Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

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