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Pharmaceutical Vendors Approval Manual: A Comprehensive Quality Manual for API and Packaging Material Approval [Kõva köide]

  • Formaat: Hardback, 152 pages, kõrgus x laius: 234x156 mm, kaal: 453 g, 1 Line drawings, black and white; 1 Halftones, black and white; 2 Illustrations, black and white
  • Ilmumisaeg: 13-Dec-2021
  • Kirjastus: CRC Press
  • ISBN-10: 1032030887
  • ISBN-13: 9781032030883
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Pharmaceutical Vendors Approval Manual: A Comprehensive Quality Manual for API and Packaging Material ApprovalSuurem pilt
  • Formaat: Hardback, 152 pages, kõrgus x laius: 234x156 mm, kaal: 453 g, 1 Line drawings, black and white; 1 Halftones, black and white; 2 Illustrations, black and white
  • Ilmumisaeg: 13-Dec-2021
  • Kirjastus: CRC Press
  • ISBN-10: 1032030887
  • ISBN-13: 9781032030883
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Teised raamatud sellest sooduspakkumisest: Kevadine sooduspakkumine - kuni 31. maini üle miljoni raamatu kuni 25% soodsamalt
Püsilink: https://www.kriso.ee/db/9781032030883.html
Märksõnad:
This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendors assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications.

This book











provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements





covers basic quality concepts and the elements of vendors assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies





provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry





provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract

Provided material can be easily tailored to incorporate changes to add in-house vendors qualification requirements.

Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.
Preface xiii
Author xvii
Chapter 1 Finding and Partnering Active Pharmaceutical Ingredients Vendor 1(12)
Selection and Management
1(12)
Ongoing Approval/Management
5(1)
Auditing Suppliers Manufacturing Facility
6(1)
Purchasing and Management
6(1)
Maintaining the Supply Chain
6(1)
Periodic Evaluation with Supplier
7(1)
Ongoing Monitoring
8(1)
Classification of Supplier
8(1)
Re-Audit
9(1)
Re-Assessment
9(1)
Reduced Testing
9(4)
Chapter 2 Selection of API Vendors and the Impacts on Drug Products 13(10)
How it Impacts the Drug Products
13(6)
API Supplier Selection Process Modules
19(2)
API Supplier Impact on Generic Drug Product
21(1)
Conclusion
21(2)
Chapter 3 Approach, Team Formation, and Planning 23(8)
QUEST
23(2)
Q = Question Phase
23(1)
U = Understanding Phase
23(1)
E = Evaluation Phase
23(1)
S = Site Audit Phase
24(1)
T = Track Phase
24(1)
Phase I
25(1)
Phase II of Planning
26(1)
Execution
27(1)
Contacting Suppliers
27(1)
Roadblocks, Challenges, and Surprises
28(2)
Poor Quality Raw Materials
28(1)
Poor Yield Percentage
29(1)
Anomalies with Commercial Scale Batch
29(1)
Analytical Challenges
29(1)
Conclusion
30(1)
Chapter 4 Site Standard Operating Procedure for Vendors Approval 31(8)
Vendor Evaluation and Approval Procedure
31(10)
Purpose
32(1)
Responsibility
32(1)
Procedure
32(14)
Responsibilities of Purchase Department
32(1)
Responsibilities of Quality Control Department
32(2)
Responsibilities of QA Department
34(1)
Responsibilities of QA Director
35(4)
Chapter 5 Vendors Evaluation Records: Buyer Company's Name 39(2)
Chapter 6 Document Status Checklist 41(2)
Attachment A
42(1)
Chapter 7 Declaration and Quality Commitment 43(2)
Attachment B
43(2)
Chapter 8 Manufacturing Facility Self-Evaluation Questionnaire 45(10)
Brief Company History
46(1)
For Example
46(7)
Management Profile
47(6)
Vendor Related Information
53(2)
Chapter 9 Sterile Bulk Manufacturing Facility Self-Evaluation Questionnaire 55(14)
Review Form
67(2)
Chapter 10 Quality Agreement 69(2)
Chapter 11 Covering Letter for Supplier 71(2)
Chapter 12 Quality Agreement for Generic APIs 73(14)
Definitions
74(1)
Pertinent GMP Standard
75(1)
Certificate of Analysis/Compliance
75(1)
Change Control
75(1)
Audit
76(1)
Authority Inspections
76(1)
Sub-Contracting
76(1)
Retention of Samples
76(1)
Retention of Records/Documentation
77(1)
Stability of Material
77(1)
Customer's Complaints
77(1)
Recall
78(1)
Annual Quality Review
78(1)
Storage and Distribution Practices
78(1)
Contaminants
78(1)
BSE/TSE
78(1)
Residual Solvents
79(1)
Metal Catalyst/Reagent Residues
79(1)
Controlled Pharmaceutical Ingredients
79(1)
QualificationNalidation
79(1)
Reprocessing, Salvaging, and Reworking
79(1)
Deviations/00S Results
80(1)
Packaging
80(1)
Regulatory Documents
80(1)
Product Release
80(1)
Reference Standards
80(1)
Material Specifications
81(1)
Analytical Methods
81(1)
General Provisions
81(3)
Entire Agreement
81(1)
Assignment
81(1)
Severability
81(1)
Waiver
81(1)
Further Documents
82(1)
Unforeseeable Circumstances
82(1)
Governing Law
82(1)
Notices
82(1)
Forms
82(1)
Titles
83(1)
Intellectual Property
83(1)
Relationship of the Parties
83(1)
Advertising
83(1)
Counterparts
83(1)
Authorized Signatories
83(1)
Term
84(1)
Annex: Division of Responsibilities
84(3)
Chapter 13 API Audit Checklist 87(18)
Table of Contents
87(1)
Quality Management
87(3)
Personnel
90(2)
Buildings and Facilities
92(2)
Process Equipment
94(1)
Documentation and Records
95(1)
Materials Management
96(1)
Production and In-Process Controls
97(1)
Packaging and Labeling of APIs
98(1)
Storage and Distribution
99(1)
Laboratory Controls
100(2)
Validation
102(1)
Change Control
103(1)
Re-worked and Rejected Materials
103(1)
Complaints and Market Recalls
104(1)
General Queries
104(1)
Chapter 14 Audit Report 105(14)
Contents
108(1)
A Objective
109(1)
B Scope
109(1)
C Assessment Background
109(9)
1 Introduction
109(1)
2 API Overview
109(1)
3 Organization
109(1)
4 Site Activities
109(1)
5 Technical Operational Activities
109(1)
6 Company's Technical Operational Activities Are as Follows
109(1)
7 Major Customers
110(1)
8 R&D
110(1)
9 Regulatory Affairs
110(1)
10 Health, Safety, and Environment
110(1)
11 Personnel
110(1)
12 Water System
110(1)
13 Computerized Systems
110(1)
14 Materials Management
111(1)
15 Warehouse, Sampling, and Testing of Incoming Packaging and Raw Materials for Production
111(1)
16 Observations
112(7)
16.1 Productions
112(1)
16.2 Quality Unit
113(1)
16.3 Compliance System
113(1)
16.4 In-Process Controls
113(1)
16.5 Packaging Materials
113(1)
16.6 Packaging and Labeling Operations
113(1)
16.7 Laboratory Controls
113(2)
16.8 Microbiology Lab
115(1)
16.9 Certificates of Analysis
115(1)
16.10 Stability Monitoring
115(1)
16.11 Calibration
116(1)
16.12 Reserve/Retention Samples
116(1)
16.13 Validations
116(1)
16.14 Complaints and Recalls
117(1)
16.15 Training System
117(1)
16.16 Inspection History
117(1)
D Classification of Audit Findings
118(1)
E Conclusion
118(1)
Chapter 15 Cell Lines Vendors Selection for Biological products 119(8)
The Influential Factors for Choosing the Cell Line
119(4)
Quality Standards Requirements for Cell Line Manufacturers
121(2)
Required Documents from the Vendors
123(1)
Inspection Approach
123(1)
Challenges for Cell Lines Suppliers
124(1)
Challenges in Using a Different Host Cell Than the Reference Product
125(1)
Storage and Shipment of Cell Banks
126(1)
Environmental Controls of Cell Bank's Storage
126(1)
Cell Bank Recovery and Shipment
126(1)
Chapter 16 Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients 127(22)
I Introduction
129(1)
II Questions and Answers
130(17)
A Scope
130(1)
B Quality Management
130(1)
C Personnel
131(1)
D Buildings and Facilities-Containment
132(1)
E Process Equipment-Cleaning
133(1)
F Documentation and Records
134(1)
G Materials Management
135(1)
H Production and In-Process Controls
136(1)
I Packaging and Identification Labeling of APIs and Intermediates
137(1)
J Storage and Distribution
137(1)
K Laboratory Controls
138(1)
L Validation
139(1)
M Change Control
140(1)
N Rejection and Reuse of Materials
140(1)
O Complaints and Recalls
141(1)
P Contract Manufacturers
142(1)
Q Agents, Brokers, Traders, Distributors, Repackers, and Relabelers
142(1)
R Specific Guidance for APIs Manufactured by Cell Culture/Fermentation
143(1)
S APIs for Use in Clinical Trials
144(1)
T Glossary
144(3)
References
147(2)
Index 149
Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.