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Three Decades of Drug Regulation and Legislation
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Jill Wechsler
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The US Food and Drug Administration has pursued many new initiatives since 1977. The agency began accepting abbreviated applications for generic versions of drugs, collected user fees to support drug review, launched the Critical Path Initiative to encourage innovation, and worked to harmonize its regulatory standards with those of Europe and Japan. New challenges such as AIDS and bioterrorism have affected regulatory policy in recent years. The author reviews FDA's changes in policy and philosophy during the past 30 years.
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The Evolution of FDA's Role in Ensuring Product Quality
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| By
Rakhi B. Shah
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Mansoor A. Khan
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The quality of a drug product is an essential element of drug safety and efficacy. With a statutory mission to provide safe and effective medications to the public, the US Food and Drug Administration has always focused on drug quality. The authors summarize the history of FDA's role in ensuring product quality and its role in shaping risk-based approaches to this goal.
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A New Manufacturing Framework
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Maribel Rios
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As a well-known and well-respected researcher, director, and speaker Fernando Muzzio shares his insights into the significant steps that have led to the "unprecedented" manufacturing industry of today.
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Charting Process Improvement in Sterile Product Manufacturing
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James E. Akers
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Sterile product manufacturing and related testing have evolved significantly during the last 30 years. From requirements for acceptance criteria for media-fill tests, to developing validated approaches for moist-heat sterilization, to the introduction of formalized sterility-testing practices, the pharmaceutical industry has made significant advances in testing and in key technology such as isolators, prefilled syringes, automation, and robotics. The author outlines the key regulatory and technical changes to sterile product manufacturing and takes a visionary look for the next era of sterile manufacturing marked by a greater emphasis on risk analysis.
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A Look at 30 Years of Change in Pharmaceutical Automation
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Bob Lenich
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Christie Deitz
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Automation took hold gradually in the life-science industry. Its adoption brought the industry innovations and improved efficiency. Recent years witnessed the emergence of batch-automation systems and the development of standards for automation. The authors discuss the major changes automation brought to the industry and examine the rapid pace of technological development.
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A Perspective on Computer Validation
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Rory Budihandojo
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Steve Coates
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Ludwig Huber
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Jose E. Matos
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Siegfried Schmitt
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David Stokes
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Graham Tinsley
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Maribel Rios
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This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.
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Contaminated LVPs and the Origins of Validation
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William Garvey
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Fundamental validation skills related to heating, ventilation, and air conditioning must be thoroughly understood. Knowing the early history and development of validation is essential to understand the current set of regulations and standards governing the industry. This article reviews the history and outcome of contamination in large-volume parenteral drug products and discusses the qualification requirements of modern HVAC systems.
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Innovations Enable Packaging to Play Many Roles
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Hallie Forcinio
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Drug packaging performs functions such as ensuring patient well-being, providing information, preventing tampering, blocking counterfeiting, and improving compliance. Since 1977, packaging innovations have occurred in four major categories. The author provides an overview of major packaging improvements that have emerged in the past 30 years.
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Improving Routes in API Manufacturing
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Patricia Van Arnum
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Catalytic routes to producing atorvastatin and sitagliptin are recent advancements.
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Injectable Administration Systems
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Frances DeGrazio
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During the past 30 years, manufacturers developed sophisticated packaging and delivery systems to support the requirements of traditional and complex biologics, including quality and cleanliness. This article discusses the evolution of packaging and delivery systems for injectable administration systems as the pharmaceutical and biotechnology industry evolved during the past 30 years. It also explores the future of packaging and delivery systems as technology and drug development advance.
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Statistical Implications of the CGMPs: A 30-Year Retrospective
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Lynn D. Torbeck
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This article looks at the current good manufacturing practice regulations from a statistical perspective while addressing their requirements and implications and inviting the industry to assess its past performance in meeting the regulations.
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30 Years of Pharmaceutical Technology and What Lies Ahead
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A review of advancements in areas such as active ingredients, formulation, technology, regulation, and analytical testing.
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