CONTENTS PART-I. Chapter 1 Regulatory Requirements for Pharmaceutical Plants. Chapter 2 Project Management

Transcription

1 CONTENTS Foreword...(ix) Preface...(xi) Acknowledgement... (xiii) List of abbreviations... (xxiii) Introduction... (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 Project Management Defining the Project... 41

2 (xvi) 2.3 Estimating Project Time and Cost Introduction Factors Influencing the Quality of Estimates Estimation Guidelines Methods of Estimating 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 Basis of scheduling Types of Project Constraints Classification of Scheduling Problems Reducing Project Duration Rationale for Reducing Project Duration Qualities of a Project Manager 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

3 (xvii) 2.11 Project Audit and Closure Identification of tasks Project Audits Performing audits Guidelines for Conducting a Project Audit Project Closure 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 Water System Validation Introduction Equipment and System Prevalidation of the Total System Design Construction Validation Start Up Validation System Qualifications Approval for Use

4 (xviii) PART-II Chapter 4 Pharmaceutical Facilities Design 4.1 Tablet Department Introduction Work Station Listing Area and Activity Listing (Input Process - Output) Capacity Planning Equipment Details Man Power Requirement Work Stations and Section Layouts (A) Day Stores (B) Granulation Room (C) Lubrication Room (D) Tablet Compression Room and Granules Feeding Room (E) Tablet Inspection Room (F) Tablet Coating Room (G) Primary Packaging Rooms (H) Secondary Packaging Room (I) In-process Storage Rooms (J) IPQC LABS (K) Process Change Room (L) Wash-Room (M) Office, Documentation and Record Room (N) Tool Room (Change Parts Room) (O) Maintenance Room (P) House Keeping Materials Room (Q) Consumable Store (R) Equipment Wash Room (S) F.B.D Bags Washing Drying Room (T) F.B.D Clean Bag Store

5 (xix) 4.2 Capsule Department Introduction Work Station Listing Area and Activity Listing ( Input- Process Output ) Capacity Planning Equipment Details Man Power Requirement Work Station and Section Layouts (A) Day Stores (B) Mixing and Lubrication (C) Capsule Filling and Sealing Room Dry Syrups Introduction Work Station Listing Area and Activity Listing (Input- Process - Output) Capacity Planning Equipment Details Man Power Requirement Work Station and Section Layouts (A) Day Store (B) Mixing and Lubrication (C) Bottle Cleaning, Bottle Filling and Sealing (D) Inspection Labeling and Packaging Ointments Department Introduction Work Station Listing Area and Activity Listing (Input Process-Output) Capacity Planning Equipment Details Man Power Requirement Work Station and Section Layouts (A) Day Stores (B) Ointment Manufacturing

6 (xx) 4.4.7(C) Tube Cleaning, Filling, Crimping 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 Line Sterile Products Introduction Work Station Listing Area and Activity Listing Capacity Planning Equipment Details Man Power Requirement Workstation and Section Layouts (A) Day Stores (B) Solution Preparation Room (C) Solution Filtration and Storage Room (D) Ampoules Washing, Drying, Sterilization and Depyrogenation (E) Rubber Plugs, Seals, Washing, Sterilization and Unit Preparation Room (F) Ampoule Filling and Sealing

7 (xxi) 4.6.7(G) Vial Filling and Sealing Room (H) Ampoule / Vials Inspection Room (I) 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 Biopharmaceutical Products Department Raw Material Storage/Handling/Dispensing Media/Buffer/Component Preparation/Hold lnoculum Preparation Fermentation/Cell Culture Recovery/Harvest Purification Bulk Filling Summary Schematic Examples of Primary Segregation in Facility Design Single Product / Minimal Segregation 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)

8 (xxii) Chapter 6 Support Services for Plants 6.1 Q.C. Department Pharmaceutical Warehouse Introduction Receiving and Dispatch Bays Receiving Quarantine Area Raw Material Store Packaging Material Store Sampling and Dispensing Booths Finished Goods Store Administrative Block Vehicle Parking Design Sports and Entertainment Block Residence Quarter Design of a Training Hall Canteen Facility for Plant Bibliography Index