BMD-C0023 Copyright © Yokogawa Electric Corporation Oct. 2004 Pharma Handbook 11/24/2004 Yokogawa Electric Corporation Chiaki Shimada Yokogawa United Kingdom

BMD-C0023Copyright © Yokogawa Electric CorporationOct. 2004

Pharma Handbook

11/24/2004

Yokogawa Electric Corporation

Chiaki Shimada

Yokogawa United Kingdom Limited

Roger Halliwell

Yokogawa Confidentia

l

<Confidential>Page.2


Contents

1. Why pharmaceutical?– Market information– Customer Information

2. What’s cGMP?3. What’s GAMP44. Glossary and Acronyms

cGMP : Current Good Manufacturing PracticeGAMP : Good Automated Manufacturing Practice



Why Pharmaceutical?



Why Pharma <Market Size>

Fastest growing process industry

High-level investment in R&D and production facility– Biggest source of new batch plants

http://www.ims-global.com//insight/news_story/0403/news_story_040316.htm



Why Pharma <Market Size by Region>

$14.3B3%$17.4B

4%$37.3B

8%

$52.4B11%

$115.4B25%

$229.5B49%

North America

Europe

Japan

Asia (excluding Japan),Africa and AustraliaLatin America

Rest of Europe

US$ billions

May 2004 www.pharmexec.com

2003 Global Pharma Sales by Region



Why Pharma < Ten key markets, consumer basis>

*Source: IMS Health: MIDAS, MAT Dec 2003

Opportunities especially in:

China+21.8%$6.0B

Japan+3.4%$52.4B

U.S.+11.1%$219.5B

Canada+10.7%$10.0B

Mexico

+1.7%$6.2B

Germany

+8.5%$26.3B

France+6.0%$24.2B

Spain+12.2%$11.7B

Italy+4.5%$16.5B

UK+10.7%$16.4B

10 Key Markets+9.1%

$389.2B



2003 Global Phama Sales – Top 30

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May 2004 www.pharmexec.com

40

30

20

10

US$ bn



Share Trend by Mergers & Acquisitions

1996 Sales

2003 Sales

1 13,027 Glaxo Welcome Pfizer 39,631 1

2 11,617 Merck GlaxoSmithKline 29,817 2

3 9,858 Novartis Merck 22,485 3

4 8,702 Bristol-Myers Squibb Johnson & Johnson 19,500 4

5 8,652 Hoechst Aventis 18,990 5

6 8,463 Roche AstraZeneca 18,849 6

7 8,188 Pfizer Novartis 16,020 7

8 7,924 American Home Products

Bristol-Myers Squibb

14,925 8

9 7,431 Smithkline Beecham Wyeth 12,622 9

10

7,188 Johnson & Johnson Eli Lilly 12,582 10

11

6,516 Pharmacia & Upjohn Abbott Labs 12,325 11

12

6,415 Eli Lilly Roche 12,184 12

13

5,724 Astra Sanofi-Synthelabo 9,102 13

14

5,421 Rohne-Poulenc Boehringer Ingelheim 7,992 14

15

5,202 Takeda Amgen 7,868 15

16

5,049 Schering-Plough Takeda 7,365 16

17

4,784 Bayer Schering-Plough 6,672 17

18

4,101 Sankyo Schering AG 5,460 18

19

3,963 Boehringer Ingelheim Bayer 5,366 19

20

3,928 Abbott Labs Sankyo 3,816 20

Dupont

Warner-Lambert

Zeneca

BASF

Monsanto

SanofiSynthelabo



0 2000 4000 6000 8000 10000 12000

Oil & Gas

Refining

Chemical

Power

Pulp & Paper

Food & Beverage

Pharma

Metals & Mining

Water & Waste

Other

Why Pharma <Annual Growth by Industry>

Total Automation Business for Process Industries by Industry (2002 to 2007)(including Hardware, Software and Services)

