About the Book

One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required.

This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States.

The CD-ROM contains 74 template validation standard operating procedures that can be tailored to meet the regulatory compliance requirements of any pharmaceutical, diagnostic, medical device, medical equipment, and biotech product. You can edit, print, and customize these procedures to fit your needs. The book and CD work together to minimize the number of documents used and to ensure their accuracy. All critical elements and requirements of validation are covered, so you can easily implement them and avoid the stress that usually accompanies an FDA audit.

Features

Provides all the information that managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines

Includes step-by-step directions for translating GMP requirements into action, based on your company's Master Validation Plan and execution protocols

Describes how to establish test functions and prevent defects in order to produce products that are fit for use

Serves as an ideal companion to Haider's Pharmaceutical Master Validation Plan

Table of Contents:
VAL 100.00
Introduction to Validation
VAL 200.00
Fundamentals of Validation SOPs
Validation Master Plan and Guideline for DQ, IQ, QQ, and PQ
Design Qualification Guideline for Minimizing the Risk of Product Cross-Contamination by Air Handling System
Design Qualification Guideline for Minimizing the Risk of Cross-Contamination of Facility, Equipment, and Process
Design Qualification Guideline for HVAC System of a Pharmaceutical Plant
Design Qualification for the Prevention of Contamination of Non-Sterile Pharmaceutical Products
Design Qualification Guideline for Cross-Contamination and Decontamination
Design Specifications for Process Water
Design Specifications for Water for Injection Production and Distribution
Design Specifications for Purified Water (DIW) Production and Distribution
Design Specification for Pure Steam Production and Distribution
VAL 300.00
Validation Glossary
Organization for Validation
Revalidation
Retrospective Validation
Validation Change Control
VAL 400.00
Calibration of Instruments
Periodic Review of the Calibration Program
Calibration and Validation Equipment
VAL 500.00
Training on the Job
Good Manufacturing Practices
VAL 600.00
Guidelines for Area Classification and Air Handling
Guideline for Area Validation: Clean Area
Aseptic Area Validation Procedures
Microbiological Monitoring of Areas Used for Production of Solids, Semi-Solids, and Liquids
Efficiency Testing for Disinfectants
Drinking Water
Purified Water
Water for Injection
Validation of a Water System
Oil-Free Compressed Air System
Nitrogen Distribution System
Clean Steam
Vacuum System
Validation of an HVAC System
VAL 700.00
Validation of a Steam Sterilizer
Hot Air Sterilization Tunnel Certification and Validation Guideline
Freeze Drier
Ampule and Vial Washing Machine
Washing, Sterilizing, and Drying Machine for Stoppers
Ampule and Vial Filling Machine
Media Fill Run
Half-Automatic Inspection Machine
Ampule Crack Detection Machine
Laminar Flow Installations
Sterile Filtration Validation
Cleaning Efficiency of Production Equipment for Parenterals
VAL 800.00
Kneading Machine
Oscillating Granulator
Milling Machine
Fluid Bed Drier
Blender
Tablet Press
Metal Check Device for Tablets
Tablet Coater
VAL 900.00
Blistering Machine
Blister Filling Machine
Code Reader
Sachetting Machine
Cartoning Machine
Labeling Machine
Check Weigher
Shrink Wrapping and Bundling Machine
Tube Filling and Closing Machine
Liquid Filling and Closing Machine
Tablet Filling and Closing Machine
VAL 1000.00
Installation Qualification of Computerized Equipment
Operational Qualification of Computerized Equipment
Performance Qualification of Computerized Equipment
VAL 1100.00
Validation of Microbiological Methods
Validation of Analytical Methods
VAL 1200.00
Vendor Certification
VAL 1300.00
Facility Qualification
Recommended Reading