Sterile Product Facility Design and Project Management, Second Edition

by Odum; Jeffrey N.

• ISBN13: 9780849318740
• ISBN10: 0849318742
• Edition: 2nd
• Format: Loose-leaf
• Copyright: 2004-03-29
• Publisher: CRC Press

Summary

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.

Table of Contents

Introduction to facility project management	1	(9)
Project management	1	(2)
Project philosophy	3	(5)
Planning	3	(2)
People	5	(1)
Control	6	(1)
Contracting	6	(2)
References	8	(1)
Project formation	9	(28)
Conceptual development	9	(7)
Functional objectives	10	(1)
Schedule objectives	11	(1)
Budget objectives	12	(4)
Organizing	16	(6)
Team selection	17	(2)
Project charter	19	(1)
Roles and responsibilities	20	(1)
Alignment	20	(2)
Project alternatives	22	(9)
Analyzing technology	23	(1)
Project management	24	(1)
Site evaluation	24	(3)
Conceptual scope and estimate	27	(1)
Scope definition	28	(1)
Conceptual estimate	28	(2)
Evaluation	30	(1)
Project definition	31	(6)
Risk analysis	31	(3)
Execution approach	34	(1)
Project control guidelines	34	(3)
Defining the project team	37	(16)
The owner's team	37	(1)
Approach	38	(1)
Selecting the architectural and engineering firm	38	(10)
When	38	(1)
How	39	(1)
Preparing the request for proposal	40	(3)
Proposal review	43	(3)
Selection criteria	46	(1)
Technical qualifications	46	(1)
Management qualifications	47	(1)
The Subtleties	48	(1)
Selecting the construction contractor	48	(5)
Engineer / procure / construct (EPC)	49	(1)
General contractor	49	(1)
Construction management	50	(1)
Selection process	50	(3)
Facility programming	53	(20)
First step	53	(1)
The process	54	(15)
Gathering data	54	(1)
Steps	55	(4)
Space requirements	59	(4)
Quality of construction	63	(1)
Budget	64	(1)
Time	64	(1)
Path forward	65	(1)
Types of information	65	(1)
Function	65	(1)
Form	65	(1)
Economy	66	(2)
Time	68	(1)
Communication	69	(1)
Results	69	(2)
References	71	(2)
Project control	73	(56)
Basic elements	73	(1)
Plan the work, work the plan	74	(1)
Work breakdown structure	75	(1)
Estimating	76	(11)
Preliminary estimates	77	(1)
Detailed estimates	78	(1)
Estimate development	79	(1)
Factored estimates	80	(2)
Analysis of factored estimates --- Rules of thumb	82	(2)
Estimate trending	84	(1)
Contingency development and management	85	(2)
Schedule	87	(16)
Schedule development and evaluation	87	(1)
Summary schedules	87	(2)
Activity breakdown	89	(1)
Long lead-time activities	89	(2)
Sequencing	91	(1)
Activity durations	92	(2)
Cash flow	94	(1)
Project completion	95	(1)
Mechanical completion vs. commissioning	95	(2)
Schedule integration	97	(1)
Engineering and procurement	98	(1)
Engineering and construction	99	(2)
Building vs. turnover	101	(2)
The project and the product	103	(1)
Change control	103	(7)
Scope changes	103	(1)
Baseline changes	104	(1)
Managing change	105	(1)
Objectives of change control	106	(1)
Results	107	(2)
Case example --- Preliminary engineering	109	(1)
Change control during construction	109	(1)
Progress monitoring	110	(4)
Status	110	(1)
Analysis	111	(3)
Value engineering	114	(7)
Defining value	114	(1)
Value engineering defined	114	(1)
The VE process	114	(3)
Pareto's law	117	(1)
VE results	117	(4)
Reporting	121	(2)
Project status	122	(1)
Summary	123	(6)
Period progress	124	(2)
Where to next?	126	(3)
Current good manufacturing practice: Project impacts	129	(52)
What does the FDA look for?	130	(1)
Buildings and facilities	130	(1)
Materials handling and storage	131	(1)
Equipment	131	(1)
Engineering design	131	(2)
Cleanliness	133	(2)
General construction cleanliness	133	(1)
Piping, HVAC, and equipment	134	(1)
Documentation	135	(7)
Qualification and validation	135	(1)
Master plan	136	(1)
Design qualification	137	(1)
Installation qualification	138	(1)
Turnover package	139	(1)
Operational qualification	139	(3)
Performance qualification	142	(1)
Execution	142	(3)
Project budgets	143	(2)
Schedules	145	(1)
References	145	(1)
Appendix 6.1 Validation master plan	146	(2)
Appendix 6.2 Sample installation qualification (IQ) for WFI system	148	(28)
Appendix 6.3 Turnover Packages	176	(5)
Mechanical systems	181	(36)
Process piping	182	(21)
Design issues	182	(2)
Fabrication and installation	184	(1)
System cost	184	(1)
Constructability reviews	184	(4)
Material procurement	188	(3)
