Conducting validation processes in the production of medicines according to GMP standards. Methodical recommendations

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The book "Conducting validation processes in the production of medicines according to GMP . standards Guidelines”, written by a team of authors, is an indispensable resource for specialists in the field of pharmaceuticals, as well as for anyone interested in ensuring the quality and safety of medicines . In today’s increasingly demanding manufacturing and quality control market, this edition offers readers a comprehensive approach to process validation that meets international Good Manufacturing Practice (GMP) standards. Process validation is not just a formality, but an important step that ensures that the drugs produced are safe and effective. The book covers key aspects of validation, ranging from design and development to implementation and monitoring, making it relevant for both novice professionals and experienced professionals seeking to update their knowledge. Readers will be able to learn about the various validation methods, their advantages and disadvantages, and how to properly document all stages of the process, which is critical to complying with GMP. standards. This book will be especially useful for undergraduate and graduate students in pharmaceutical and biomedical specialties, as well as for employees of pharmaceutical companies working in the field of quality and validation. It may also be of interest to auditors and inspectors who are engaged in verification of compliance with standards in the production of medicines. It is important to note that process validation is not only a matter of compliance with regulatory requirements, but also a guarantee of trust on the part of consumers and medical specialists. The topics covered in the book cover a wide range of issues, such as risk management, selection of validation methods, development of protocols and reports, as well as approaches to training and staff development. Each chapter contains practical recommendations and examples that make the material accessible and understandable. The authors seek not only to convey theoretical knowledge, but also to show how to put it into practice, which is especially important in the rapidly changing environment of the pharmaceutical industry. The style of the authors is clear and structured, which allows the reader to easily navigate complex issues. The team of authors includes experts with many years of experience in the field of pharmaceuticals, which gives the book additional value. Their previous works have already established themselves as authoritative sources of information, and this publication continues this tradition. The book "Conducting validation processes in the production of medicines according to GMP . standards Methodological recommendations” will become an indispensable assistant for all those who seek to improve the processes of validation and improve the quality of drugs produced. It not only enriches knowledge, but also inspires the application of the knowledge gained in real practice. If you’re looking for validation information in pharmaceuticals, GMP standards, or want to improve the quality of your manufacturing processes, this edition is exactly what you need. Immersing yourself in the pages of this book, you will discover a world where the quality and safety of medicines come first, and process validation becomes an integral part of successful pharmaceutical practice. Don’t miss the opportunity to be a part of this important and responsible process!
LF/402751868/R
Data sheet
- Name of the Author
- Collective of authors
- Language
- Russian
- Release date
- 2017