2003 RevenuesARC Advisory Group 2003

CAGR

4.4%

4.5%

4.4%

3.7%

3.5%

6.4%

7.8%

4.0%

6.4%

3.2%

M$

20022007

20022007

20022007

20022007

20022007

20022007

20022007

20022007

20022007

20022007



Pharma Company Ranking <Yokogawa Users>< Company> < M US$> USA Europe Others1. Pfizer 39,631 X2. GlaxoSmithKline 29,817 X X (GB) X (Australi

a)3. Merck 22,485 X4. Johnson & Johnson 19,500 X5. Aventis 18,990 X (Germany, France)6. Astra Zeneka 18,849 X (Sweden)7. Novartis 16,020 X8. Bristol-Myers Squibb 14,925 X9. Wyeth 12,62210. Eli Lilly 12,582 X11. Abbott Labs 12,325 X12. Roche 12,184 X (Switzerland)13. Sanofi-Synthelabo 9,10214. Boehringer Ingelheim 7,99215. Amgen 7,868 X16. Takeda 7,365 X (Ireland) X (Japan)17. Schering-Plough 6,672 X X (Singapor

e)18. Schering AG 5,46019. Bayer 5,366 X X (Germany)20. Sankyo 3,816 X (Japan)by ECN1997

Yokogawa

Confidential

X: System UserX: Field, DAQ User



263 systems

０ -

200 -

100 -

300 -

Secondary & Packaging

400 -

500 -

Bulk API

469 systems

Yokogawa Solution on Pharmaceutical Industry

As of Jan.2004



Why Pharma <Market Trends and Opportunities>

Characteristics– High pressure for fast plant construction/start-up

• Block-buster profit model requires “speed to market”

– Regulation-compliance• Validation services outsourced

• Validation services can be larger than system & configuration costs

– Customers generally conservative when selecting vendors• Hesitation to user a first-time vendor

• Vendor market presence & reputation is important for selection

Entry barrier is high, but once entered, long-term partnership is the norm

Emerging trends– FDA Guidance (Sept. 2003) limits legacy Part 11 coverage

• Fewer existing systems will be upgraded

– Fine chemical companies are moving into bulk pharma business• New pharma accounts are emerging who are already familiar with Yokogawa

Threat

Opportunity!



Why Pharma <Competition>


Corporate problems at Invensys

ABB is still strong position with pharma skid

Emerson DeltaV Batch is #1 Competition– Strong mind-share, Vertical capabilities

Siemens is strong in plant wide integration

Revenues505.6M$

5.8 4.22.4

12.9%

14.8%

19.5%

19.8%

20.6%

Invensys

ABB

Honeywell

Emerson

SiemensYokogawa

Yamatake

Others

Market shares of the PAS suppliers (Pharma)



Why Pharma <Competition>

MES is becoming the main battlefield for differentiationMarket shares of the CPM Software & Services suppliers (Pharmaceutical Industry)(CPM: Collaborative Production Management)

25.3%

25.1%14.5%

9.0%

7.6%

5.6%

3.2%1.7%3.4%

4.5%HoneywellABBRockwellAspenTechYamatakeInvensysSiemensYokogawaWerumOSIsoft

Revenues200.4M$




What’s our goal?



0 20 40 60 80 100 120

Invensys

ABB

Honeywell

Emerson

Siemens

Yokogawa

Yamatake

Others

What we want to achieve <Final Goal>

2001 Total $505.6MYokogawa: 5.8%, $29M

20.6%

19.8%

19.5%

14.8%

12.9%

5.8%

(M$)

*Source: 2002 ARC 2001 Market Shares of the PAS Suppliers

2001 Total Revenue = $505.6 Million

2007 ： Total $644M Yokogawa: 7.0%, $45M

Market shares of the PAS suppliers (Pharma)

Our goal in 2010 15 % share (over $100M)

7% 15%



How we are going to do it <Strategy>

Basic approach– Focus on specific target segments for penetration

• Bulk chemical companies • Chemical companies moving into bulk pharma• Pharma machine companies

– Secure repeat business• Cultivate local accounts• Secure steady revenue stream from modification jobs

– Batch applications typically require constant modifications - a good source for repeat orders



Marketing Process & Deliverables

The sales funnel

After sales commitment

P.O. !

Attract– Advertisement

• Industry ads, solution ads

– Direct Marketing• Promo CD

– Public Relations• News releases, magazine articles, success

stories

– Events• Industry shows, industry conferences

– Web• Industry web pagesInteract

–Sales tools•Internal handbooks•Bulletins•White papers •Tier3•Reference lists

–Demos

Retain–Project execution & lifecycle support

•Engineering KM network

Network–User groups

•Periodic meeting, e-Update



Schedule

7 8 9 10 11 12 1 2 3 4 5 6

2004 2005

Ads

Direct MktgPublic Rela

Event

Sales Tools

Web

Demos

Rollout

InterPhexAsia, US

Tier3 Slide

Enhance

Ads

Strategy

Kickoff

InterPhexAsia, US

Task Force



JapanUSAEurope

ASEAN

Pharma Task Force & Networking Team

Constantine Lau

Chiaki Shimada

John van der Geer

Sng Hee Meng

Dave EmersonYHQ: C.Shimada,N.Kousaka, N.Togami

YCA: C.Lau, B.Jensen, D.Emerson, B.Quigley, D.Cathey

YEA: S.Meng, J.Tan, E.Yau, N.Chuan, S.Kuan, J.Lee

YEF: J.Geer, A.Voogd, B.Mohring, R.Halliwell, I.Pichler, P.Carrington, G.Kalis, F.Schleapfer,

