- Quality Assurance
- Computer Systems Validation
- Batch Processes
- Drug Delivery to the Oral Cavity
- Encyclopedia of Pharmaceutical Technology, Third Edition
- FDA Regulatory Affairs
- HVAC Fundamentals
- Biopharmaceutics
- Biotechnology
- Cosmeticology
- Dispensing Pharmacy
- Microbiology
- Novel Drug Delivery System
- Packaging Technology
- Pharmaceutical Engineering
- Pharmaceutical Excipients
- Pharmaceutics
- Physical Pharmacy
- Preformulation
- Question & Answers on Safety
Discover essential pharma books covering GMP, quality assurance, production, validation, regulatory affairs and audits worldwide. This collection is designed for students, beginners and experienced professionals who want clear, practical guidance instead of vague theory. From basic principles of dosage form design to advanced quality systems, each book focuses on real-world pharmaceutical challenges, typical inspection findings and proven industry best practices.
You’ll find titles dedicated to Good Manufacturing Practices (GMP) that explain layout, documentation, qualification, validation and shop-floor controls with examples and checklists. Quality Assurance and Quality Control books cover deviation handling, CAPA, change control, OOS/OOT results, data integrity and internal audits in a simple, stepwise manner. For those working in production, there are detailed references on solid dosage, liquids, sterile manufacturing, aseptic practices, environmental monitoring and equipment operation, supported by flowcharts, tables and troubleshooting tips.
The validation section includes practical guides on process validation, cleaning validation, analytical method validation, equipment qualification and computerized system validation, aligned with current regulatory expectations. Regulatory affairs books help you understand global guidelines (WHO, EU, USFDA and others), dossier preparation, lifecycle management and responses to authority queries. Dedicated books on GMP audits and inspections show how to prepare for audits, manage auditors, handle observations and build a culture of continuous improvement.