Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance's, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

First publication to address process validation and the lifecycle process Essential information for pharmaceutical professional who use process lifecycle validation Addresses the need for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance

Autorentext
Dr. Ajay Babu Pazhayattil, Pharmaceutical Consultant, Toronto, Canada Dr. Ajay Babu Pazhayattil is a highly experienced pharmaceutical professional with a strong background in industrial pharmacy and executive management. He has a track record of driving innovation for brand, generic, and CDMO pharmaceutical organizations. He is known for his data-driven, regulatory-compliant approach to formulation and is well-respected in the industry. He is actively involved in industry organizations and is recognized as a thought leader in the field, having made significant contributions through published journal articles and textbooks. Sanjay Sharma, Senior Vice President & Head Manufacturing Science and Technology, Zydus Sanjay is a seasoned pharmaceutical industry professional with over 23 years of experience in the development, launch, and maintenance of drug supply. He possesses a results-driven approach and a deep understanding of pharmaceutical manufacturing science, which has enabled him to contribute to the success of some of the largest organizations in the industry. Sanjay has held various leadership positions in Indian and multinational pharmaceutical companies such as Cipla, Dr. Reddy's Laboratories, Sandoz, Watson, Torrent, and Lupin. Joe Paul Philip, Joe Paul Philip, Vice President & Head, Global Process Excellence and New Products, Glenmark Pharmaceuticals Joe Paul Philip has over 20 years of experience in Technical and Strategic Leadership roles, specifically in Life Cycle Management of Formulations. He has experience leading multicultural teams globally and expertise in Process Development, New Product Launches, Technical Services, R&D Technology Transfers, Global Technology Transfers, Process Validations, Computer System Validations, Equipment Qualifications, Technical Investigation, Root Cause Analysis, and Data Analytics for OSD, Parenteral & Semi-solid technology platforms. He also has experience and knowledge in negotiating development/commercial agreements. Michelle Gischewski-Silva, Scientific Advisor, Eurofins Alphora, Alphora Research Inc As a highly experienced and accomplished leader in the pharmaceutical industry, Michelle brings a wealth of knowledge and expertise to her role. With a solid background in critical new product development projects, she possesses deep technical knowledge in R&D formulation development, scale-up, process validation, and technology transfer of solid and liquid dosages. As the head of the formulation, she was responsible for optimizing formulations and streamlining processes to ensure robustness. Marzena Ingram, Senior Consultant, Validant Inc. Marzena Ingram is an experienced independent senior pharmaceutical consultant who specializes in quality and technical operations for solid-dose and active pharmaceutical ingredient manufacturing. She helps clients address FDA warning letter scenarios. She has developed a specialized team for continued process verification. She has also implemented programs to meet global regulatory requirements, developed and published statistical tools for pharmaceutical manufacturing processes, and led the implementation of a comprehensive life cycle management software. Marzena is a board member of ISPE Canada.

Inhalt

Volume One.Preface.- Lifestyle Approach to Validation.- Solid Dose Formulations.- Stage 1A Process Design: Quality by Design.- Knowledge Management and Risk Assessment for Lifestyle Stages.- .Stage 1B Process and Scale Up Considerations.- Stage 2A and 2B Process Qualifications.- Stage 3A and 3B: Continued Process Verification.