QA : Manual

Contents: 1. Introduction. 2. Organization. 3. Personnel. 4. Buildings and facilities. 5. Equipment. 6. Production controls. 7. Warehousing. 8. Laboratory controls. 9. Returned goods and reprocessing. 10. Validation. 11. Documentation. 12. Audits. 13. Contract manufacturing. 14. Bulk pharmaceutical chemicals. Annexure A. Index.

From the preface: "While a product may be seen as having magical properties, it is seldom the result of magic. A lot of efforts and resources are required to create a good quality product, appreciated by everybody. This is especially true for pharmaceutical products, about which there is already enough outcry from consumer bodies, especially about pricing. There is only one factor that can shield the pharmaceutical manufacturers from such onslaught and that is to supply good quality products, consistently, to instill confidence in the company by the consumer.

"Quality assurance plays a pivotal role in the production and sale of good quality pharmaceutical products and brings to the company, solid footing of technical prowess and sound management techniques. Having developed such a good foundation, it becomes easy for a company to ensure quality in their products, consistently. In today\'s world of competition and efficiency, the question is not whether one should adopt a quality assurance system or not, but to determine the extent and depth of such a system required to be implemented."