New Books on Pharmaceutical Quality Assurance

GMP News No. 135

GMP News
1 October 2001

New Books on Pharmaceutical Quality Assurance

Sue Horwood Publishing Limited (SHPL) is a technical imprint serving the pharmaceutical automation, IT and engineering sectors withquick guides and a range of books that address the problems and running of computer systems in the pharmaceutical manufacturing environment.

Members of the European Compliance Academy will getthe following discounts on the books listed below when ordereddirectly from the publisher:
- Individual copy purchases discount is 30% on List Prices below add £2p&p
- Ten copies or more discount is 40% of the UK List add
- Thirty copies and more qualifies for a full 50% discountadd £10 per order
- Corporate concessions are available for company logo editions

Producing a Quality Plan by Tony Simmons is first ina programme of

Pharmaceutical Automation Updates, applicable to all regulatedmanufacturers. It shows how professionals at all levels can learn tocope with the increased dependence on automated systems within allhealthcare related industries such as pharmaceuticals, cosmetics,agrochemicals, food etc.
Recommended by top industry professionals.

ISBN 09540706-0-7

52 pp


Hardcopy/soft cover

Software Management Basics by Keith Baker and TonySimmons, second guide

inthe Pharmaceutical Automation Updates programme, explains softwaremanagement from the beginnings, moving on to explore theimplementation and deployment of software systems, and how they mustbe managed for compliant drug production. Change control,configuration management and test management are among theactivities explained.

ISBN 09540706-1-5

98 pp


Hardcopy/soft cover

Writing the Validation Report by Christopher Clarkreveals a key area of

compliancewithin regulatory requirements for those supplying and usingcomputer systems, in the framework of pharmaceutical manufacturing.Validation reports must be written to satisfy the rigorous demandsof many regulators and Christopher, EMEA at Napp Pharmaceuticals,explains this clearly for all professionals. Computer SystemsValidation Life Cycle series.

ISBN 0-9540706-2-3

due Oct. 2001  50 pp


Hardcopy/soft cover

Preparing the Validation Master Plan by Chris Clark

is an overview of the requirements for planning the GMP computerisedsystems critical for the use of formal Validation Plans, showing howto manage and create these documents. Clarifies the roles andresponsibilities for effective planning in the framework of qualityand compliance. CSV Life Cycle Series

ISBN 1-930114-20-6

37 pp


Hardcopy/soft cover

System Acceptance Test Specification and Testing byDavid Stokes

demonstratesthe value of a careful approach to system acceptance, providingdetailed guidance on the contents of the System Acceptance TestSpecification (SATS). Shows where SATS is placed within the contextof the computer systems validation life cycle with practical adviceon testing methods; a valuable tool for all industry professionalsdealing with IT systems and their validation. Part of the ComputerSystems Validation Life Cycle series.

ISBN 0-9540706-3-1

due Dec. 2001 50 pp



Laboratory Systems Validation Testing and Practiceby Paul Coombes --

engineeringand automation professionals need to be familiar with computerisedlaboratory systems, and similarly engineers who currently work incomputer systems validation or classical engineering validation.This guide speaks their language on best testing practices.

ISBN 0-9540706-4-X

due Dec. 2001 About 100 pp



Suppliers Guide to Computer Validation Audits by GuyWingate

is intended for thoseinvolved in the use and supply of audited computer systems, softwareand related services. Helps both user and supplier to prepare foraudit, not only to complete them efficiently, but also to presentthemselves to regulators in a professional manner. This guide isbased on work conducted with the GAMP Supplier Forum, and defers toGAMP throughout.

ISBN 09540706-5-8

Due Dec. 2001 About 60 pp



The User Requirements Specification by Chris Reidand Barbara Mullendore

takesan interactive approach to the creation of a User RequirementSpecification (URS) and puts this all-important document under themicroscope to provide all the necessary details for developing andimplementing a regulatory compliant URS. Includes timing, templates,requirements ranking, document approvals, format and content,process description and much else. Part of CSV Life Cycle Activities(ed Reid)

ISBN 1-930114-13-3

30 pp



The Functional Design Specification by Chris Reid

The mastermind behind our CSV LifeCycle Activities programme, who has many years' experience in CSVincluding Glaxo Wellcome and Eutech Engineering Solutions (now ABBEutech) is Chris Reid, Director and Senior Consultant of his owncompany, Integrity Solutions Limited of Middlesborough, UK. Heexamines the Functional Design Specification, explaining thedevelopment of a fully traceable specification which can betranslated into the software code and system configuration. Includedhere is GAP analysis, traceability matrix, document approvals andchange control issues.

