国际制药协会ISPE基础指南05卷;.pdf
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1、 A GUIDE FOR NEW FACILITIES VOLUME 5: COMMISSIONING AND QUALIFICATION EXECUTIVE SUMMARY JUNE 2000 A DOCUMENT DEVELOPED IN PARTNERSHIP BY: ISPE BASELINE GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 2 ISPE BASELINE GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 3 ISPE BASELINE GUIDE COMMISSIONING
2、AND QUALIFICATION JUNE 2000 4 ISPE PHARMACEUTICAL ENGINEERING GUIDE COMMISSIONING AND QUALIFICATION FOREWORD As noted in the Baseline Guides, Volume 1, the pharmaceutical industry has experienced a ratcheting effect in the cost of new facilities. This increase in cost has been driven in part by unce
3、rtainty about the requirements for regulatory compliance. Some significant areas of concern are validation, particularly related to automation systems, and the trend to validate back to source utilities, architectural and HVAC. The absence of a consistent and widely accepted interpretation of regula
4、tory requirements has led to one-upmanship. This practice of building increasingly technically advanced facilities has led to increased cost, longer lead times and, in some cases, delays in bringing new products to market. In May 1994, engineering representatives from the pharmaceutical industry eng
5、aged in a discussion with the International Society for Pharmaceutical Engineering (ISPE) and the Food and Drug Administration (FDA). That first discussion allowed for the creation of 10 facility engineering guides, now known as the Baseline Pharmaceutical Engineering Guides. These guides are intend
6、ed to assist pharmaceutical manufacturers in the design, construction and commissioning of facilities that comply with the requirements of the FDA. Volume 1, covering Bulk Pharmaceutical Chemicals (BPC), was published in June of 1996. This Guide, for Commissioning and Qualification, is the fifth vol
7、ume in the series. As with the BPC Guide, the Commissioning and Qualification Guide, has been sponsored by ISPEs Pharmaceutical Advisory Council, made up of senior pharmaceutical engineering executives from owner companies, the FDA and ISPE senior management. Overall planning, direction and technica
8、l guidance in the preparation of the Commissioning and Qualification Guide was provided by a Steering Committee most of whom were involved in the BPC Guide. The Commissioning and Qualification Guide itself was produced by a task force of around 60 individuals who expended a great deal of their own t
9、ime in its preparation and development. Editors Disclaimer: This guide is meant to assist pharmaceutical manufacturers in the design and construction of new facilities that comply with the requirements of the Food and Drug Administration (FDA). The International Society for Pharmaceutical Engineerin
10、g (ISPE) cannot ensure, and does not warrant, that a facility built in accordance with this guide will be acceptable to FDA. ISPE BASELINE GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 5 ISPE PHARMACEUTICAL ENGINEERING GUIDE COMMISIONING AND QUALIFICATION ACKNOWLEDGEMENTS This guide was developed
11、by an integrated US-European team under the co-leadership of Alan Philips of Pfizer and Christopher Wood of Glaxo Wellcome. The Core Team on the guide was comprised: Alan Philips Pfizer Christopher Wood Glaxo Wellcome Bob Myers Kvaerner Georgia Keresty, Ph.D. Bristol Myers Squibb The Extended Review
12、 Team was comprised the Core Team plus Jan Gustafsson Novo Nordisk Graham Shewell SmithKline Beecham Todd Troutman Kvaerner Simon Shelley Glaxo Wellcome Gene Yuan Hoffman LaRoche The Chapter Credits are as follows: Introduction Alan Philips Georgia Keresty, Ph.D. Pfizer Bristol-Myers Squibb Key Conc
13、epts & Philosophy Chris Wood Georgia Keresty, Ph.D. Glaxo Wellcome Bristol-Myers Squibb Impact Assessment Bob Myers Simon Shelley Todd Troutman Kvaerner Glaxo Wellcome Kvaerner ISPE BASELINE GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 6 Good Engineering Practice John Fadool Graham Shewell Glaxo
14、Wellcome SmithKline Beecham Commissioning Mark E. Miller1 Chris Wood Graham Shewell Genentech Glaxo Wellcome SmithKline Beecham Qualification Practices Jan Gustafsson Gene Yuan Sue Bacso Novo Nordisk Hoffman LaRoche Merck Enhanced Design Review Graham Shewell Chris Wood SmithKline Beecham Glaxo Well
15、come Installation Qualification Bob Myers Bob Adamson Todd Troutman Kvaerner Foster Wheeler Kvaerner Operational Qualification Bob Myers Todd Troutman Kvaerner Kvaerner Performance Qualification Chris Dell Cioppia Kvaerner Related Programs Georgia Keresty, Ph.D. Todd Troutman Bristol-Myers Squibb Kv
16、aerner Illustrative Examples Bob Myers Kvaerner The guide co-team leaders would also like to acknowledge the contributions made by the following part-time members of the guide team: Flemming Steen Jensen (then of) Novo Nordisk Steve Heidel Merck Cecilia Luna Novartis 1 With the support of John Hughe
17、s (TVS Inc,), Jon Sheh (Alza Inc.) and Gary Schoenhouse (Genentech) ISPE BASELINE GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 7 Tony deClaire APDC Consulting FDA Reviewers: We would like to thank the following FDA review team for their input to this guide: Robert Sharpnack Investigator Eric S. W
18、eilage NDA/ANDA Pre-approval Inspection Manager Robert Coleman National Drug Expert, DEIO Brian Nadel Compliance Officer, CDER We also appreciate FDA support from the following representatives: Sharon Smith-Holston Deputy Commissioner for External Affairs Susan Setterberg Regional Director, Mid-Atla
19、ntic Region Joe Phillips Deputy Regional Manager, Mid-Atlantic Region In addition, we would like to acknowledge the support and contribution of the ISPE Technical Documents Steering Committee, in particular the following members: Paul DEramo Committee Chairman, Johnson & Johnson Mel Crichton Eli Lil
20、ly Bruce Davis Astra Zeneca Paul Lorenzo (Retired) ISPE BASELINE GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 8 1. INTRODUCTION 1.1 BACKGROUND The design, construction, commissioning and qualification of manufacturing facilities regulated by FDA or other regulatory authorities pose significant ch
21、allenges to manufacturers, engineering professionals and equipment suppliers. These facilities are required to meet cGMP regulations while remaining in compliance with all other governing codes, laws, and regulations. The cost and time required to bring such facilities on line has been increasing, i
22、n many cases due to inconsistent interpretation of regulatory requirements. The ISPE and engineering representatives from a broad base of healthcare companies (e.g. pharmaceutical, device, biotechnology, etc.) have entered into a partnership with the Food and Drug Administration (FDA) to enhance und
23、erstanding of Baseline cGMP requirements for facilities. This Guide is intended to define key terms and offer a consistent interpretation, while still allowing a flexible and innovative approach to facility design, construction, commissioning and qualification. A fundamental goal of the Guide is to
24、provide value added guidance to industry that will facilitate timely and cost effective commissioning and qualification of facilities. This guide is one in a series of Baseline Guides being planned and produced by ISPE. The majority of these are specific to one functional area (e.g. Oral Solid Dosag
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