YSA: A.Perreira, J.Natalino, M.Figueira, M.Sanatana

YTW: A.Chen

Pharma Networking

Arthur Voogd,Roger Halliwell

Bruce Jensen



Summary

• Vision: 15 % share in Pharma Market by 2010

• Strong pursuit of pharma projects in your sales opportunities with our differentiators

• Develop product/system opportunities from services business, vice versa

• Enhance vertical industry marketing, developing knowledge base & delivering new collaterals

Be aggressive in Pharma industry with:Be aggressive in Pharma industry with:



What’s cGMP ?



Basis for Understanding: 1990’s

What is cGMP?current Good Manufacturing Practice - around 1991, the FDA began the adoption of cGMP to signify the latest understanding of the validation practices and standards expected by the regulatory authorities.

Brought about as a result of several hogh profile cases (mostly in Europe) where manufacturers had products banned in the US for non-compliance.

Part of Food, Drug, and Cosmetic Act 21CFR200, parts 210, 211




FDA EnforcementThe FDA inspects firms for compliance with cGMP, and can take enforcement actions when deviations are found

Form 483 - Discrepancies found by inspector

EIR - Establishment Inspection Report, Details of 483, basis for further action

Notice of Adverse Findings - Official notice to inspected firm that they are in violation of cGMP, further action will be taken if not corrected

Regulatory Letter - Initiates corrections

Sanctions may include: Seizure, Prosecution, Injunction, Civil Penalties

Which can lead to: Criminal Prosecution, Cease and Desist Orders




ResponsibilitiesTHE FDA DOES NOT VALIDATE, the end user is responsible for validation. The FDA conducts inspections of computer systems’ user-generated validation documentsation. The goal is zero discrepancies or adverse findings.

Vendors can be held liable, however (CPG 7132a.12)

Vendors provide, evidence that project execution procedures (design, development, testing, changecontrol, are followed - “validatable”

If a system “passes”, this is no guarantee that there will be no findings the next time - validation guidelines and philosophy change over time.

Sanctions may include: Seizure, Prosecution, Injunction, Civil Penalties

Which can lead to: Criminal Prosecution, Cease and Desist Orders



Summarized Understanding

Common theme’s for Validation:• life-cycle approach• quality management• procedures• training• validation protocols• qualification evidence• change control• audit trail• on-going evaluation

“GMP Documentation Requirements for Automated Systems” R.F. Tetzlaff (1992) Parts 1,2,3 Pharmaceutical Technology

“Computerized Systems and GMP - A UK Perspective” A.J. Trill (1993) Parts 1,2,3 Pharmaceutical Technology International



General Validation Activities

PLANNING

SPECIFICATION

TEST PLANNING

IQOQPQ

TESTINGIQOQPQ

REVIEW and REPORT

Prepare written Validation Plan

Specify & agree what is required. Perform Design Reviews

Prepare document to describe how the equipment/system is to be tested

Perform test and collect results

Review results to show that system performs as specified, report conclusions, plus any reservations

IQ : Installation QualificationOQ: Operational QualificationPQ: Performance Qualification



What’s GAMP4 ?



GAMP 4

What is GAMP 4?What is GAMP 4?

Who would use GAMP 4?Who would use GAMP 4?

GAMP 4 (Good Automated Manufacturing Practice) is a comprehensive set of guidelines to be followed in order to enable prospective validation of an automated system.

GAMP 4 (Good Automated Manufacturing Practice) is a comprehensive set of guidelines to be followed in order to enable prospective validation of an automated system.

Both end users and suppliers alike.Both end users and suppliers alike.

What type of automated systems can GAMP 4 be applied to?What type of automated systems can GAMP 4 be applied to?

Typical examples are DCS, PLC, SCADA, MES, LIMS.Typical examples are DCS, PLC, SCADA, MES, LIMS.



GAMP 4

Who produces GAMP 4?Who produces GAMP 4?

