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 

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 - Quality Assurance Manual of Good Quality Pharmaceuticals Ltd.

INDEX