Cleanliness	191	(1)
Documentation	192	(3)
Testing, cleaning, and passivation	195	(1)
Modular fabrication concepts	195	(2)
Potential problems --- What can go wrong	197	(1)
Inspection	198	(2)
Contracting --- Finding the right company	200	(3)
HVAC systems	203	(13)
Facility requirements	204	(2)
Design issues	206	(2)
Filtration	208	(1)
Temperature	208	(2)
Pressurization	210	(2)
Facility layout	212	(1)
Cost savings --- Where to look	212	(1)
Construction and installation issues	213	(1)
Operation costs --- What you should know	214	(2)
References	216	(1)
GMP compliance in architectural design and construction	217	(34)
Layout	217	(16)
Segregation and flows	218	(2)
Space considerations	220	(1)
Service areas --- Where do you put all this stuff?	221	(10)
Accessibility	231	(2)
Cleanliness and cleanability	233	(3)
Material selection	234	(1)
Flooring systems	235	(1)
Walls	235	(1)
Ceilings	236	(1)
Construction issues	236	(13)
Details	236	(5)
Costs	241	(1)
Optional methods	242	(3)
Renovation	245	(1)
Issues	246	(3)
References	249	(2)
Commissioning	251	(20)
What is commissioning?	251	(1)
Commissioning and project execution	252	(1)
Qualification	252	(1)
Commissioning to support validation	253	(1)
Benefits of commissioning	254	(1)
The commissioning team	255	(3)
Roles and responsibilities	257	(1)
Scheduling the effort	258	(7)
When to start planning	258	(6)
When to start execution	264	(1)
Functional and performance testing	265	(1)
Documentation	265	(3)
What types of documents?	267	(1)
Lists	267	(1)
Plans and procedures	267	(1)
Installation and inspection	267	(1)
Submittal requirements	268	(1)
Closeout	268	(1)
Commissioning problem sources	269	(1)
References	270	(1)
Quality management to meet regulatory requirements	271	(20)
Engineering quality and compliance	271	(13)
Quality overkill	271	(1)
GMP reviews	272	(1)
Specification language	272	(5)
Detail	277	(5)
Inspection philosophy	282	(2)
Construction quality	284	(5)
Program implementation	284	(1)
Program attributes	285	(1)
GMP walk-downs	285	(1)
Requirements meeting	285	(1)
Benchmarking	285	(1)
Mock-up	285	(1)
Closure inspection	286	(1)
Punchlist	286	(1)
Quality in work execution	286	(1)
Architectural	286	(1)
Sanitary piping	287	(1)
HVAC	288	(1)
Electrical	288	(1)
Purchase orders	288	(1)
Lessons learned	289	(1)
References	290	(1)
Establishment licensing	291	(16)
What is the BLA?	294	(1)
Establishment information	294	(13)
General information	295	(1)
Buildings and facilities	295	(1)
Animal areas	296	(1)
Equipment	296	(6)
Production and testing	302	(1)
Records	302	(1)
Personnel	302	(1)
The pre-BLA meeting	303	(1)
Inspection	303	(4)
Containment basics	307	(18)
Regulatory requirements	308	(2)
Containment design	310	(10)
Primary containment	310	(1)
Equipment design	310	(3)
Drainage and effluent treatment	313	(2)
Secondary containment	315	(1)
Layout and building design	315	(3)
HVAC systems	318	(2)
Operational procedures	320	(1)
Project impact	320	(1)
References	320	(1)
Appendix 12.1 Sample gowning/degowning procedure	321	(4)
Multiproduct facilities for biologics	325	(26)
Regulatory background	326	(1)
Definitions	326	(2)
Engineering design	328	(12)
Facility design	328	(1)
Process description	328	(1)
Layout	329	(3)
HVAC systems	332	(3)
Sterilization systems	335	(1)
Open vs. closed systems	335	(1)
Scheduling	336	(1)
Changeover	336	(3)
Personnel	339	(1)
Equipment	339	(1)
Environmental monitoring	340	(1)
Cleaning/ changeover validation	340	(2)
Defining clean	341	(1)
Cleaning validation	342	(1)
Manufacturing considerations	342	(4)
Fermentation	342	(1)
Purification	343	(3)
Filling	346	(1)
References	346	(2)
Appendix 13.1 Sample changeover cleaning procedure	348	(3)
Contract formulation and philosophy	351	(8)
What is a contract?	351	(2)
Format	352	(1)
Basic elements	352	(1)
Execution formats	353	(3)
Lump sum	353	(1)
Other fixed-price contract forms	354	(1)
Cost-plus contracts	355	(1)
Time and expenses, time and material	355	(1)
Design-build vs. construction management	356	(1)
Scope of work	356	(2)
Bid analysis and selection process	357	(1)
References	358	(1)
Future trends	359	(4)
Manufacturing	359	(1)
Manufacturing technologies	360	(1)
Industry restructuring	361	(1)
Regulatory changes	361	(1)
References	362	(1)
Index	363