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Sterile Product Facility Design and Project Management

By: Jeffrey N. Odum

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Hardcover | 29 March 2004 | Edition Number 2

At a Glance

Hardcover
390 Pages

Edition Type
New edition

Dimensions(cm)
23.4 x 15.6 x 2.59

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$1,052.80

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Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices.

Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered.

Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager''s viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

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You Can Find This Book In

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Pharmacology

Introduction to facility project management	p. 1
Project management	p. 1
Project philosophy	p. 3
Planning	p. 3
People	p. 5
Control	p. 6
Contracting	p. 6
References	p. 8
Project formation	p. 9
Conceptual development	p. 9
Functional objectives	p. 10
Schedule objectives	p. 11
Budget objectives	p. 12
Organizing	p. 16
Team selection	p. 17
Project charter	p. 19
Roles and responsibilities	p. 20
Alignment	p. 20
Project alternatives	p. 22
Analyzing technology	p. 23
Project management	p. 24
Site evaluation	p. 24
Conceptual scope and estimate	p. 27
Scope definition	p. 28
Conceptual estimate	p. 28
Evaluation	p. 30
Project definition	p. 31
Risk analysis	p. 31
Execution approach	p. 34
Project control guidelines	p. 34
Defining the project team	p. 37
The owner's team	p. 37
Approach	p. 38
Selecting the architectural and engineering firm	p. 38
When	p. 38
How	p. 39
Preparing the request for proposal	p. 40
Proposal review	p. 43
Selection criteria	p. 46
Technical qualifications	p. 46
Management qualifications	p. 47
The subtleties	p. 48
Selecting the construction contractor	p. 48
Engineer/procure/construct (EPC)	p. 49
General contractor	p. 49
Construction management	p. 50
Selection process	p. 50
Facility programming	p. 53
First step	p. 53
The process	p. 54
Gathering data	p. 54
Steps	p. 55
Space requirements	p. 59
Quality of construction	p. 63
Budget	p. 64
Time	p. 64
Path forward	p. 65
Types of information	p. 65
Function	p. 65
Form	p. 65
Economy	p. 66
Time	p. 68
Communication	p. 69
Results	p. 69
References	p. 71
Project control	p. 73
Basic elements	p. 73
Plan the work, work the plan	p. 74
Work breakdown structure	p. 75
Estimating	p. 76
Preliminary estimates	p. 77
Detailed estimates	p. 78
Estimate development	p. 79
Factored estimates	p. 80
Analysis of factored estimates--Rules of thumb	p. 82
Estimate trending	p. 84
Contingency development and management	p. 85
Schedule	p. 87
Schedule development and evaluation	p. 87
Summary schedules	p. 87
Activity breakdown	p. 89
Long lead-time activities	p. 89
Sequencing	p. 91
Activity durations	p. 92
Cash flow	p. 94
Project completion	p. 95
Mechanical completion vs. commissioning	p. 95
Schedule integration	p. 97
Engineering and procurement	p. 98
Engineering and construction	p. 99
Building vs. turnover	p. 101
The project and the product	p. 103
Change control	p. 103
Scope changes	p. 103
Baseline changes	p. 104
Managing change	p. 105
Objectives of change control	p. 106
Results	p. 107
Case example--Preliminary engineering	p. 109
Change control during construction	p. 109
Progress monitoring	p. 110
Status	p. 110
Analysis	p. 111
Value engineering	p. 114
Defining value	p. 114
Value engineering defined	p. 114
The VE process	p. 114
Pareto's law	p. 117
VE results	p. 117
Reporting	p. 121
Project status	p. 122
Summary	p. 123
Period progress	p. 124
Where to next?	p. 126
Current good manufacturing practice: Project impacts	p. 129
What does the FDA look for?	p. 130
Buildings and facilities	p. 130
Materials handling and storage	p. 131
Equipment	p. 131
Engineering design	p. 131
Cleanliness	p. 133
General construction cleanliness	p. 133
Piping, HVAC, and equipment	p. 134
Documentation	p. 135
Qualification and validation	p. 135
Master plan	p. 136
Design qualification	p. 137
Installation qualification	p. 138
Turnover package	p. 139
Operational qualification	p. 139
Performance qualification	p. 142
Execution	p. 142
Project budgets	p. 143
Schedules	p. 145
References	p. 145
Validation master plan	p. 146
Sample installation qualification (IQ) for WFI system	p. 148
Turnover Packages	p. 176
Mechanical systems	p. 181
Process piping	p. 182
