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 vendor’s 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 vendor’s 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 vendor’s qualification requirements.
Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.
Author(s): Erfan Syed Asif
Publisher: CRC Press
Year: 2021
Language: English
Pages: 169
City: Boca Raton
Cover
Half Title
Title Page
Copyright Page
Table of Contents
Preface
Author
Chapter 1 Finding and Partnering Active Pharmaceutical Ingredients Vendor
Selection and Management
Ongoing Approval/Management
Auditing Suppliers Manufacturing Facility
Purchasing and Management
Maintaining the Supply Chain
Periodic Evaluation with Supplier
Ongoing Monitoring
Classification of Supplier
Re-Audit
Re-Assessment
Reduced Testing
Chapter 2 Selection of API Vendors and the Impacts on Drug Products
How It Impacts the Drug Products
API Supplier Selection Process Modules
API Supplier Impact on Generic Drug Product
Conclusion
Chapter 3 Approach, Team Formation, and Planning
QUEST
Q = Question Phase
U = Understanding Phase
E = Evaluation Phase
S = Site Audit Phase
T = Track Phase
Phase I
Phase II of Planning
Execution
Contacting Suppliers
Roadblocks, Challenges, and Surprises
Poor Quality Raw Materials
Poor Yield Percentage
Anomalies with Commercial Scale Batch
Analytical Challenges
Conclusion
Chapter 4 Site Standard Operating Procedure for Vendors Approval
Vendor Evaluation and Approval Procedure
Purpose
Responsibility
Procedure
Responsibilities of Purchase Department
Responsibilities of Quality Control Department
Responsibilities of QA Department
Responsibilities of QA Director
Chapter 5 Vendors Evaluation Records: Buyer Company’s Name
Chapter 6 Document Status Checklist
Attachment A
Chapter 7 Declaration and Quality Commitment
Attachment B
Chapter 8 Manufacturing Facility Self-Evaluation Questionnaire
Brief Company History
For example
Management Profile
Vendor Related Information
Chapter 9 Sterile Bulk Manufacturing Facility Self-Evaluation Questionnaire
Review Form
Chapter 10 Quality Agreement
Chapter 11 Covering Letter for Supplier
Chapter 12 Quality Agreement for Generic APIs
Definitions
Pertinent GMP Standard
Certificate of Analysis/Compliance
Change Control
Audit
Authority Inspections
Sub-Contracting
Retention of Samples
Retention of Records/Documentation
Stability of Material
Customer’s Complaints
Recall
Annual Quality Review
Storage and Distribution Practices
Contaminants
BSE/TSE
Residual Solvents
Metal Catalyst/Reagent Residues
Controlled Pharmaceutical Ingredients
Qualification/Validation
Reprocessing, Salvaging, and Reworking
Deviations/OOS Results
Packaging
Regulatory Documents
Product Release
Reference Standards
Material Specifications
Analytical Methods
General Provisions
Entire Agreement
Assignment
Severability
Waiver
Further Documents
Unforeseeable Circumstances
Governing Law
Notices
Forms
Titles
Intellectual Property
Relationship of the Parties
Advertising
Counterparts
Authorized Signatories
Term
Annex: Division of Responsibilities
Chapter 13 API Audit Checklist
Table of Contents
Quality Management
Personnel
Buildings and Facilities
Process Equipment
Documentation and Records
Materials Management
Production and In-Process Controls
Packaging and Labeling of APIs
Storage and Distribution
Laboratory Controls
Validation
Change Control
Re-worked and Rejected Materials
Complaints and Market Recalls
General Queries
Chapter 14 Audit Report
Contents
A. Objective
B. Scope
C. Assessment Background
1. Introduction
2. API Overview
3. Organization
4. Site Activities
5. Technical Operational Activities
6. Company’s Technical Operational Activities Are as Follows
7. Major Customers
8. R&D
9. Regulatory Affairs
10. Health, Safety, and Environment
11. Personnel
12. Water System
13. Computerized Systems
14. Materials Management
15. Warehouse, Sampling, and Testing of Incoming Packaging and Raw Materials for Production
16. Observations
16.1 Productions
16.2 Quality Unit
16.3 Compliance System
16.4 In-Process Controls
16.5 Packaging Materials
16.6 Packaging and Labeling Operations
16.7 Laboratory Controls
16.8 Microbiology Lab
16.9 Certificates of Analysis
16.10 Stability Monitoring
16.11 Calibration
16.12 Reserve/Retention Samples
16.13 Validations
16.14 Complaints and Recalls
16.15 Training System
16.16 Inspection History
D. Classification of Audit Findings
E. Conclusion
Chapter 15 Cell Lines Vendors Selection for Biological products
The Influential Factors for Choosing the Cell Line
Quality Standards Requirements for Cell Line Manufacturers
Required Documents from the Vendors
Inspection Approach
Challenges for Cell Lines Suppliers
Challenges in Using a Different Host Cell Than the Reference Product
Storage and Shipment of Cell Banks
Environmental Controls of Cell Bank’s Storage
Cell Bank Recovery and Shipment
Chapter 16 Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients:
I. Introduction
II. Questions and Answers
A. Scope
B. Quality Management
C. Personnel
D. Buildings and Facilities—Containment
E. Process Equipment—Cleaning
F. Documentation and Records
G. Materials Management
H. Production and In-Process Controls
I. Packaging and Identification Labeling of APIs and Intermediates
J. Storage and Distribution
K. Laboratory Controls
L. Validation
M. Change Control
N. Rejection and Reuse of Materials
O. Complaints and Recalls
P. Contract Manufacturers
Q. Agents, Brokers, Traders, Distributors, Repackers, and Relabelers
R. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation
S. APIs for Use in Clinical Trials
T. Glossary
References
Index
