ABSTRACT

The fifth volume in the series, this book covers over-the-counter products, which include formulations of products classified by the US FDA under the OTC category. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered i

part I|32 pages

Regulatory Guidance

chapter 2|10 pages

Solid Oral Dosage Forms

chapter 3|4 pages

Oral Solutions and Suspensions

chapter 4|4 pages

Validation of Cleaning Process

part II|254 pages

Over-the-Counter Product Formulations

part III|24 pages

Appendix