Reprinted from

PHARMACEUTICAL ENGINEERING
The Official Magazine of ISPE API Facility Design
November/December 2008, Vol. 28 No. 6

This White
Paper presents A Risk-Based Approach to Defining
the Briefly
Exposed (Briefly Levels of Protection within API
Open) concept
in the context of Facility Design: The Concept of Briefly
Intermediate and
API processing
based on
Exposed (Briefly Open)
adopting a risk-
based approach
as outlined in
by Stan Newberger and Dr. Trish Melton
the API
Baseline Guide.

T
Introduction Figure 1 (with FDA agreement), was at-
his White Paper is written in support of tempting to give manufacturers an option of
the ISPE Baseline Guide on Active utilizing the Protected category (Level II), which
Pharmaceutical Ingredients (API), in allows for drug substance protection in certain
which a new concept, Briefly Exposed circumstances without having to use the more
(Briefly Open) was introduced. The discussion highly restrictive Controlled condition (Level
will expand on the concept, provide further III). Experience shows that many manufactur-
clarification, and demonstrate how to use the ers did not take advantage of this Protected
concept in practice. This White Paper will focus category in practice, because they felt that
on the Briefly Exposed (Briefly Open) concept there would be greater risk associated with it.
in the context of Intermediate and API process- This low use of Level II indicated a lack of
ing based on adopting a risk-based approach. understanding of the risks which were or were
not present.
Background The FDA suggests that manufacturers un-
The ISPE Baseline Guide: Active Pharmaceu- derstand the ultimate risk to the patient and
tical Ingredients, published in June 2007, is a focus on the areas of greatest patient risk.
revision and update to the ISPE Baseline During the design of API facilities, there needs
Guide: Bulk Pharmaceutical Chemicals, pub- to be an awareness of which areas represent the
lished in June 1996. In the original Guide, the greatest risk to the API and the greatest risk to
concept of a process step being a critical process the patient. This risk-based approach was inte-
step either due to chemistry or due to physical grated into the new Baseline Guide and a third
contamination was presented. The tools to con- condition was added to the former Table 2-1:
trol physical contamination also were given Briefly Exposed (Briefly Open). It is shown as
and presented as the Levels of Protection. It Figure 2.9: Recommended Levels of Protection
was recognized that the Levels of Protection, - Figure 2.
identified and defined in Chapter 2 of the This new concept allows manufacturers an-
original Guide as Level I General, Level II other degree of freedom in their operations.
Protected, and Level III Controlled, also are They will be able to briefly open their processes
related to the criticality of the step. With that for various reasons (sampling, adding ingredi-
as a basis, Table 2-1 Recommended Level of ents) for short time periods and under certain
Protection was developed - Figure 1. circumstances and to apply the most appropri-
Figure 1 recognizes two conditions: Not Ex- ate levels of protection (Level I, II, or III) based
posed (Closed) or Exposed (Open). There is not on risk mitigation. An assessment of the risk to
an intermediate condition of opening a process the API and ultimately to the patient is an
for a short amount of time (Briefly Open). appropriate method for manufacturers to es-
tablish what those circumstances are.

Copyright ISPE 2008 NOVEMBER/DECEMBER 2008 PHARMACEUTICAL ENGINEERING 1

 API Facility Design
Regardless of the final intended use of the API (i.e., foot
powder versus oral dosage versus injectable)?

