By Guy Wingate
ISBN-10: 0849318718
ISBN-13: 9780849318719
Either pervasive and ubiquitous, automatic structures at the moment are an imperative element of each company process in pharmaceutical and healthcare businesses. even though, while expertise is mixed with high-risk public defense tasks or the creation and keep watch over of life-saving medicinal drugs or units, it will be important to make sure that it really is trustworthy, caliber guaranteed, and proven. the main complete consultant on machine validation presently to be had, containing greater than two hundred illustrations and greater than a hundred tables, computers Validation is helping you spot the massive picture.The writer stories laws and their improvement, association duties, validation lifestyles cycle in response to GAMP4 advisor, strategic ways to validation, digital documents and signatures, dealing with regulatory inspections, metrics, and possibilities for functionality development. He offers functional examples and checklists through the ebook and explores the function of caliber coverage and danger administration as key elements of pragmatic regulatory compliance. overlaying equipment that assist you stay away from duplicating attempt between departments and company services, the publication demonstrates how one can use your funding in know-how to enhance enterprise potency and achieve the aggressive area.
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Extra resources for Computer systems validation: quality assurance, risk management and regulatory compliance for pharmaceutical and healthcare companies
Example text
2. M. (2000), On Time, Within Budget: Software Project Management Practices and Techniques, Third Edition, John Wiley & Sons, New York. 3. S. (1997), Validating Automated Manufacturing and Laboratory Applications: Putting Principles into Practice, Interpharm Press, Buffalo Grove, NY. 4. European Union (2002), Guide to Good Manufacturing Practice for EU Directive 2001/83/EC, Community Code Relating to Medicinal Products for Human Use, Volume 4. 5. The Institute of Chartered Accountants in England and Wales (1999), Internal Control: Guidance for Directors on the Combined Code, ISBN 1-84152-010-1.
3 expecting too much too soon. A degree of self-discipline is required because short-cutting the quality process will almost certainly wreak havoc later on. 4, adopting good practices will progressively engineer out the bad practices and deliver measurable cost benefits. Projects conducted without an underpinning quality management system have a variable and unpredictable success rate. As such, quality management needs to address the well-worn issues of: • • • • • • • • • • • • Requirements misunderstanding Scope creep Development risk Quality of software of unknown pedigree Uncontrolled change Design errors Too much or too little documentation Project progress reporting and action planning Resource inadequacy Regulatory inspection readiness Ease of system operation and maintenance Planning ahead for retirement and decommissioning GXP PHILOSOPHY Pharmaceutical and healthcare regulations require the adoption of quality practices.
Code of Federal Regulations Title 21, Parts 210 and 211; and Medicinal Products — Part 1 of the Australian Code of Good Manufacturing for Therapeutic Goods. GMP is enforced on the ground by the national regulatory authorities. S. K. Medicines and Healthcare products Regulatory Authority (MHRA), and the Australian Therapeutic Goods Administration (TGA). The regulatory authorities can prevent the sale of any product in their respective country if they consider its manufacture non-GxP compliant. To pharmaceutical and healthcare companies, GxP is nothing less than a license-to-operate matter.
Computer systems validation: quality assurance, risk management and regulatory compliance for pharmaceutical and healthcare companies by Guy Wingate
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