Preface to the First Edition
1. MANAGING PHARMACEUTICAL FACILITIES: Introduction; Role of a Facility Manager; Financial Management; Facilities Condition Assessment (Audit); Pharmaceutical Facility Validation; Facility Design Qualification; Facility Installation Qualification; Facility Operational Qualification; Utility Systems; Safety for Facility Management.
2. SUSTAINABLE FACILITIES: Ecosystems; Sustainable Manufacturing; Current Scenario; Green Chemistry; Process Mass Intensity; Green Solvents; Green Engineering; Sustainable Buildings; Sustainable Energy Management; Cleanrooms (HVAC); Facility Lighting; Electric Motors; Compressed Air; Boilers; Sustainable Water Management.
3. OPERATIONAL EXCELLENCE IN PHARMA MANUFACTURING: Introduction; Focus on Manufacturing Efficiency; Current Efficiency Levels; Continuous Processing of Pharmaceuticals; Automated Manufacturing; Good Automated Manufacturing Practices (GAMP); ASTM E2500; Optimizing Batch Sizes and Cycle Times; Overall Equipment Effectiveness; Corporate Manufacturing Strategy.
4. PRODUCTION ISSUES: Tablets/Capsules; Introduction; Blenders; Dryers; Tablet and Capsule Equipment; Granulation Mix Analysis; In Process Testing; Process Notes; Common Problems in Tabletting; Liquid Orals; Process Notes; Topical Preparations; Potency Uniformity; Equipment and Production Control; Preservatives Used in Topical Preparations; Preservatives Used in Ophthalmic Preparations; Pharmaceutical Water Systems; System Validation; Microbial Limits; Water for Injection Systems; Purified Water Systems.
5. EQUIPMENT CLEANING AND MAINTENANCE: Introduction; Maintenance Methodologies; Lean Maintenance; Calibration of Equipment; Procedure; Calibration Program; Calibration Standards; Calibration Procedures; Instrument Maintenance Records; Calibration Instruments; Electric Motors; Basic guidelines; Motor Repair / Replacement Decisions; Economic Comparison; Centrifugal Pumps; Fluid Bed Dryer; Mass Mixer; Multimill; Planetary Mixer; High Shear Mixer Granulator (Rapid Mixer Granulator); Sifter; Tray Dryer; Wurster Coater Dryer; Double Cone Blender; Tablet Compression Machine; Inspection and Maintenance of Compression Tooling; Common Problems Encountered with Tablet Tooling; Vibratory Tablet De-Duster; Conventional Coating Pan; Polishing Pan; Strip Sealing Machine; Capsule Autoloader; Capsule Inspection Cum Polishing Machine; Dry Syrup Powder Filling Machine; Capsule Filling Machine (Manual); Capsule Filling Machine (Semi-Automatic); Tanks, Accessories, Utensils And Stirrers; Filter Press; Liquid Oral Filling Machine; Bottle Labeling Machine; Component Preparation Tank; Melting Tank; Ointment Mixer (Silverson Type); Ointment Bulk Storage Drum; Tube Filling Machine; Equipment For Sterile Products (General); Sterile Product Vessels; Stirrer; Vials /Ampoules Washing Machine; Rubber Stopper Washing Machine; Membrane Filter Holder; Filtration Tubing; Ampoule Filling And Sealing Machine; Vial /Ampoule Filling Assemblies And Accessories; Autoclave; Preventive Maintenance ; Vial Sealing Machine; Vial/Ampoule Inspection Machine; Compressed Air; Boiler; The Boiler Room; Piping Systems; Steam Traps; Water Treatment; Pumps; The Venting System; The Boiler; Test Firing; HVAC/R; Fans; Air-Handling Unit; Chillers and Condensers; Cooling Towers; Ducts Cleaning; Clean Room Monitoring; Safety Tips for HVAC Maintenance; Pharmaceutical Water; Cleaning of Piping; Passivation; Sanitization; Setting up a Machine Shop; Guidelines and Suggestions; Safety; Maintenance; Regulatory and Compliance Issues.
6. COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM: Introduction; Computerized Maintenance Management Systems (CMMS); Advantages of CMMS; Guidelines for Small Companies; Implementation of CMMS; Implementation Basics; Framework for Transition; Preventive Maintenance; Continuous Process; Automatic Data Collection; Elements of CMMS; Work Order; Assets; Location; Preventive; Employee; Masters; Reports; Work Orders; How to Open a New Work Order; Filter Out Work Order Information; Close a Work Order; Add Labour in the Work Order; Direct Issue in a Work Order; View Total Cost of a Work Order; Assets; Add a New Asset; How to Filter out Assets Information; Add a New Location; Filter Out Location Information; Employee/Requester; Add a New Employee/Requester; Filter Out Employee/Requester Information; Preventive Maintenance; Register a New PM Task; Filter Preventive Maintenance Schedules; Generate PM Work Orders; Masters; Department; Failure Code; Assets Category; Suppliers/Contractors; Reports.
