Call for Chapters: Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry

Editors

Eugenia Gabriela Carrillo Cedillo, Universidad Autónoma de Baja California, Mexico
Karina Arredondo-Soto, Universidad Autónoma de Baja California, Mexico
Kenia Palomino Vizcaino, Universidad Autónoma de Baja California, Mexico
Héctor Magaña Badilla, Universidad Autónoma de Baja California, Mexico

Call for Chapters

Proposals Submission Deadline: October 18, 2021
Full Chapters Due: November 18, 2021

Introduction

Quality control in pharmaceutical products and medical devices is vital for users, they must comply with national and international regulations. Quality control (QC), refers to all the procedures and testing undertaken to ensure the identity and purity of pharmaceutical products. It plays a significant role in pharmaceutical production and control. QC is basically the checking or testing so that specifications can be met. Quality control is a part of good manufacturing practice(s) (GMP) which is concerned with sampling, specifications and testing, until their quality has been judged to be satisfactory. Quality control testing involves repetitive testing of samples of active pharmaceutical ingredient (APIs) or of pharmaceutical products. These guidelines WHO provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained. Pharmaceutical quality control testing is usually a matter of repetitive testing of samples of APIs or of a limited number of pharmaceutical products, whereas national quality control laboratories have to be able to deal with a much wider range of pharmaceutical substances and products and, therefore, have to apply a wider variety of test methods. Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. A medical Device is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of: a) Diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap and, b) Investigation, replacement or modification of the anatomy or of a physiological process. Quality control in the pharmaceutical and medical industry is essential to guarantee products that comply with public health prevention. For this reason, the manufacture of a quality product will minimize patient safety.

Objective

The general objective of this book is to make known the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients. The comparison of the analytical results of the samples must represent the finished product. Reinforce and update the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices today. Specific objectives are: • Give the reader an overview of the leading quality control tests for raw materials and products in the pharmaceutical industry, adhering to current regulations. • Give the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations. Benefits: • It will strengthen the knowledge of students, engineers, supervisors, pharmacists, chemists, professionals, academics, and researchers about quality control in the pharmaceutical and medical industry. • Clarify the importance of regulatory monitoring in the manufacturing process and its impact on health. This book will impact two critical industries in the health area, such as pharmaceuticals and medical devices. It will strengthen the knowledge of the personnel assigned to these industries, and the academy will be able to identify areas of opportunity to collaborate and link with them. Undergraduate and graduate students will increase their knowledge and identify areas of opportunity and specialization.

Target Audience

The target audience will be composed of professionals, managers, engineers, supervisors, pharmacists, chemists, academics, researchers, and students working in the medical devices and pharmaceutical industry; specifically, the target audience includes all the personal related to de quality control and manufacturing of drugs and medical devices.

Recommended Topics

• Pharmaceutical research • Manufacture of medical products • Uniformity and content • Weight control • Traceability • Critical process parameters • Critical control points • Improvement in the quality control of the medical industry • Validation and calibration • Analytical method validation • Manufacturing according to sanitary registration • Bioequivalence • Good manufacturing practices • Advanced Materials • Microbiological Quality Control • Disinfection, cleansing and Sterilization • Case studies and worked examples

Submission Procedure

Researchers and practitioners are invited to submit on or before October 18, 2021, a chapter proposal of 1,000 to 2,000 words clearly explaining the mission and concerns of his or her proposed chapter. Authors will be notified by October 19, 2021 about the status of their proposals and sent chapter guidelines.Full chapters are expected to be submitted by November 18, 2021, and all interested authors must consult the guidelines for manuscript submissions at https://www.igi-global.com/publish/contributor-resources/before-you-write/ prior to submission. All submitted chapters will be reviewed on a double-blind review basis. Contributors may also be requested to serve as reviewers for this project.

Note: There are no submission or acceptance fees for manuscripts submitted to this book publication, Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry. All manuscripts are accepted based on a double-blind peer review editorial process.

All proposals should be submitted through the eEditorial Discovery® online submission manager.



Publisher

This book is scheduled to be published by IGI Global (formerly Idea Group Inc.), an international academic publisher of the "Information Science Reference" (formerly Idea Group Reference), "Medical Information Science Reference," "Business Science Reference," and "Engineering Science Reference" imprints. IGI Global specializes in publishing reference books, scholarly journals, and electronic databases featuring academic research on a variety of innovative topic areas including, but not limited to, education, social science, medicine and healthcare, business and management, information science and technology, engineering, public administration, library and information science, media and communication studies, and environmental science. For additional information regarding the publisher, please visit https://www.igi-global.com. This publication is anticipated to be released in 2022.



Important Dates

October 18, 2021: Proposal Submission Deadline
October 19, 2021: Notification of Acceptance
November 18, 2021: Full Chapter Submission
December 2, 2021: Review Results Returned
December 16, 2021: Final Acceptance Notification
December 28, 2021: Final Chapter Submission



Inquiries

Eugenia Gabriela Carrillo Cedillo
Universidad Autónoma de Baja California
gaby@uabc.edu.mx

Karina Arredondo-Soto
Universidad Autónoma de Baja California
karina.arredondo@uabc.edu.mx

Kenia Palomino Vizcaino
Universidad Autónoma de Baja California
kenia.palomino@uabc.edu.mx

Héctor Magaña Badilla
Universidad Autónoma de Baja California
hector.magana@uabc.edu.mx



Classifications


Medical, Healthcare, and Life Sciences; Science and Engineering
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