Design issues	p. 182
Fabrication and installation	p. 184
System cost	p. 184
Constructability reviews	p. 184
Material procurement	p. 188
Cleanliness	p. 191
Documentation	p. 192
Testing, cleaning, and passivation	p. 195
Modular fabrication concepts	p. 195
Potential problems--What can go wrong	p. 197
Inspection	p. 198
Contracting--Finding the right company	p. 200
HVAC systems	p. 203
Facility requirements	p. 204
Design issues	p. 206
Filtration	p. 208
Temperature	p. 208
Pressurization	p. 210
Facility layout	p. 212
Cost savings--Where to look	p. 212
Construction and installation issues	p. 213
Operation costs--What you should know	p. 214
References	p. 216
GMP compliance in architectural design and construction	p. 217
Layout	p. 217
Segregation and flows	p. 218
Space considerations	p. 220
Service areas--Where do you put all this stuff?	p. 221
Accessibility	p. 231
Cleanliness and cleanability	p. 233
Material selection	p. 234
Flooring systems	p. 235
Walls	p. 235
Ceilings	p. 236
Construction issues	p. 236
Details	p. 236
Costs	p. 241
Optional methods	p. 242
Renovation	p. 245
Issues	p. 246
References	p. 249
Commissioning	p. 251
What is commissioning?	p. 251
Commissioning and project execution	p. 252
Qualification	p. 252
Commissioning to support validation	p. 253
Benefits of commissioning	p. 254
The commissioning team	p. 255
Roles and responsibilities	p. 257
Scheduling the effort	p. 258
When to start planning	p. 258
When to start execution	p. 264
Functional and performance testing	p. 265
Documentation	p. 265
What types of documents?	p. 267
Lists	p. 267
Plans and procedures	p. 267
Installation and inspection	p. 267
Submittal requirements	p. 268
Closeout	p. 268
Commissioning problem sources	p. 269
References	p. 270
Quality management to meet regulatory requirements	p. 271
Engineering quality and compliance	p. 271
Quality overkill	p. 271
GMP reviews	p. 272
Specification language	p. 272
Detail	p. 277
Inspection philosophy	p. 282
Construction quality	p. 284
Program implementation	p. 284
Program attributes	p. 285
GMP walk-downs	p. 285
Requirements meeting	p. 285
Benchmarking	p. 285
Mock-up	p. 285
Closure inspection	p. 286
Punchlist	p. 286
Quality in work execution	p. 286
Architectural	p. 286
Sanitary piping	p. 287
HVAC	p. 288
Electrical	p. 288
Purchase orders	p. 288
Lessons learned	p. 289
References	p. 290
Establishment licensing	p. 291
What is the BLA?	p. 294
Establishment information	p. 294
General information	p. 295
Buildings and facilities	p. 295
Animal areas	p. 296
Equipment	p. 296
Production and testing	p. 302
Records	p. 302
Personnel	p. 302
The pre-BLA meeting	p. 303
Inspection	p. 303
Containment basics	p. 307
Regulatory requirements	p. 308
Containment design	p. 310
Primary containment	p. 310
Equipment design	p. 310
Drainage and effluent treatment	p. 313
Secondary containment	p. 315
Layout and building design	p. 315
HVAC systems	p. 318
Operational procedures	p. 320
Project impact	p. 320
References	p. 320
Sample gowning/degowning procedure	p. 321
Multiproduct facilities for biologics	p. 325
Regulatory background	p. 326
Definitions	p. 326
Engineering design	p. 328
Facility design	p. 328
Process description	p. 328
Layout	p. 329
HVAC systems	p. 332
Sterilization systems	p. 335
Open vs. closed systems	p. 335
Scheduling	p. 336
Changeover	p. 336
Personnel	p. 339
Equipment	p. 339
Environmental monitoring	p. 340
Cleaning/changeover validation	p. 340
Defining clean	p. 341
Cleaning validation	p. 342
Manufacturing considerations	p. 342
Fermentation	p. 342
Purification	p. 343
Filling	p. 34
References	p. 346
Sample changeover cleaning procedure	p. 348
Contract formulation and philosophy	p. 351
What is a contract?	p. 351
Format	p. 352
Basic elements	p. 352
Execution formats	p. 353
Lump sum	p. 353
Other fixed-price contract forms	p. 354
Cost-plus contracts	p. 355
Time and expenses, time and material	p. 355
Design-build vs. construction management	p. 356
Scope of work	p. 356
Bid analysis and selection process	p. 357
References	p. 358
Future trends	p. 359
Manufacturing	p. 359
Manufacturing technologies	p. 360
Industry restructuring	p. 361
Regulatory changes	p. 361
References	p. 362
Index	p. 363
Table of Contents provided by Rittenhouse. All Rights Reserved.

Sterile Product Facility Design and Project Management

At a Glance

Hardcover

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How to return your order

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