Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance

The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

INTRODUCTION
Project Description
What is a Validation Master Plan
Scope of a Validation Master Plan
Definition of the Term Validation
Validation Team Members
Validation Team Responsibilities
CONCEPT OF QUALIFICATION / VALIDATION
Fundamentals
Concept of a Validation Life Cycle
Elements of Qualification/Validation
Documentation Format of Qualification Programs
Numbering System
REVALIDATION
RESPONSIBILITIES
FACILITY DESCRIPTION
Line Capacities
DESCRIPTION OF BUILDING
Dry Production Facility: Building A
Liquid and Semisolid Production Facility: Building B
Parenterals Production Facility: Building C
EQUIPMENT DESCRIPTION
Dry Production Facility: Building A
Liquid and Semisolid Production Facility: Building B
Parenterals Production Facility: Building C
Over- Printing Area
Quality Control
Quality Assurance (In-Process)
Product Development Laboratories
HVAC DESCRIPTION
Dry Production Facility: Building A
Liquid and Semisolid Production Facility: Building B
Parenterals Production Facility: Building C
Over-Printing Area
Quality Control
Quality Assurance (In-Process)
Product Development Laboratories
UTILITIES DESCRIPTION
Deionized Water (DI Water)
Purified Water
Water for Injection (WFI)
Chilled Water
Pure Steam
Compressed Air
Nitrogen (N2)
Carbon Dioxide (CO2)
Electric Power
Sanitary Water
HVAC (Heating, Ventilation, and Air Conditioning) System
VALIDATION PROGRAM OVERVIEW
Validation Project Management: Organization
Validation Responsibilities
Design and Validability Review
Validation Documents
Installation Qualification Protocols
Operational Qualification Protocols
Change Control Initiation
Cycle Development
Performance Qualification Protocols
Process Validation Protocols
Validation Final Reports
Validation Package
Certificate for Use in Manufacturing
Required Protocols and Procedures for Dry Production: Building A
Required Protocols and Procedures for Liquid and Semisolid Production: Building B
Required Protocols and Procedures for Parenterals Production: Building C
CALIBRATION PROGRAM SUMMARY
PREVENTATIVE MAINTENANCE PROGRAM SUMMARY
KEY STANDARD OPERATING PROCEDURES (SOPS)
VALIDATION OF BUILDING
Civil Work
Drainage System
VALIDATION OF UTILITY SYSTEMS
Plant Steam
Pure Steam
Water for Injection (WFI)
Compressed Air
Nitrogen (N2)
Heating Ventilation and Air Conditioning (HVAC)
Emergency Power (Standby Generator)
PROCESS DESCRIPTION BUILDING A DRY PRODUCTION: BUILDING A
Process Flow, Variables and Responses: Tablets
Process Flow, Variables and Responses Powder for Suspension
Process Flow, Variables and Responses: Capsules
PROCESS DESCRIPTION LIQUID AND SEMISOLID PRODUCTION: BUILDING B
Process Flow, Variables, and Responses: Syrup, Suspension, and Drop Products
Process Flow, Variables and Responses: Cream Ointment, and Suppository Products
PROCESS DESCRIPTION FOR PARENTERALS PRODUCTION FACILITY: BUILDING C
Process Flow, Variables, and Responses: Aseptic Fill Products
Process Flow, Variables, and Responses: Ready-to-Use Disposable Syringes
Process Flow, Variables, and Responses: Terminal Sterilization Products
Process Flow, Variables and Responses: Lyophilized Products
QUALIFICATION OF PROCESS EQUIPMENT
Commuting Mill
Dryer
V-Shell Blender
Tablet Compression
Capsulation
Powder Filing
Capsule Polisher
Tablet Coating
Syrup Manufacturing Vessel
Suspension Manufacturing Vessel
Drops Manufacturing Vessel
Mixer
Filter Press
Cream/Ointment/Suppository Manufacturing Vessel
Syrup, Suspension, and Drop Filling Machine
Cream and Ointment Filling Machine
Suppository Filling Machine
Labeling Machine
Capping Machine
Cartonator
Shrink-Wrapping Machine
Over-Printing Machine
Autoclave (Steam Sterilizer)
Hot Air Tunnel (Dry Heat Sterilizer)
Vials / Ampoules Washing Machine
Vials / Ampoules / Syringes Filling Machine
Freeze Dyer (Lyophilizer)
Laminar Flow Unit
Pass Through
VALIDATION OF SUPPORT PROCESS
Washing of Components
Sterilization of Components
Depyrogenation of Components
Aseptic Filling Validation (Media Fill Studies)
Cross-Contamination Control
Computerized Pharmaceutical System
QUALITY ASSURANCE / CONTROL LABORATORY VALIDATION
Laboratory Equipment Qualification
Computer Related Systems in QA/QC Laboratory
cGMP PROCEDURES AND PROGRAMS
Engineering Change Control
Calibration
Preventive Maintenance Program
Standard Operating Procedure (SOPs)
Facility Cleaning and Sanitization
Environmental Monitoring Program
HEPA Filter Integrity Testing
Filter Integrity Testing
Label Control Program
cGMP Training
Equipment Log Book, Status Tags, and Room Clearance Checklists
Validation Files
VALIDATION SCHEDULE
DRAWINGS FOR ABC PHARMACEUTICAL PLANT
Index