is pe baseline guide brochure

7/23/2019 Is Pe Baseline Guide Brochure

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FOR NEW AND RENOVATED FACILITIES

www.ISPE.org/publications

Featuring... Active Pharmaceutical Ingredients

Biopharmaceutical Manufacturing Facilities

Commissioning and QualificationWater and Steam Systems

Sterile Manufacturing Facilities

New! Oral Solid Dosage Forms, Second EditionDetails on Page 6!

Plus...What’s Coming in 2010



ISPE Baseline® Guides2

Introduction to ISPE Baseline® Guide

What is a Baseline® Guide?ISPE’s Baseline® Guides are a series of industry guidesdeveloped in partnership with the US Food and Drug

Administration (FDA). Each volume in the series is acollaborative effort of global industry leaders representing a

broad cross-section of manufacturers and other industryexperts. The Guides document current industry practice forfacilities and systems used for production ofpharmaceutical products. They are intended to:

• Establish a baseline approach to new and renovatedfacility design, construction, commissioning, andqualification which is based upon clear understanding ofthe type of product and its manufacturing process

• Prioritize facility design features based upon the impacton product and process

• Avoid unnecessary spending on facility features that do

not contribute to consistent production of quality products

It is important to understand that these guides are notregulatory documents. Where non-engineering issues arecovered, the information is included to highlight theimportance of such topics and the impact they have onfacility design. Therefore, non-engineering topics are notcovered comprehensively and specific advice from Quality

Assurance Departments should be sought where additionalinformation is required. The Guide principles also may be applied to existingfacilities as they are upgraded or modernized.

Baseline® Guides Objectives • Reduce cost of producing pharmaceutical products while

maintaining or improving product quality and consistency

• Provide consistent guidance for design and constructionof manufacturing facilities regulated by the FDA and otherglobal regulatory authorities

• Help prevent misinterpretation of regulations that governmanufacturing operations

The Baseline® ApproachThe Baseline® approach identifies features of the facility,

which may affect the ability to reliably and consistentlyproduce quality pharmaceutical products. Features areprioritized to focus on those that are most critical tothe production of safe and reliable products. Investmentcapital and manpower can then be allocated mostproductively through intelligent selection of simple andeffective systems.

Alternative DesignsThe Baseline® Guides address the concept of alternative designsThis aspect of the Guides is critical because it enables them tobe adapted to the corporate characteristics of each manufacturerWhere appropriate, Baseline® Guides identify advantages and

disadvantages of design alternatives and provide information tohelp assess benefits. Alternatives can then be reviewed basedupon economics, historical data, and other factors, to select anapproach consistent with the manufacturer’s product andcorporate characteristics. Manufacturers may elect to construct simpler, less capitalintensive facilities, and utilize procedural controls to maintainquality, or may invest more capital to construct highly automatedoperations and rely less on operational procedures to assureproduct quality. The Guides provide background to accommodate the approach,which best fits the specific manufacturer and the needs and

economics of a specific product and site location.

How the Baseline® Guides RelateCurrent Guides are listed below and the relationship between theGuides is shown in Figure 1.

The Guides are categorized as:

1. Vertical Guides that address specific types of productmanufacturing operations

2. Horizontal Guides that address common supportsystems and functions such as pharmaceutical water or

facility commissioning and qualificationGuides that focus on manufacturing operations (Vertical Guides)include brief sections introducing concepts that are covered indetail in Horizontal Guides.



* Nonmember fee includes membership in ISPE. See order form for details.

ISPE Baseline® Guides

Active Pharmaceutical Ingredients, A Revision of Bulk Pharmaceutical Chemicals

The first revision in the Baseline® Guide series incorporates new regulations and guidance,such as ICH Q7, ICH Q9, GAMP® 4, 21 CFR Part 11, Guidance for Industry, Sterile Drug

Products Produced by Aseptic Processing – Current Good Manufacturing Practice (cGMP),FDA Draft Guidance for Industry PAT – Framework for Innovative PharmaceuticalManufacturing and Quality Assurance, and much more.

