The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validationlifecycle approach. This set is published as a comprehensive solution for solid dose process validation.

Provides a comprehensive solution for solid dose process validation Discusses approaches for regulatory compliance Details the ICH Lifestyle Approach

Autorentext

Ajay Pazhayattil is an Industrial Pharmacist successful in conceiving, implementing and promoting novel methodologies in Pharmaceutical Quality Assurance, Regulatory Affairs, Technical Operations and Manufacturing Operations based on sound scientific principles. His industry experience extends through solid dose, liquids and parenteral dosage forms. Ajay has been in leadership roles with Eurofins, Apotex, Pharmetics, ANI Pharmaceuticals, Vita Health, Patheon, Emcure and Accord Pharma. He has implemented a comprehensive Life-cycle Management System supporting ICH Q8 to Q12 for global sites. He holds an M. Pharm in Medicinal Chemistry and completed his Doctoral program in business. He has authored multiple Pharmaceutical journal articles. Naheed Sayeed-Desta has extensive experience in formulation, technology transfer and validation providing strategic directions on life-cycle management of small molecules. She is the lead author of several journal articlesand is an active contributor in industry organizations. Naheed earned her BSc. Degree in Biology from Western University and MBA in Management from California Southern University. She currently holds the position of Deputy Director of Validation Services at Sanofi Pasteur in Toronto, Ontario providing leadership in the biopharmaceutical quality sector. Emilija Fredro-Kumbaradzi is Manager of Biowaivers & Biocorrelation team within the Formulation Development Department at Apotex Inc, Toronto responsible for Biopharmaceutical aspects of drug product. She has extensive experience in formulation development of generic formulations for immediate and modified release products intended for various markets. Prior to Apotex, she has held a position of Professor of Pharmaceutical Technology at Faculty of Pharmacy at University of Skopje, Macedonia. She has received her B.Sc. degree in Pharmacy from the University of Skopje, MSc. Degree from the University of Belgrade, Serbia and Ph D. degree in Pharmaceutical Sciences from the University of Skopje, Macedonia. Her current research interests include solid dosage forms of low soluble drugs and various approaches and technologies in drug formulation to remediate solubility and stability issues, Selection of bio indicative dissolution and in silico modelling. Marzena Ingram is a pharmaceutical industry professional with extensive quality assurance and technical operations experience in solid dose and active pharmaceutical ingredients manufacturing operations. She holds senior management position at Eurofins Alphora Research Inc. Prior to Eurofins, Marzena was Senior Manager, Continued Process Verification at Apotex Inc. Ingram developed a specialized Continued Process Verification team and spearheaded the implementation of a product lifecycle program to meet the global regulatory requirements. She has also introduced and published statistically driven product assessment processes. Ms. Ingram has lead implementation of a comprehensive Process Validation life cycle management software solution. Jordan Collins is Senior Solutions Architect at Privacy Analytics, an IQVIA Company, responsible for leading client engagements assessing the risk of re-identification of individuals and supplying guidance on anonymization for data sets shared for secondary purposes. He also currently provides statistical consulting services, primarily to healthcare researchers and pharmaceutical companies. He has extensive experience in performing statistical analyses across a wide variety of industries. Prior to Privacy Analytics, he held the position of Manager, Statistical Support at Apotex Inc. He received his B. Sc. (Honours) degree in Mathematics from Mount Allison University, MSc. degree in Mathematics from McMaster University, M.A. degree in Applied Statistics from York University, and PhD. degree in Philosophy from the University of Auckland, New Zealand. His current research interests include the application of Bayesian

Klappentext

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validationlifecycle approach. This set is published as a comprehensive solution for solid dose process validation.

Inhalt
Preface, Introduction, Chapter 1: Stage 1 Quality by Design Product Development QbD product development methodologies.- Chapter 2: Stage 1 Scale Up, Tech Transfer Process.- Considerations for process scale up and transfer.- Chapter 3: Stage 2 Batch determination, Sampling & Testing Plan.- PPQ batch determination method, scientifically supported sampling and testing plans.- Chapter 4: Stage 3A Continued Process Verification.- Stage 3A assessment methodology for newly launched products.- Chapter 5: Stage 3B Continued Process Verification.- Routine CPV monitoring plan for commercial products.