealing Room (H) Ampoule/Vials Inspection Room (1) Ampoule /Vials Labeling and Packaging Room (J) Recovery Room (Ampoules) (K) In-process Storage Areas (L) Aseptic Process Area Change Room (M) Laundry for Sterile Garments 219 Chapter 5 Support Services Department 5.1 Department Head Office Documentation and Record Room Maintenance Room Tools Room House Keeping Material Store Consumable Stores Drinking Water /Urinals Change Room for Employees (Processing Area) 238 Chapter 6 Support Services for Plants 6.1 Q.C. Department Pharmaceutical Ware House Introduction Receiving and Dispatch Bays Receiving Quarantine Area Raw Material Store Packaging Material Store Sampling and Dispensing Booths Finished Goods Store 247

7 6.3 Administrative Block (xxii) Vehicle Parking Design Sports and Entertainment Block Residence Quarter Design of A Training Hall Canteen Facility for Plant 258 Bibliography 261 Index 263