The original Guide and the revised Guide both define three
different Levels of Protection: Level I General, Level II
Protected, Level III Controlled. The definitions of each of
these Levels of Protection are in Chapter 2 of the Guides.
Each of these levels will have a specific economic and opera-
tional impact on the manufacture of the API. Each also will
introduce a different risk of contamination to the API or
intermediate. Table 2-1 (1996 Guide) and Figure 2.9 (2007
Figure 1. Recommended Level of Protection (BPC Baseline Guide, Guide) give the manufacturer a way to determine the appro-
Table 2-1). priate Level of Protection depending on whether the opera-
External Contamination tion is occurring during a critical or non-critical unit opera-
Potential contamination may contact the API or intermedi- tion as well as the degree of exposure of the operation.
ate from sources that are either internal or external to the The main difference between the original version of the
processing equipment. It is expected that risks to the API and Levels of Protection Table and the newer version is the
intermediate from both of these sources will be managed and addition of a Briefly Exposed (Briefly Open) option. In addi-
appropriately mitigated. tion, the new Guide clarifies that criticality should be re-
External contamination comes from the external environ- viewed at the unit operation level. This approach highlighted
ment to which the API or intermediate is exposed. An opera- the usefulness and usability of the Level II category of
tion is exposed (open) if the API or intermediate is exposed to protection when a manufacturer is able to fully define the risk
the environment during the processing step, or not exposed scenario.
(closed) if the API or intermediate is not exposed to the
environment. Why Briefly Exposed?
Where external contamination can impact the impurity Exposed (Open) and Not Exposed (Closed) are definitive
profile of the API or intermediate, it is termed critical. terms. The process is either open or its not. However, is the
Therefore, this use of the word critical is analogous to the use risk of contamination the same when a vessel is open for eight
of the word when referring to critical parameter or critical hours, as it is when it is opened for one hour, as it is when it
unit operations. is opened for a few seconds? Obviously, the risk will be
different in each case. The risk to the API or intermediate also
Levels of Protection will be different in each case depending on which method of
The concept of Levels of Protection was introduced as a tool protection is utilized. Ultimately, the risk to the patient could
in the original Guide to aid in determining how extensive the also be different depending on all of the above as well as the
protection from the environment, and potential contami- intended patient use.
nants, an API or intermediate would need, i.e., does it need Recognizing that a very brief (brief time) opening of a
the same amount of protection: process to perform a specific activity could present an eco-
nomic and operational advantage over a completely closed
From the moment the process starts until the very end? process, and recognizing that a very brief (brief time) opening
Through every step (critical step versus non-critical step)? of a process within either a non-critical or a critical unit
operation could be protected to allow a low risk to the API or
intermediate, the Briefly Exposed (Briefly Open) option was
added.
The Guide states that Briefly Exposed (Briefly Open)
refers to an opening of a few seconds. The few seconds is the
time that it is envisioned to open a port on the process vessel
and to either add an ingredient or to take a sample quickly.
If the operation is not a part of a critical unit operation, Figure
2.9 (Figure 2) shows that this could be accomplished with a
Level I General level of protection. If the operation is a part
of a critical unit operation, Figure 2.9 (Figure 2) shows that
this could be accomplished with a Level II Protected level of
protection.
The Briefly Exposed (Briefly Open) option was added
because it is presumed to be a very low risk option that will
have a positive impact on the manufacture of APIs from an
Figure 2. Recommended Levels of Protection (API Baseline
Guide, Figure 2.9). economic and operational perspective. However, each manu-

2 PHARMACEUTICAL ENGINEERING NOVEMBER/DECEMBER 2008 Copyright ISPE 2008

 API Facility Design
facturer still needs to assess the risk for each of their specific
scenarios, always keeping in mind the risk to the patient.

Risk to the Patient versus

Risk to the Operator
In considering risk, it is important that the consequences of
concern are highlighted and the level of risk is objectively
assessed. In that way, the risk assessment can be shown to be
both repeatable and reliable, for example:

