Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance, 1st Edition (Hardback) book cover

Pharmaceutical Master Validation Plan

The Ultimate Guide to FDA, GMP, and GLP Compliance, 1st Edition

By Syed Imtiaz Haider

CRC Press

208 pages | 17 B/W Illus.

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Hardback: 9781574443301
pub: 2001-12-27
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pub: 2001-12-27
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Description

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.

Table of Contents

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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology