QA Manual

EDITOR: D. H. Shah
PUBLISHER: Business Horizons
ISBN: 9788190078825
YEAR: 2000 – First Edition, 2002, 2007 - Reprinted
PAGES: 302
SIZE: 18.5 X 24 X 2 cm.
BINDING: Hard
LANGUAGE: English

ABOUT THE BOOK: Launching for the first time ever, the most comprehensive and detailed guide to management of Quality Assurance in pharmaceutical production facilities.
It includes
    • Facility Design
    • Equipment
    • Production Controls
    • Bulk Pharmaceutical Chemicals
    • Laboratory Controls
    • Personnel
    • Validation
    • Documentation
    • Audits
A manufacturer must, in designing, making and marketing a medicine, satisfy the regulatory authorities and himself that his products are of adequate quality, safety and efficacy. Application of the principles of quality assurance and of good manufacturing surveillance, all contribute to the assurance of quality. The purpose of this book therefore is to provide an instant knowledge-base of such systems and procedures which will help a pharmaceutical manufacturer to comply with most countries legislation’s with regard to quality assurance and cGMP requirements.

ABOUT THE EDITOR: D. H. Shah graduated in pharmacy in 1962 and has been associated with the manufacture of all categories of drug formulations for over 30 years. He is presently technical director in some of the reputed pharmaceutical companies in India and is actively involved in quality assurance and cGMP compliance activities as per international requirements.

CONTENTS:
PREFACE
INTRODUCTION
    General
    Case for Pharmaceutical Industry
    ISO 9000 Quality Management System
    Perception of Quality
    Quality Assurance in the Next Millennium
ORGANIZATION
    Structure
    Functions
    Quality Manual
    Site Master File
PERSONNEL
    Qualifications
    Responsibilities
    Hygiene
    Training
BUILDING AND FACILITIES
    Design and Construction Features
    Lighting
    Air Handling System
    Plumbing
    Sewage and Refuse
    Washing and toilet Facilities
    Sanitation
    Maintenance
EQUIPMENT
    Equipment Construction
    Equipment Cleaning and Maintenance
    Validation of the Cleaning
    Cleaning Schedule
    Maintenance
    Computer Systems Validation
    Calibration
PRODUCTION CONTROLS
    Written Procedures
    Change Control
    Contamination Control
    Sterile Products
    Aseptic Process Control
    Packaging
WAREHOUSING
    Design
    Prevention of Cross Contamination
    Good Warehousing Practices
    Storage
    Dispensing
    Weighing
LABORATORY CONTROLS
    Specification
    Raw Materials
    Packaging Materials
    In-Process Quality Control
    Reserve Samples
RETURNED GOODS AND REPROCESSING
    Returned Goods
    Product Recall
    Reprocessing
    Rejects/Scrap Disposal
VALIDATION
    Applicability
    Analytical Test Procedures
    Instruments Equipment Design, Installation and Operation
    Facility Design, Installation and Operation
    Utility Design, Installation and Operation
    Manufacturing Process
    Product Development
DOCUMENTATION
    General Requirements
    Equipment Cleaning and Use Records
    Packaging and Labelling Records
    Master Production Record
    Batch Manufacturing Record
    Material Identification
    Review of Records
    Laboratory Records
    Distribution Records
    Complaint Files
AUDITS
    Internal or External Audits
    GMP Audits
CONTRACT MANUFACTURING
    Contract
    Commercial Discussions
    Confidentiality Agreements
    Technical Agreements
    Regulatory Aspects
    Validation
    Deviations and Change Control
    Re-Assessment of Principal Manufacturer
    Contract Analysis
BULK PHARMACEUTICAL CHEMICALS
    Personnel and Training
    Premises and Facilities
    Plant and Equipment
    Documentation
    Validation
    Impurity Profile
    Change control
    Material Management
    Raw Materials
    Containers, Filling and Labelling
    Engineering
    Quality Assurance and Quality Control
    Recovery, Reprocessing and Returns
    Storage Life and Stability Testing
    Complaints and Recalls
    Retention Periods
ANNEXTURE A
INDEX