Over-the-Counter products comprise a special category of healthcare products. While these formulations have much in common with their prescription counterparts, they are presented in this series separately because of their development approach taken, labeling considerations required, and support available from suppliers of ingredients in designing these products.
Highlights from Over-the-Counter Products, Volume Five include:
- solids, liquids, and suspensions
- practical advice on how to bring manufacturing practices into compliance with regulatory requirements
- cGMP considerations in great detail
- a large number of formulations of coatings of solid dosage forms
Table of Contents
REGULATORY GUIDANCE: EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use. EDQM Certification. GMP Audit Template, EU Guidelines. WHO Good Manufacturing Guidelines. Solid Oral Dosage Forms Validation. Current Regulatory Status of Over-the-Counter Products. MANUFACTURING FORMULATIONS: Pharmaceutical Manufacturing Formulations. TABLET COATING FORMULATIONS: Pharmaceutical Manufacturing Formulations.
Niazi, Sarfaraz K.