Why were the GAMP guidelines produced?Why were the GAMP guidelines produced?

GAMP 4 is produced by the GAMP Forum a technical subcommittee of the ISPE (International Society of Pharmaceutical Engineering).

GAMP 4 is produced by the GAMP Forum a technical subcommittee of the ISPE (International Society of Pharmaceutical Engineering).

Due to the increased complexity and increased scrutiny of automated systems together with the interpretation of the relevant regulations.

Due to the increased complexity and increased scrutiny of automated systems together with the interpretation of the relevant regulations.

Who is in the GAMP Forum Subcommittee?Who is in the GAMP Forum Subcommittee?

Representatives from both major pharmaceutical companies and suppliers. Representatives from both major pharmaceutical companies and suppliers.



GAMP 4

Why does Yokogawa recommend the use of GAMP 4?Why does Yokogawa recommend the use of GAMP 4?

Are there any other reasons for using GAMP 4?Are there any other reasons for using GAMP 4?

Because GAMP 4 provides a logical and thorough framework to produce all the necessary documentation and procedures required for the validation of automated systems in the pharmaceutical industry.

Because GAMP 4 provides a logical and thorough framework to produce all the necessary documentation and procedures required for the validation of automated systems in the pharmaceutical industry.

Yes, if the GAMP 4 methods and procedures are followed it is much more likely that a system will be provided on time, within budget and to the required specification.

Yes, if the GAMP 4 methods and procedures are followed it is much more likely that a system will be provided on time, within budget and to the required specification.



GAMP 4

Do the FDA advocate the use of GAMP 4?Do the FDA advocate the use of GAMP 4?

Although the FDA are an independent body it is widely accepted that the use of GAMP 4 is a highly respected method of providing computer system validation.

Although the FDA are an independent body it is widely accepted that the use of GAMP 4 is a highly respected method of providing computer system validation.

Do the pharmaceuticals companies advocate the use of GAMP 4?Do the pharmaceuticals companies advocate the use of GAMP 4?

Yes.Yes.



GAMP 4

Does GAMP 4 advocate a System Life Cycle approach?Does GAMP 4 advocate a System Life Cycle approach?

Yes.Yes.



GAMP 4

What is in GAMP 4 ?What is in GAMP 4 ?

GAMP 4 is split into the following 4 main sections.

• Main Body

• Management Appendices

• Development Appendices

• Operational Appendices

GAMP 4 is split into the following 4 main sections.

• Main Body

• Management Appendices

• Development Appendices

• Operational Appendices



GAMP 4

What is in the Main Body?What is in the Main Body?

The Main Body provides an overview to the guide, describes the principles behind validation together with a glossary of validation terms.

The Main Body provides an overview to the guide, describes the principles behind validation together with a glossary of validation terms.



GAMP 4

What is in the Management Appendices?What is in the Management Appendices?

The Management Appendices provide the procedures by which a project is managed. The Management Appendices provide the procedures by which a project is managed.

End UserEnd User

SupplierSupplier

End UserEnd User

SupplierSupplier

SupplierSupplier

SupplierSupplier

SupplierSupplier

SupplierSupplierSupplierSupplier

End User and SupplierEnd User and Supplier



GAMP 4

What is in the Development Appendices?What is in the Development Appendices?

End UserEnd User

SupplierSupplier

SupplierSupplier

SupplierSupplier

SupplierSupplier

The Development Appendices provide the procedures for producing the design and test specifications for the system.

The Development Appendices provide the procedures for producing the design and test specifications for the system.

SupplierSupplier



GAMP 4

What is in the Operation Appendices?What is in the Operation Appendices?

The Operation Appendices provide the procedures for operating the system.The Operation Appendices provide the procedures for operating the system.

End UserEnd User

SupplierSupplier

End UserEnd User

End UserEnd User

End UserEnd User

End UserEnd User

End UserEnd User

End UserEnd User



Glossary and Acronyms



Glossary [A] extracted from Gamp4

Acceptance Criteria (IEEE)The criteria that a system or component must satisfy in order to be accepted by a user, customer or other authorized entity ．

Acceptance Test (IEEE)Testing conducted to determine whether or not a system satisfies its acceptance criteria and to enable the customer to determine whether or not to accept the system ． See also Factory Acceptance Test (FAT), Site Acceptance Test (SAT).

Application Software (ISO)Software or program that is specific to the solution of an application problem

Audit (ISO)Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.

Bespoke System (GAMP)A system produced for a customer, specifically to order, to meet a defined set of user requirements. Also called Custom Built System.

