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E-raamat: Manufacturing of Quality Oral Drug Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) [Taylor & Francis e-raamat]

  • Formaat: 188 pages, 41 Tables, black and white; 20 Line drawings, black and white; 20 Illustrations, black and white
  • Ilmumisaeg: 27-Jun-2022
  • Kirjastus: CRC Press
  • ISBN-13: 9781003224716
Teised raamatud teemal:
  • Taylor & Francis e-raamat
  • Hind: 129,25 €*
  • * hind, mis tagab piiramatu üheaegsete kasutajate arvuga ligipääsu piiramatuks ajaks
  • Tavahind: 184,65 €
  • Säästad 30%
Manufacturing of Quality Oral Drug Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API)Suurem pilt
  • Formaat: 188 pages, 41 Tables, black and white; 20 Line drawings, black and white; 20 Illustrations, black and white
  • Ilmumisaeg: 27-Jun-2022
  • Kirjastus: CRC Press
  • ISBN-13: 9781003224716
Teised raamatud teemal:
Taylor & Francis e-raamatudRohkem infot Taylor & Francis e-raamatute kohta
Raamatu kodulehekülg: https://www.taylorfrancis.com/books/9781003224716
This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products.

This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics.

Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.
Preface xi
Acknowledgments xiii
Introduction xv
Authors xix
Chapter 1 Milling and Charging
1(4)
Milling
1(1)
Charging
2(3)
Chapter 2 Granulation
5(4)
PK Blender Manufacturing Process
6(1)
Charging
6(1)
Granulating
7(1)
Milling
7(1)
Final Blending
7(1)
Post Blending
8(1)
Laboratory Analysis of Granulation
8(1)
Critical Elements of the Process
8(1)
Chapter 3 Compression
9(10)
Core Compression Manufacturing Process
13(1)
Line Preparation and Sign-Off
13(1)
Laboratory Analysis of Cores
14(5)
Chapter 4 Sub-coating
19(2)
Sub-coating Manufacturing Process
19(1)
Critical Elements and Trouble Shooting
20(1)
Chapter 5 Membrane Coating
21(8)
Membrane-Coating Manufacturing Process: For Acetone-Based Solutions
23(1)
Critical Elements of Coating Process
24(1)
Aqueous Coaters
24(1)
Membrane-Coating Manufacturing Process: For Methylene Chloride-Based Solution
25(4)
Chapter 6 Drilling
29(6)
In-Process Testing
32(1)
Critical Elements of the Drilling Process
33(2)
Chapter 7 Drying
35(2)
Laboratory Analysis of Cores
36(1)
Chapter 8 Overcoating
37(4)
Overcoating
38(1)
Color Overcoating
39(1)
Laboratory Analysis
39(1)
Critical Elements and Trouble Shooting
39(2)
Chapter 9 Printing
41(4)
Chapter 10 Sorting and Packing
45(4)
Critical Elements of the Sorting Process
46(1)
Packing Overview
47(2)
Chapter 11 Capsule Filling
49(6)
Chapter 12 Safe Handling of APIs and Drugs
55(24)
Definitions
56(1)
Hierarchy of Controls
57(1)
Administrative Controls
57(1)
Personal Protective Equipment (PPE)
57(1)
Hazard Assessment
57(3)
Risk Assessment
60(4)
Control Strategy
64(2)
Hazard Communication
66(1)
Industrial Hygiene (IH) Monitoring Guidelines
67(1)
Definitions
67(3)
Surrogate Monitoring
70(1)
Data Interpretation and Handling
70(1)
Further Notes
71(1)
References
72(1)
Cleaning of Glove Boxes and Biosafety Cabinets
72(1)
Definitions
72(1)
Facts about BSC
73(1)
Prevention of Exposure
73(1)
Personal Protective Equipment Requirements
74(1)
Pre-safety Checklist
74(1)
Cleaning and Decontamination
74(1)
Maintenance, Service, and Certification of BSCs
75(1)
References
75(1)
Facility/Infrastructure Considerations: Laboratory Operations
76(1)
Facility/Infrastructure Considerations: Production and Pilot Plant Operations
76(1)
Containment Control Guidelines/Engineering Matrix: Laboratory Operations
76(1)
Comment
76(1)
Containment Control Guidelines/Engineering Matrix: Production and Pilot Plant Operations
77(1)
Comment
77(2)
Chapter 13 Data Integrity Compliance
79(4)
Process/Procedure: Inventory of Systems
81(1)
Process/Procedure: Determination of 21 CFR Part 11/Data Integrity Applicability
81(1)
Process/Procedure: 21 CFR Coverage Assessment
81(1)
Process/Procedure: 21 CFR Part 11/Data Integrity Gap Analysis
81(2)
Chapter 14 Guidelines for Statistical Procedure
83(12)
Process Capability Analysis
84(2)
Long-Term Studies
86(1)
Acceptance Sampling
87(1)
Attribute and Variable Sampling Plans
87(1)
Variable Sampling Plans: ANSI Z1.9
87(1)
Normality
88(2)
Transformation of Non-normal Data (Normalization)
90(1)
Protocol Sampling
90(1)
Failure Mode and Effect Analysis (FMEA)
90(2)
Calculating or Recalculating Control Limits
92(3)
Chapter 15 Calibration
95(10)
Contingency Plan/Disaster Recovery
104(1)
Chapter 16 Clean-In-Place (CIP) Systems
105(10)
PTS
106(1)
Mix Tank and Discharge Piping
106(1)
STS Circuit
106(1)
Lifecycle Requirements
106(1)
Product and Process User Requirements
107(1)
Process Quality Requirements
107(1)
Process Parameter Requirements
107(1)
Installation User Requirements
108(3)
Operational Requirements
111(1)
Functions (FCT)
