DRUG REGULATORY AFFAIRS & VALIDATION
Rs.191.25
The book Drug Regulatory Affairs and Validation guides analysts, laboratory managers, quality assurance managers, and validation professionals through the validation and qualification process in analytical laboratories. The validation and qualification procedures help to ensure compliance and quality, but with minimal extra cost and administrative complexity. The recommendations are complementary rather than contradictory to any regulations, standards, or official guidelines. They are based mainly on common sense and can be used in cases where information from official guidelines and standards is insufficient for day to day work
Description
- This book addresses international and national regulations and quality standards.
- Its concept, examples, operation procedures and templates are based on my more than twenty years of multinational experience and incorporate all aspects of validation in use at the top companies in these fields.
- Input has been taken from personal discussions with managers, chemists at laboratories, corporate quality assurance managers, quality control managers, and vendors of equipment and chemicals.
- This book will learn how to speed up their validation and qualification processes, to avoiding troublesome costly, reworking, and gaining confidence for audits and inspections.
ISBN: NA YEAR: 2009 EDITION: 2016 BINDING: PAPERBACK PUBLISHER: VPD AUTHOR: KAUSHAL K.CHANDRUL
Related products
-
A TEXTBOOK OF PHARMACEUTICAL TECHNOLOGY-I
The subject pharmaceutical technology-I has been associated with the basis of pharmacy and gives theoretical principles of various topics like semisolid dosage forms, Extraction and galenical products, liquid dosage forms, pharmaceutical Aerosols, Ophthalmic products, and Blood products & plasma substitutes which can be applied in the formulation development of about dosage forms.
A TEXT BOOK OF PHARMACEUTICAL ENGINEERING INCLUIDING UNIT OPERATIONS
The subject of pharmaceutical engineering has been associated with the basis of pharmacy and gives theoretical principles which can be applied in the formulation development of any dosage form. The major objective of writing this book is to present the information in a lucid, condensed and cohesive form, to cater specifically to the needs of undergraduate and graduate students of pharmacy.
MEDICINAL CHEMISTRY VOL-I
Medicinal chemistry has seen enormous growth in the past decade. A huge amount of information is available regarding medicinal chemistry. With Almighty’s grace, the authors feel great pleasure in presenting the “Textbook of Medicinal Chemistry-I” before the readers. Many topics have incorporated with the aim of meeting the needs and interests of graduate and postgraduate pharmacy course according to syllabi of various Indian Universities.
MATHEMATICS & BIOSTATISTICS
The book is designed for undergraduate students of B.Pharma, particularly of the second-year students of B.Pharma of Rajasthan University of health sciences Jaipur.
PHARMACEUTICAL ANALYSIS
Pharmaceutical analysis is one of the major disciplines in pharmacy. Even though several books are available for this subject, we have explained various topics in a simple and lucid way according to the academic needs of pharmacy students, so that students can easily understand the topics and can reproduce in examination maximum effort has been done to present the subject clearly and precisely. We are confident that students of pharmacy will be greatly benefited from this textbook.
PHARMACEUTICAL BIOCHEMISTRY AND CLINICAL PATHOLOGY
The textbook is designed for the undergraduate students of pharmacy, particularly of the first year students RHUS. Materials presented in the book is original. The authors have tried to present the subject from the fundamentals so that the reader can understand the theory and the connected concepts easily.
A TEXT BOOK OF PHARMACEUTICAL MICROBIOLOGY & BIOTECHNOLOGY
The book is a concise review of the pharmaceutically important aspects of microbiology and biotechnology. It covers both the basic and pharmaceutical aspects of bacteriology, immunology, and molecular biology, industrial microbiology, etc. The major objective of writing this book is to present the information in a lucid, condensed and cohesive form, to cater to the needs of undergraduate and graduates students of pharmacy and life science.
A TEXT BOOK OF DISPENSING PHARMACY
The subject Dispensing Pharmacy has been associated with the basis of pharmacy and gives theoretical and practical principles of various topics like posology, prescription, calculation, incompatibility, mixture, lotion, liniments, syrups powders, suspension, emulsion, tablets capsules, ophthalmic products, pastes, creams, jelly and source of information which can be applied in the formulation development of about dosage forms.