Business Continuity Planning (BS 7799-2:1998 Information security management. Specifications for information security management systems)A managed process for developing and maintaining cross-organizational plans to counteract interruptions to business activities.



Glossary [C] extracted from Gamp4

Calibration (ISO 10012)The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values of a quantity realized by a reference standard.

Change Control (PDA)A formal process by which qualified representatives from appropriate disciplines review proposed or actual changes to a computer system. The main objective is to document the changes and ensure that the system is maintained in a state of control.

Commercial Off the Shelf Software (IEEE)Software defined by a market-driven need, commercially available, and whose fitness for use has been demonstrated by a broad spectrum of commercial users. Also know as COTS.

Computer (ISO)A functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention.

Computer System (IEEE)A system containing one or more computers and associated software.



Glossary [C] extracted from Gamp4

Customer (ISO)Organization or person that receives a product. See also User.

Design (IEEE) (1), ISO (2)(1) The process of defining the architecture, components, interfaces, and other characteristics ofa system or component. (2) Set of processes that transforms requirements into specified characteristics or into the specification of a product, process or system.

Factory Acceptance Test (FAT), (IEEE)An Acceptance Test in the Supplier's factory, usually involving the Customer. See also Acceptance Test. Contrast to Site Acceptance Test.

Functional Testing (IEEE)Testing that ignores the internal mechanism of a system or component and focuses solely on the outputs generated in response to selected inputs and execution conditions. Also known as black-box testing.

Installation Qualification (PDA)Documented verification that a system is installed according to written and pre-approved specifications.

Key Practices (PDA)Processes essential for computer validation that consist of tools, work flow and people.



Glossary [N] extracted from Gamp4

Network (FDA) (1) (ISO) (2)(1) An arrangement of nodes and interconnecting branches. (2) A system [transmission channels and supporting hardware and software] that connects several remotely located computers via telecommunications.

Operating Environment (GAMP)All outside influences that interface with the computer system.

Operational Qualification (PDA)Documented verification that a system operates according to written and pre-approved specifications throughout all specified operating ranges.

Performance Qualification (PDA)Documented verification that a system is capable of performing or controlling the activities of the processes it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment.

Periodic Review (PDA)A documented assessment of the documentation, procedures, records, and performance of a computer system to determine whether it is still in a validated state and what actions, if any, are necessary to restore its validated state. The frequency of review is dependent upon the systems complexity, criticality, and rate of change.



Glossary [P] extracted from Gamp4

Process (ISO)A set of interrelated or interacting activities which transform inputs into outputs.

Process Parameter (PDA)A variable that defines or controls a process and can affect the outputs.

Process Validation (FDA)Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.

Product (PDA) (1), (ISO) (2)(1) The intended result of activities or processes, (2) Result of a process

Programming Standards (FDA)Written procedures describing coding [programming] style conventions specifying rules governing the use of individual constructs provided by the programming language, and naming, formatting, and documentation requirements which prevent programming errors, control complexity and promote understandability of the source code.

Qualification (ISO)The process to demonstrate the ability to fulfil specified requirements.



Glossary [Q] extracted from Gamp4

Quality Management System (ISO)Management system to direct and control an organization with regard to quality.

Quality Plan (ISO)Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract.

Record Retention (ISO)Storing and retaining quality records in an established and recorded period of time in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Records may be in the form of any type of media, such as hard copy or electronic media.

Requirement (IEEE)(1, 2), (ISO) (3)A condition or capability needed by a user to solve a problem or achieve an objective. (2) A condition or capability that must be met or possessed by a system or system component to satisfy a contract, standard, specification, or other formally imposed documents. (3) Need or expectation that is stated, generally implied or obligatory.



Glossary [R] extracted from Gamp4

Review (ISO)Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives.

Security (GAMP)The protection of computer hardware and software from accidental or malicious access, use, modification, destruction, or disclosure. Security also pertains to personnel, data, communications, and the physical protection of computer installations.

Site Acceptance Test (SAT). (IEEE)An Acceptance Test at the Customer's site, usually involving the Customer. See also Acceptance Test, contrast to Factory Acceptance Test.

Source Code (FDA) (1) (IEEE) (2)Computer instructions and data definitions expressed in a form suitable for input to an assembler, compiler or other translator. (2) The human readable version of the list of instructions [program] that cause a computer to perform a task.



Glossary [S] extracted from Gamp4

Specification (IEEE)A document that specifies, in a complete, precise, verifiable manner, the requirements, design, behavior, or other characteristics of a system or component, and often, the procedures for determining whether these provisions have been satisfied.