112(1)
Process Control System
112(1)
Equipment Alarms and Warnings
112(1)
Data
112(1)
Power Loss and Recovery
112(1)
Cleaning and Sanitizing
113(1)
Material/Waste Movement Requirements
113(1)
Maintenance Requirements
113(1)
Training and Documentation Requirements
113(2)
Chapter 17 Cleaning Validation
115(12)
New Products and Product Changes
117(1)
Cleaning Processes and Changes
117(1)
Risk Assessment/Matrix Approach
117(1)
Matrix Development
118(1)
Cleaning Processes (Manual and Automated)
118(1)
Critical Process Parameters/Critical Quality Attributes
119(1)
Cleaning Validation Life Cycle: Cleaning Method Development
119(1)
Strategy for Process Controls
120(1)
Worst-Case Identification: Product/Component
120(1)
Equipment
120(1)
Validation Tests/Inspections: Visual Inspection
121(1)
Chemical Testing
121(1)
Microbiological Testing
121(1)
Endotoxin Testing
122(1)
Sampling Methods
122(1)
Direct Swab Sampling
122(1)
Rinse Sampling
122(1)
Coupon Testing
122(1)
Sampling Sites
122(1)
Acceptance Criteria
122(1)
Residual Levels
123(1)
Endotoxin Levels
123(1)
Microbiological Levels
123(1)
Cleaning Agents/Sanitizer Validation Studies
123(1)
Hold Time Development
124(1)
Dirty Hold Time
125(1)
Clean Hold Time
125(1)
Additional Hold Times/Cleaning Frequencies
125(1)
Continuous Process Verification
125(1)
Failure Investigations
125(2)
Chapter 18 Manufacturing Process Validation
127(8)
Chapter 19 Risk-Based Life Cycle Management
135(14)
Process Flow Diagram
140(1)
Essential Requirements (Requirements List)
140(1)
Linkage Document (Trace Matrix): Historical Document
140(1)
Process Failure Mode and Effects Analysis (pFMEA)
141(1)
Control Plan
141(1)
Assessment of Process Flow Diagram/pFMEA/Control Plan Documents
142(1)
Assessment of Test Method Validation Documents
142(1)
Assessment of Process Validation and Manufacturing Instruction Documents
142(1)
Product Performance Data
143(1)
Production Process Data Collection (PPDC)
144(1)
Assessment of Risk Controls (Control Strategy)
145(1)
Maintaining "Living Documents" Updates to the Play book Documentation
146(1)
Document Management
147(1)
Playbook Updates/Approvals (Live System)
147(1)
RBLCM Data Collection
147(2)
Chapter 20 pFMEA Manufacturing Procedure
149(4)
Chapter 21 Analytical Methods Development, Validation, and Transfer
153(18)
HPLC
154(1)
HPLC: Case Study
155(1)
Guidelines: Formulating Mobile Phases for Various Reversed Phase HPLC Columns
155(6)
Case Study: HPLC Columns Comparison
161(2)
HPLC Columns
163(1)
High Efficiency and Symmetrical Peaks
163(2)
Universal Reversed-Phase HPLC Column Simplifies Method Development
165(1)
HPLC Troubleshooting and Guide
166(1)
Isolating Pump Problems
167(1)
Column Protection
168(1)
Getting the Most from Analytical Column
168(1)
Solving Detector Problems
168(1)
Column Heater, Recorder
168(1)
Keeping Accurate Records
169(1)
Further Recommendations
169(1)
Restoring Column's Performance
169(1)
Nonbonded Silica Columns Exposed to Polar Solvent
169(1)
Performance Evaluation Mixes for HPLC Columns
169(1)
Preventing and Solving Common Hardware Problems
170(1)
Preventing Leaks
170(1)
Unclogging the Column Frit
170(1)
Appendix I API Terms 171(2)
Appendix II Impurities -- FDA Directive 173(6)
References 179(2)
Bibliography 181(4)
Index 185
Dr. Sam A. Hout is a chartered chemical engineer and certified in business management by the American Production and Inventory Control Society (APICS). He also is a member of the International Society of Pharmaceutical Engineers (ISPE) and specializes in process engineering and business process improvement. He received his education and training in the UK (Ph.D. Chemical Engineering, University of Bath) and in the United States (MBA, University of California). For the past 20 years in aseptic manufacturing, he held the position of Sr. Director of Engineering, project management, and technology process transfers at SIEGFRIED Pharmaceuticals. Previously, Dr. Hout has held the position of Sr. Manager of Engineering at TEVA Pharmaceuticals, parenteral medicines in Irvine, California. These specialty divisions produced sterile injectable drugs for hospital institutional markets worldwide.

Prior to assuming the position at Teva, Dr. Hout was Director of Operations at PHENOMENEX, the leading global company in HPLC (High Performance Liquid Chromatography) for drug separation and analysis. During the past thirty years, Dr. Hout has helped to guide leading companies in technical positions such as J&J, Medtronic, and Fischer Scientific in developing and producing medical devices and diagnostic standards that combat disease and promote healthier lives. In working with a global market, Dr. Hout travels frequently throughout the United States, Europe and the Far East.
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