Key Features of the Guide include:

Active Pharmaceutical•Ingredient Characterization

Process Analytical•Technologies

Good Engineering Practice•Levels of Protection

Potential Contamination• Critical Process Parameter • Critical Instruments•

Critical Unit Operation• Contamination Review• Design Qualification•

Critical Process Steps• Direct, Indirect, and No•Impact Systems

Critical and Non-Critical•Components

Facility Designation• Intended Patient Use• Process Review•

Risk to Patient• Understanding of Process•

Developed by an integrated US-European Team, this Guide incorporates global industrycomments representing Canada, Denmark, France, India, Japan, UK, and the USA. Inaddition, API underwent extensive regulatory review with input from global regulatory agencie

With the purchase of the API Guide, you will also receive a white paper, Briefly Exposed (BrieOpen), by Stan Newberger and Dr. Trish Melton. This white paper expands and clarifies a neconcept introduced in the Guide. This new concept, Briefly Exposed, allows manufacturersanother degree of freedom in operations. They will be able to briefly open their processes forvarious reasons (sampling, adding ingredients, other) for short time periods and under certaincircumstances and to apply the most appropriate levels of protection (Level I, II, or III) basedon risk-mitigation. An assessment of the risk to the API and ultimately to the patient is anappropriate method for manufacturers to establish what those circumstances are.

Recommended Levels of Protection (API Baseline Guide; Figure 2.9)

Item #: API0607ISBN: 1-931879-55-9

Pricing:Member $200/ €145 Nonmember* $415/ €345

88 pages; released February 2007




* Nonmember fee includes membership in ISPE. See order form for details.ISPE Baseline® Guides4

Biopharmaceutical Manufacturing Facilities

This Guide is a reference for design, construction, commissioning, and qualification of newfacilities for biopharmaceutical Active Pharmaceutical Ingredients (APIs), also known as drugsubstance. The Guide covers in-line process analytical measurement and control, the useof disposable equipment, enhanced strategies for automation, and alternative methods forprotecting the integrity of the product. Produced by Task Teams, composed of more than 100regulatory and industry leaders, the Guide addresses US GMPs, while the GMPs of othercountries and regions are covered in the appendices.

Bound Version Bound Version plus Electronic VersionItem #: BIO0604 Item #: BIOELECISBN: 1-931879-09-5 ISBN: 1-931879-11-7

Pricing: Pricing:Member $200/ €145 Member $340/ €250Nonmember* $415/ €345 Nonmember* $555/ €450

196 pages; released July 2004

Commissioning and QualificationThis Guide focuses on engineering approaches and practices for timely, cost-effectivedelivery of manufacturing facilities, specifically addressing the process of designing,constructing, commissioning, and qualifying the facilities, utilities, and equipment

regulated by the FDA or other health authorities. The Guide has incorporatedcomments from industry representatives, FDA field investigators, and personnel from theFDA’s Center for Drug Evaluation and Research (CDER). The Guide is intendedprimarily for regulatory compliance in the US market, and it may be helpful to manufacturersfor meeting European requirements.

Bound Version Bound Version plus Electronic VersionItem #: CQ0101 Item #: CQELECISBN: 1-931879-06-0 ISBN: 1-931879-08-7


142 pages; released March 2001

Published ISPE Baseline® Guides



* Nonmember fee includes membership in ISPE. See order form for details. ISPE Baseline® Guides 5

Water and Steam SystemsThis Guide focuses on engineering issues and cost-effective solutions for the design,construction, and operation of pharmaceutical water and steam systems. It covers design ofsystems for feed water quality, pre-treatment and final treatment, storage and distribution,and operation/maintenance procedures. The Guide is intended primarily for regulatorycompliance in the US market. Issues relating to Europe are discussed in the Guide’sappendix.

Bound Version Bound Version plus Electronic VersionItem #: WAT0101 Item #: WATELECISBN: 1-931879-03-6 ISBN: 1-931879-05-2


228 pages; released January 2001

Sterile Manufacturing FacilitiesThis Guide addresses the design, construction, commissioning, and qualification of new orrenovated sterile manufacturing facilities, covering facilities for both aseptic processing andterminal sterilization of formulated products, generally for parenteral use. It is applicable to

formulations that use active ingredients devised from either conventional chemistry orbiopharmaceutical processing. The Guide is intended primarily for regulatory compliance inthe US market, and it also may be helpful to manufacturers for meeting Europeanrequirements.

Item #: STER0199ISBN: 1-931879-02-8

Pricing:Member $200/ €145 Nonmember* $415/ €345

166 pages; released January 1999




* Nonmember fee includes membership in ISPE. See order form for details.ISPE Baseline® Guides6

Oral Solid Dosage Forms, Second EditionThis revision — the latest ISPE publication reviewed by the US FDA — updates contentfrom the original Oral Solid Dosage Forms Baseline® Guide to current industry standards,practices, and regulatory requirements.

