- Gmp Inspections: Basics for Beginners:
This book introduces the subject of Good Manufacturing and Compliance for Regulated Industries in approximately 400 pages (Medical devices, pharmaceuticals, and Biotechnology). The first chapter goes through the fundamentals of GMP, including how it applies to people, equipment, materials, and processes. The chapters that follow outline the major themes and areas that emerge throughout the various industries or specialties. While many GMP criteria apply to all medical and therapeutic products, audits and GMP inspections in specific areas involve specific demands and reference points.
2. cGMP Current Good Manufacturing Practices
cGMP Current Good Manufacturing Practices book content:
- Personnel, and Surroundings.
- Buildings, and Facilities.
- Equipment or instruments.
- Materials Management.
- Quality Management.
- Manufacturing Operations, and Control.
- Documentation and Records.
- Pharmaceutical Validation.
- Post-Operational Activities.
- Sterile Pharmaceutical Products.
- Site, and Plant Security Safety and Environmental Protection.
- Good Pharmaceutical Wholesaling Practice.
- Pharmaceutical Audits, An Overview of Quality by Design.
3. Compliance Remediation for Pharmaceutical Manufacturing:
Book related to pharmaceutical compliance, data, and generate reports to fill the gap between manufacturer and regulatory agencies.
This system is the gold standard for leading regulatory compliance activities, and its successful implementation will provide a foundation for the company’s profitability.
There are FDA reference documents included.
4. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing:
Contributions from top international specialists in risk management and drug production are featured in Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. These contributions are based on the most recent research, best practices, and industry standards, as well as the writers’ own personal experiences. The book can be used for the following purposes:
- Principles, strategies, and applications of risk management at a basic level.
- Tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes that have been tested and proven.
- Risk management in pharmaceutical manufacturing is now governed by FDA guidelines, EU regulations, and international norms.
- Case studies provide detailed examples demonstrate the application of risk management principles to drug product manufacturing and the results obtained.
- Bibliography contains extensive references to the literature as well as useful field resources.
5. Equipment Qualification in the Pharmaceutical Industry
The Pharmaceutical Industry’s Equipment Qualification gives guidance and fundamental information for preparing a quality qualification program. It has been noticed that there is a common lack of understanding in the sector about what makes a compliance qualification program, particularly among individuals new to the industry. Even skilled people have faced a sense of insecurity when it comes to obtaining a compliant state. The installation (IQ), operational (OQ), and performance (PQ) protocols are all covered in this book as well as the design and implementation of qualification protocols. It goes through the significance of relevant qualification courses.
e.g.,(Quality systems, commissioning, computer systems, and cleaning) and how to merge them into a completely compliant qualification procedure. It also includes matrices that show what should be included in each type of protocol for the most common types of process equipment. Students and pharmaceutical scientists can use Equipment Qualification in the Pharmaceutical Industry as a guide for preparing and executing qualification (installation, operational, and performance) protocols.
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