Structural Testing (Bluhm, Meyers, Hetzel) (GAMP)Examining the internal structure of the source code. Includes low-level and high-level code review, path analysis, auditing of programming procedures, and standards actually used, inspection for extraneous "dead code", boundary analysis and other techniques. Requires specific computer science and programming expertise. Also known as white-box testing.

Supplier (ISO)Organisation or person that provides a product.

Supplier Management (GAMP)The ongoing process of evaluating a supplier against established quality standards, managing noted deficiencies, and working with the supplier to improve the quality of its products or services and documentation.

System (PDA)(1) (ISO)(2)(1) Equipment, procedures, and other resources required to perform or control a process. (2) Set of interrelated or interacting elements.



Glossary [S] extracted from Gamp4

System Life Cycle (IEEE)The period of time that begins when a system is conceived and ends when the system is no longer available for use.

System Qualification (based on ISO)The process to demonstrate that a system has the ability to fulfill specified requirements.

Test (IEEE) (1) (ISO)(2)(1) An activity in which a system or component is executed under specified conditions, the results are observed or recorded, and an evaluation is made of some aspect of the system or component (2) Determination of one or more characteristics according to a procedure.

Test Case (IEEE)A set of test inputs, execution conditions, and expected results developed for a particular objective, such as to exercise a particular program path or to verify compliance with a specific requirement.

Test Plan (IEEE)A document describing the scope, approach, resources, and schedule of intended test activities. It identifies test items, the features to be tested, the testing tasks, who will do each task, and any risks requiring contingency planning.



Glossary [T] extracted from Gamp4

Test Procedure (IEEE)Detailed instructions for the set-up, execution, and evaluation of results for a given test case.

Traceability (ISO)Ability to trace the history, application or location of that which is under consideration.

User (GAMP)The person, or persons, who operate or interact directly with the system. The User(s) and the Customer(s) are often not the same person(s), but may be. See also Customer.

User Requirement Specification (URS) (GAMP)A requirement specification that describes what the equipment or system is supposed to do, thus containing at least a set of criteria or conditions that have to be met.

Validation (FDA)Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.



Glossary [V] extracted from Gamp4

Validation Plan (PDA)A document which describes the overall strategy and responsible parties for validating a system within its operating environment.

Verification (ISO)Confirmation, through the provision of objective evidence that specified requirements have been fulfilled



Acronyms extracted from Gamp4 and Validation of Process Control Systems

API Active Pharmaceutical IngredientASCII American Standard Code for Information InterchangeCAT Critical Assessment TeamCFR Code of Federal RegulationsCRT Cathode Ray TubeDCS Distributed Control SystemEBRS Electronic Batch Record SystemEMI/RFI Electromagnetic Interference/Radio Frequency InterferenceER/ES Electronic Record / Electronic SignatureFAT Factory Acceptance TestingFDA Food and Drug AdministrationFS Functional SpecificationGAMP Good Automated Manufacturing PracticeGC Gas ChromatographyGCP Good Clinical PracticeGDP Good Distribution PracticeGEP Good Engineering PracticeGLP Good Laboratory PracticeGMP Good Manufacturing PracticeGxP Good x Practice, where x one of: ・ Clinical ・ Distribution ・ Laboratory ManufacturingHAT Hardware Acceptance Testing

Back



Acronyms extracted from Gamp4 and Validation of Process Control Systems

HDS Hardware Design SpecificationHPLC High Performance Liquid ChromatographyHVAC Heating, Ventilation, and Air ConditioningIAMS Instrument Asset Management SystemIQ Installation QualificationOQ Operational QualificationPCS Process Control SystemPDA Personal Digital AssistantP&ID Process and Instrument Diagrams / Piping and Instrumentation DiagramsPLC Programmable Logic ControllerPQ Performance QualificationQA Quality AssuranceQMS Quality Management SystemSAT Site Acceptance TestingSCADA Supervision, Control, and Data AcquisitionSDS Software Design SpecificationSLA Service Level AgreementSOP Standard Operating ProcedureURS User Requirement SpecificationVMP Validation Master PlanVP Validation PlanVPCS Validation of Process Control SystemsVR Validation Report

Documents

BMD-C0023 Copyright © Yokogawa Electric Corporation Oct. 2004 Pharma Handbook 11/24/2004 Yokogawa Electric Corporation Chiaki Shimada Yokogawa United Kingdom