AN OVERVIEW OF INDUSTRIAL PROCESS VALIDATION OF TABLETS
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paper_title: Pharmaceutics : the science of dosage form design

paper_content:

Design of dosage forms. PART ONE SCIENTIFIC PRINICIPLES OF FORMULATION SCIENCE Solutions and their properties. Rheology and flow. Surface and interfacial phenomena. Solubility and dissolution rate. Disperse systems. Kinetics and product stability. PART TWO PARTICLE SCIENCE AND POWDER TECHNOLOGY Solid-state properties of powders. Particle size analysis. Particle size reduction. Particle size separation. Mixing. Powder flow. PART THREE BIOPHARMACEUTICS PRINCIPLES OF DRUG DELIVERY Introduction to Biopharmaceutics. Factors influencing bioavailability. Assessment of bioavailability. Dosage Regimens. Sustained and extended release. PART FOUR DOSAGE FORM DESIGN AND MANUFACTURE Preformulation. Solutions, Suspensions and Emulsions. Filtration. Powders and granules. Granulation. Drying. Tablets and compaction. Tablet coating. Capsules and encapsulation. Pulmonary drug delivery. Nasal delivery. Rectal and vaginal delivery. Parenteral products. Transdermal drug delivery. Delivery of proteins/biotech products. Packs and packaging. Materials of fabrication and corrosion. Heat transfer and the properties of steam. PART FIVE PHARMACEUTICAL MICROBIOLOGY AND STERILIZATION Fundamentals of microbiology. The action of physical and chemical agents on micro-organisms. Microbiological contamination and preservation. Principles of sterilization. Sterilization practice. Design and operation of clean rooms.
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paper_title: Pharmaceutical process scale-up

paper_content:

Dimensional Analysis and Scale-Up in Theory and Industrial Application Marko Zlokarnik Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era Fernando Muzzio Understanding Scale Up and Quality Risks on the interface between Primary and Secondary Development Frans L. Muller, Kathryn A. Gray, and Graham E. Robinson Scale-up and Process Validation Steven Ostrove Parenteral Drug Scale-Up Igor Gorsky Non-Parenteral Liquids and Semisolids Lawrence H. Block Scale-Up Considerations for Biotechnology-Derived Products Marco A. Cacciuttolo, John Chon, and Greg Zarbis-Papastoitsis Powder Handling James K. Prescott Batch Size Increase in Dry Blending and Mixing Albert W. Alexander and Fernando J. Muzzio Scale Up Of Continuous Blending Aditya U. Vanarase, Yijie Gao, Atul Dubey, Marianthi G. Ierapetritou, and Fernando J. Muzzio Scale-Up in the Field of Granulation and Drying Hans Leuenberger and Gabriele Betz Batch Size Increase in Fluid Bed Granulation Dilip M. Parikh Roller Compaction Scale-Up Ronald Miller Scale-Up of Extrusion and Spheronization Raman Iyer, Harpreet K. Sandhu and Navnit Shah Scale-Up of Compaction and the Tableting Process Matthew P. Mullarney and Jeffrey Moriarty Dimensional Analysis of the Tableting Process Michael Levin and Marko Zlokarnik Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule Formulations Larry Augsburger Scale-Up of the Film-Coating Stuart Porter Virtual scale-up of manufacturing solid dosage forms Hans Leuenberger, Michael N. Leuenberger, and Maxim Puchkov Appendix A: Relevant FDA Guidance for Industry Appendix B: Relevant EU Directives, Regulations, and Gudelines Appendix C: Relevant ICH Documents - International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use Internet link addresses
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paper_title: Pharmaceutical process validation: An overview

paper_content:

AbstractDrugs are critical elements in health care. They must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used. In the pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. It is also a regulatory requirement. This paper presents an introduction and general overview of this process, with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).
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paper_title: Optimization and validation of manufacturing processes

paper_content:

AbstractValidation in the definition adopted by a Joint FIP Committee means that every essential operation in the development, manufacture and control of pharmaceutical products is reliable, reproducible and capable of providing the desired product quality if stipulated production instructions and control procedures are followed.A pre-requisite for, and an integral part of process-validation is that people, premises and equipment should be qualified. In other words, validation activities rely upon the check of technical and physical parameters when measuring devices are being calibrated, equipment is being qualified as well as on chemical, physical and biological parameters when processes are being Validated.As we know, validation starts with planning a new plant, a new machine or equipment as well as with the development of a new or changed product.This way of development from the laboratory trial and the clinical trial until the production phase has to guarentee the manufacture of products conforming to...
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paper_title: Pharmaceutical process validation: An overview

paper_content:

AbstractDrugs are critical elements in health care. They must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used. In the pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. It is also a regulatory requirement. This paper presents an introduction and general overview of this process, with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).
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Title: AN OVERVIEW OF INDUSTRIAL PROCESS VALIDATION OF TABLETS

Section 1: INTRODUCTION
Description 1: Introduce the purpose and importance of tablet manufacturing and the role of process validation in ensuring product quality and consistency.

Section 2: OBJECTIVES OF PROCESS VALIDATION
Description 2: Outline the goals of validating the manufacturing process and ensuring minimal variation in product quality.

Section 3: REASON FOR PROCESS VALIDATION
Description 3: Explain the various reasons for performing process validation, including changes in products, processes, and equipment.

Section 4: TYPES OF PROCESS VALIDATION
Description 4: Describe the four types of process validation: Prospective, Concurrent, Retrospective, and Revalidation.

Section 5: THE REGULATORY BASIS FOR PROCESS VALIDATION
Description 5: Discuss the regulatory history and requirements for process validation as per current good manufacturing practice (cGMP) regulations.

Section 6: STRATEGY FOR INDUSTRIAL PROCESS VALIDATION OF SOLID DOSAGE FORMS
Description 6: Provide strategies for validating solid dosage forms including raw materials, manufacturing conditions, and control variables.

Section 7: GUIDELINES FOR PROCESS VALIDATION OF SOLID DOSAGE FORMS
Description 7: Enumerate the factors to consider when developing and validating solid dosage forms with a broad set of guidelines.

Section 8: PROTOCOL FOR PROCESS VALIDATION
Description 8: Provide detailed steps involved in the protocol for process validation including tables and criteria.

Section 9: STEPS FOR VALIDATION AND ACCEPTANCE CRITERIA
Description 9: Outline the industry steps for validation of tablets, especially focusing on the wet granulation process.

Section 10: INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR TABLETS
Description 10: Discuss the different unit operations needed for tablet manufacturing and the parameters to validate for each operation.

Section 11: ANNUAL PRODUCT REVIEW
Description 11: Explain the importance and process of an Annual Product Quality Review to ensure continuous manufacturing consistency and quality improvement.

Section 12: CONCLUSION
Description 12: Summarize the significance of process validation in ensuring the efficiency and robustness of tablet manufacturing, highlighting regulatory and quality requirements.