Specifically, it addresses the latest interpretation of GMP requirements, as well as a risk-based approach to regulatory compliance relating to the design, construction, and validationof the OSD manufacturing facility. The product and processing chapter has been expandedwith detailed discussion of each critical unit operation and new technological trends, suchas continuous processing and implementation of process analytical technology. The Guideprovides a comprehensive view of best practices available in the pharmaceutical industryfor oral solid manufacturing facility design and construction. A lifecycle approach to projectmanagement is emphasized.

Item #: OSD1109ISBN: 1-931879-67-2

Pricing:Member $200/ €145

Nonmember* $415/ €345

188 pages; released November 2009

Other ISPE Technical Resources:

ISPE Knowledge BriefsIn effort to address the industry’s need for current, relevant, and useful content, ISPE hasdeveloped concise, problem-solving documents called Knowledge Briefs. These tools are easy-to-read resources that help industry professionals get up-to-speed quickly on contemporarypharmaceutical industry topics.

Knowledge Briefs are intended to provide an overview of a discipline-specific subject.Knowledge Briefs are presented in several levels ranging from Basic to Advanced. The contextand relevance of the subject can be easily understood and implemented into day-to-day jobfunctions. Each brief includes links to additional ISPE resources such as technical documents,Pharmaceutical Engineering articles, Communities of Practice, and educational seminars toprovide more specific and detailed information on the subject.

Knowledge Briefs are available for immediate download at www.ISPE.org/publications

Pricing:Member FREE Nonmember $5/ €3




ISPE Baseline® Guides 7

Science and Risk-Based Approach for theDelivery of Facilities, Systems, andEquipment

This Guide considers the principles and activitiesassociated with implementing a science and risk-basedapproach, such as that outlined in ICH Q9 and ASTM E2500-07. These principles and activities constitute an efficient andacceptable approach to demonstrating facility and equipmentfitness for use as required by major globalregulatory authorities.

This Guide is designed to improve the way in which theindustry delivers regulated manufacturing capacity by:

• Improving the ability to meet documented processrequirements

• Controlling risks within the manufacturing process• Producing high quality products• Consistent operation to meet product user requirements It is acknowledged, that many organizations have eistingpolicies and procedures developed around the principles andpractices of the First Edition of Volume 5 of the ISPEBaseline® Guide: Commissioning and Qualification. Inaddition to setting out the principles of the new approach,this Guide provides additional materials in the appendicesthat discuss options on how to adapt those existing policiesand procedures to embrace the new Science and Risk-basedapproach.

Risk-Based Manufacture of ActivePharmaceutical Products (Risk-MaPP)

The Risk-MaPP Guide will provide a framework for a risk-basedapproach to manufacturing active pharmaceutical products. It will

address how risk characterization and risk assessment can be usedto develop limits for the Allowable Daily Intake (ADI), OccupationalExposure Limit (OEL), and cleaning validation limits for both productand non-product contact surfaces.

This Guide is intended to be used by industry for the planning,design, construction, commissioning, and qualification of new ornewly-renovated systems/processes/facilities that are regulatedglobally by such agencies as the FDA, EMEA, and MHLW.

Quality Laboratory Facilities

The Quality Laboratory Facilities Guide will present design

guidance focused on quality laboratories within or part of the cGMPenvironment. Quality laboratories range widely across a variety offunctions, testing platforms, and types. The role of these laboratoriesis quality assurance, not research. Their mission is to develop thetests necessary and to execute on-going implementationguaranteeing the quality, integrity, and stability of the product and itscomponents at each stage of the manufacturing process, and to testthrough a variety of diagnostic methods assuring product conformityto design and performance as defined by the SOPs prior to release.

The Guide will provide a baseline for the design of qualitylaboratories supporting regulated facilities producing product forhuman consumption; assist in the interpretations of function,operation, or design for quality laboratories within the cGMPenvironment; instill and guide consistency in the baseline design andperformance of quality laboratories; and design of qualitylaboratories for cost reduction when producing pharmaceuticalproducts for human consumption.

ISPE Baseline® Guides - What’s Coming in 2010



ISPE Baseline® Guides Order Form

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