ISBN 1-930114-27-3

30 pp



Hardware Acceptance Test Specifications and Testingby David Stokes

is a guideto hardware in the CSV life cycle, with detailed guidance to contentof the hardware acceptance test specification and how it related tothe CSV project as a whole. Practical advice on testing in practice,the guide reflects David's many years experience with IT andautomated systems.

ISBN 1-930114-11-7

65 pp



Electronic Records and Electronic SignaturesCompliance

Assessment byChris Reid and Barbara Mullendore provides practical guidance onthe interpretation of 21 CFR Part 11 and the steps you need to taketo address current and future compliance issues. This quick guide isdesigned to help you identify ERES business benefits, establishpolicies, procedures, and processes that ensure compliance, anddefine and evaluate system requirements. Topics covered include:Procedural and administrative controls including details aboutpolicies, training, systems.

ISBN 1-930114-26-5

58 pp


A DHI/PDA publication

A programme of concise clear guides all written by Orlando Lopez,who is Computer Systems Validation Senior Consultant for McNeilConsumer Products at Fort Washington, USA.

21 CFR 11 Compliance Assessment System

Documents the GxP compliance analysis for hybrid, closed systemsbased on the Subpart B in 21 CFR Part 11 – ERES Rule. Theelectronic signature function is separately addressed in the titleabove.

ISBN 1-930114-02-8

14 pp



Spreadsheet Qualification Applications

Examines the test cases to be executed as part of the qualificationof these applications based on final 21 CFR Part 11 ruling, theAmerican Society for Testing and Materials, and current ComputerSystems Validation (CSV) practices.

ISBN 1-930114-06-0

13 pp



Retrospective Validation Plan for Computer-RelatedSystems

Identifies legacy systems to be retrospectively validated,procedures to be followed during associated processes, expectationsfor a retrospective validation of a controlled process. Falls inline with current GMP requirements to help ensure that legacysystems operate correctly.

ISBN 1-930114-05-2

39 pp



Automated Batch Record Systems and QualificationTest Cases

Batch records involvearrangement of discrete control actions, regulatory control actions,sequencing, logic decisions, variable calculations, alarmconditions, and failure modes: as well as instruction on making thebatch product, the batch record documentation records, QA approvals,and product testing. Here Orlando examines the test cases to beexecuted as part of the qualification of an Electronic Batch Record(EBR) system, based on final 21 CFR Part 11 ruling and current CSV.

ISBN 1-930114-03-6

22 pp



Regulatory Systems Hardware Specifications

Step-by-step examination of the approach to qualification ofcomputerised hardware associated with regulatory process controlsystems. An overview that includes computer hardwarecharacteristics, qualification methodology, documentation ofcritical hardware and peripheral components, verification ofsupporting utilities, calibration, wiring, loops, operationalprocedures. Presents the validation project plan and all itscomponents, complete with helpful figures, lists and charts.

ISBN 1-930114-15-X

69 pp



Qualification of Computer Networks

Based on such issues as 21 CFR Part 11, FDA Compliance PolicyGuidelines, and the Draft GAMP SIG "Validation of the ITInfrastructure", Orlando explains qualification of cable mediaand associated hardware/communication software interconnectingautomated systems. Step-by-step guidance is given on a ManufacturingExecution System (MES), including ERP 11, quality management,validation requirements and documents to be adapted or copied.

ISBN 1-930114-0600

36 pp



Qualification of SCADA (Supervisory Control and DataAcquisition) Systems

Following the introduction of 21 CFR Part 11, which establisheddetailed requirements for the qualification of computerised systems,Orlando fills the need for guidance to the Factory Acceptance Testand implementation of SCADA systems.

ISBN 1-930114-04-4

25 pp



Supplier Computer Systems ValidationResponsibilities

This quick guide defines an approach to incorporating softwaresuppliers/integrators early in software projects and effectivelycoordinating project activities to significantly reduce the cost ofvalidation. Timely and clear, the author details the System LifeCycle (SLC) of the software, shows how supplier support is vital toComputer System Validation (CSV), offers Detailed DocumentationChecklist to ensure that all necessary areas are covered. The casereferenced in the guide is for a computer system controlling amanufacturing process.

ISBN to be advised

26 pages



Qualification of Computer Networks

This document describes thequalifications of the cable modem, associated hardware, andcommunication software that interconnect automated systems in apharmaceutical manufacturing environment. It also contains sampledata collection forms to record the installation of a repeater foran Ethernet network system.

ISBN to be advised

35 pages






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