7. WORK ENVIRONMENT AND SAFETY: Housekeeping; Introduction; Capsule Department; Tablet Department ; Liquid Oral Department; Ointment Department; Sterile Area; Raw, Packing and Finished Goods Stores; Pest Control And Disinfection; Managing Older Buildings; Roofing Maintenance; Indoor Air Quality; Disaster Management; Planning For an Emergency; Damage Control; Safety; Safety Audits; Pharmaceutical Hazardous Areas; Safety Procedures; Safety Management through Air Handling Systems; Fire Detection and Control; Hazards Specific to Pharmaceutical Industry; Pharmaceutical Manufacturing Precautions; Personal Protective Equipment; Electrical Safety; Electrical Safety Regulations and Standards; Electrical Safety Program; Electrical Hazards; Work Procedures, Tools and PPE; Safety by Design; First Aid; Facility Security.
8. TRAINING: Introduction; Writing a Training Program; Structure of Training Programs; Conducting Training Sessions; Class; Objectives; Material; Props; Lesson Plan; Environment; Training Pointers; Tips To Become a Better Trainer; Presentation Skills; Body Language; The Role of Questions; Assessment; Documentation of Training; A Case Study; Sample Training Programs; Training Program for Supervisors; Training Program for Workmen; Training Program for Clean Room; Training Program for Autoclave; Training Program for Dry Heat Sterilizer; Training Program for Janitors; Training Program for Laminar Air-Flow; Training Program for Membrane Filter Holder; Training Program for Personal Hygiene; Training Program for Production Supervisor; Training Program for Sterile Stoppering; Training Program for Workmen.
9. VALIDATION: Introduction; Purpose of Validation and Qualification; Responsibility for Validation and Qualification; Validation Master Plan; Purpose; Format and Content; Installation and Operational Qualification; Introduction; Installation Qualification (lQ); Operational Qualification (OQ); Re-Qualification; Non-Sterile Process Validation; Introduction; Prospective Validation; Concurrent Validation; Retrospective Validation; Re-validation; Change Control; Cleaning Validation; Introduction; Documentation; Sample Formats; Format for an installation qualification protocol; Format for an operational qualification protocol; Format for a performance qualification protocol; Examples of IQ, OQ, and PQ Protocols; Content Requirements for Equipment/Systems; Water for Injection; Temperature Controlled Equipment; Centrifuges; Blenders, mixers and homogenizers; Pumps; Backup Power Generator; Controlled Air Equipment; Measuring Apparatus; Filter for Integrity Testing Apparatus; Format for a Process Validation Protocol; Validation Protocols.
10. ENVIRONMENTAL MONITORING: Introduction; Pharmaceutical Products; Botanicals; Pharmaceutical Preparations; Diagnostic Substances; Biological Products; Industrial Processes In The Pharmaceutical Industry; Research and Development; Production of Bulk Pharmaceutical Chemicals; Chemical Synthesis; Natural Product Extraction; Fermentation; Formulation into Final Dosage Forms; Raw Material Inputs And Pollutant Outputs; Air Pollution; Bulk Manufacturing; Formulation; Air Pollution Control Equipment; Condensers; Scrubbers; Combustion or Incineration; Adsorption; Wastewater; Solid Wastes; Pollution Prevention; Material Substitutions; Process Modifications; Good Operating Practices.
11. REGULATORY INSPECTIONS: Introduction; Trends In Regulatory Inspections; Managing Regulatory Inspections; SOP for Regulatory Inspections; Staff Training for Inspection; What Inspectors look for in a GMP Audit; Good Practices for Hosting Regulatory Inspections; Inspections of Foreign Pharmaceutical Manufacturers; Inspection of Quality Systems/GMP Audit; Records; Organization and Personnel; Buildings and Facilities; Equipment; Storage of Raw and Packing Materials; Production and Process Controls; Critical Manufacturing Steps; Equipment Identification; In-Process Testing; Packaging and Labeling; Laboratory Controls; Control Records; Returned Drug Products; Inspection Of Tablet/Capsule Section; Raw Material Receipt and Granulation; Tablet Compression and Coating/Capsule Filling; Inspection of Liquid Orals Section; Equipment; Compounding; Packaging; Inspection of Topical Products Section; Manufacturing; Filling and Packaging; Cleaning; Microbiological Controls (Non-Sterile Topicals); Inspection of Sterile Products; Facilities; Environment; Equipment; Water for Injection; Sterilization; Packaging; Personnel Practices; Inspections of Quality Control Laboratories; Out-of-Specification (OOS) Laboratory Results; Laboratory Errors; Laboratory Investigations; Formal Investigations; Investigation Documentation; Product Failures; Retesting; Resampling; Averaging Results of Analysis; Microbiological; Laboratory Records and Documentation; Laboratory Standard Solutions; Methods Validation; Equipment; In Process Controls and Specifications; Stability; Computerized Laboratory Data Acquisition Systems; Laboratory Management; Inspection of Utilities; HVAC; Pharmaceutical Water System; Pharmaceutical Steam Systems; Compressed Air.
Reference Data for Plant Managers