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
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