Pharmaceutical Vendors Approval Manual: A Comprehensive Quality Manual for API and Packaging Material Approval

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