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.

Autorentext

Prior to Eurofins, Mr. Pazhayattil held leadership roles with brand name, generic and contract manufacturing organizations. He is an Industrial Pharmacist successful in conceiving, implementing, promoting novel technologies and innovations based on sound scientific principles. His experience extends through solid dose, liquids, small and large volume parenteral dosage forms. Ajay has successfully delivered tangible results in multiple segments of pharmaceutical operations. He has lead successful transfer of Rx and OTC products, managed process development and validation activities for solid dose, liquids and parenteral products. Ajay has lead selection, installation and qualification of equipment's including powder injection lines. He has conducted extensive GMP audits of raw material, formulation, medical device and clinical sites.

He has: developed Process Validation Master Plan based on ICH Lifecycle concept; conceived, developed and implemented a comprehensive PV Lifecycle Management System; established PV Community of Practice to share knowledge; Introduced methodologies for the industry: Pa, # of batch determination, Stage 3A- PCQd, IPV, PaCS Index. He has received multiple Global Recognition Awards. His recent AAPS PharmSciTech journal publications include: 1) Assessment Methodology for Process Validation Lifecycle Stage 3A; 2) A Scientific Approach to Determine number of PPQ batches and 3) Acceptance Probability (Pa) for Process Validation Lifecycle Stages.

Ms. Naheed Sayeed-Desta has more than 17 years of pharmaceutical industry experience and was leading Technical Operations, Process Validation teams at Apotex Inc., prior to leading Sanofi Process Validation team. Naheed was responsible for providing strategic directions on Process Validation Stage 1, 2 and 3 life-cycle management of over 300 molecules. As a global cross site leader, Naheed championed delivery of science and risk based approaches for solid dose products from traditional to novel manufacturing technologies and approaches across the organization. She was the lead author of AAPS PharmSciTech journal article Assessment Methodology for Process Validation Lifecycle Stage 3A. She is a contributing member of PDA Post Approval Change Innovation for Availability of Medicines Program and is involved in developing PDA Technical Report on ICH Q12 tools.

Dr. 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.

Dr. 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 statistics to industrial decision making and the development of machine learning techniques for use in process optimization.

Inhalt
Chapter 1: Lifecycle Approach to Process ValidationProcess Validation StagesAuxiliary Programs Supporting Lifecycle Process ValidationRegulatory Requirements
Chapter 2: Solid Dose FormulationsTabletsTablet Manufacturing ProcessesCapsulesCapsule Manufacturing Process
Chapter 3: Stage 1A Process Design: Quality by DesignQuality Target Product Profile (QTPP)Critical Quality Attributes (CQAs)Critical Material Attributes (CMAs)Critical Process Parameters (CPPs)8Design of Experiments (DoE)Control Strategy (CS)Process Capability and Continual Improvement
Chapter 4: Knowledge Management and Risk Assessment for Lifecycle StagesKnowledge Base for DevelopmentICH Q9 Quality Risk ManagementDesign Space
Chapter 5: Stage 1B Process Scale-Up ConsiderationsProcess Scale-Up StudiesControl Strategy Components
Chapter 6:Stage 2A and Stage 2B: Process QualificationStage 2A- Design and Qualification of the Facility, Equipment andUtilitiesTechnology Transfer ConsiderationsChecklist Prior to Initiating Stage 2BStage 2B- Process Performance Qualification
Chapter 7: Stage 3A and Stage 3B: Continued Process VerificationBenefits of Continued Process Verification ProgramContinued Process Verification Stage 3AContinued Process Verification Stage 3B.ICH Guidance's working in tandem