QA Manual

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


CONTENTS

Preface

INTRODUCTIONGeneral 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