Repeatable if the same person conducted the risk assess-

ment at two different times, assuming the situation had
not changed, then the risk level would be the same.
Reliable if two different people conducted the risk as-
sessment at the same time, but separately, then the risk
level would be the same.
Figure 3. External Contamination Review Decision Flowchart (API
Baseline Guide, Figure 6.3).
In terms of the concept of Briefly Open (Briefly Exposed), it is
important that the level of risk is objectively assessed in More than one technique is proposed so that users can
terms of the risk to the patient. However, exposure of a select the most appropriate one based on the data they have
process to the surrounding environment also can cause risks available. The following example scenario will be used with
to personnel working in the area and environmental risks. each technique and associated tool:
The intent of this White Paper is to only cover the risk to
patient through impacting product quality. A crystallizer hand-hole needs to be open (exposed) for a
short period of time (Briefly Open) in order to insert seed
Risk-Based Approach during the unit operation (crystallization).
In Chapter 3 of the revised Guide, a risk assessment approach
was suggested. It was based on using risk decision flowcharts Tool 1 Decision Flowchart in API Baseline
which themselves were developed considering specific risk Guide
scenarios applicable to the manufacture of APIs and their This tool is introduced in the API Baseline Guide. In terms
intermediates. Figure 3.2 in the Guide proposes a 4-stage of supporting Stage 4 of the risk assessment process (Con-
process to assess and mitigate risk to patient. In summary: tamination Review), Figure 3.6 (Figure 3) describes the
decisions that need to be made in order to define the level of
Stage 1 Facility Designation the use of facility will impact protection for a specific unit operation. By using contamina-
the potential risks that can arise, e.g., dedicated versus tion review questions (CRQ), it allows the user to determine
multi-use facilities have different levels of potential cross if the operation is briefly open and then, based on level of risk
contamination risk. The type of product being manufac- (and a further set of contamination risk questions), deter-
tured also should be considered. mine the most appropriate level of protection based on miti-
Stage 2 Process Review the manufacturing process will gating risk to patient - Table A. This decision flowchart
follow a number of unit operations through the facility and technique supports three risk based decisions to identify the
each has the potential to introduce process risks, i.e., risks appropriate level of protection for a unit operation:
due to the process chemistry.
Stage 3 Contamination Review the facility and equip- Decision 1 Any probability of risk?
ment (internal and external processing environment) has Decision 2 Magnitude of probability of risk?
the potential to introduce physical contamination risks. Decision 2 Impact of risk?
Stage 4 Impact Assessment the systems within a facility
CRQ (b) Risk Probability CRQ (c) Risk Impact
can be direct, indirect, or of no impact in terms of product
Processing open during normal Q1. Multi-purpose facility (potential
quality and therefore, can also introduce risks to product operations? for cross contamination)?
quality which require mitigation. Large volume material charging each Q2. Ability for external contaminants
batch? to impact the product impurity profile?
Extended period of open for process Q3. Could external contamination in
External Contamination Review adjustments, charging, sampling? the downstream process go undetected
The focus of this White Paper is the assessment of the risk of External physical contamination can (and not be removed)?
external contamination and to specifically review how the enter the processing environment?
Yes to any of the above = HIGH risk probability Yes to Q3 = CRITICAL risk impact
concept of Briefly Exposed (Briefly Open) can be used while not No to all the above = LOW risk probability Yes to Q1 or Q2 = Likely CRITICAL risk impact
introducing any risk to patient. Therefore, this White Paper No to all the above = Non-Critical risk impact
focuses on three different techniques to assess the level of risk
Table A. Contamination Review Questions (API Baseline Guide,
from external contamination and to mitigate appropriately. summary of Tables 3.3 and 3.4).

Copyright ISPE 2008 NOVEMBER/DECEMBER 2008 PHARMACEUTICAL ENGINEERING 3

 API Facility Design
Phase One Phase Two
Failure Mode Failure Effect S Causes O Controls D Risk Action Plan S O D P
E C E E C E R
V C T
Score V C T P
N

<insert briefly open exposure risk <insert a <insert how this <insert how this <calc <insert action>
typically how contamination could description of the situation could situation is score>
enter the process> impact on the occur> detected>
process>
Scoring System
SEV: 1 to 5 based on impact on product quality; 1 is OCC: 1 to 5 based on likelihood of contamination DET: 1 to 5 based on ability for the contamination
low and 5 is high during failure mode (exposure); 1 is low and 5 is high to be detected; 1 is easily and 5 is not detected
Table B. Briefly Open (Exposed) FMEA Template.

If the example scenario is used with Figure 3 and Table A, on the failure effect. The scoring system for this type of
then the following is the result: analysis is shown in Table B. Severity is linked to the
impact of the contamination on the process and therefore
Decision 1 there is a risk of external contamination. process criticality as previously discussed.
Decision 2 the risk is of a low probability due to time- Causes for each identified failure mode, the cause should
scale of exposure. be explained. This needs to be a realistic scenario.
Decision 3 the risk has a high impact due to unit Occurrence (OCC) score a numerical score is assigned
operation criticality. based on how likely the cause would be to occur. The
scoring system for this type of analysis is shown in Table
Based on these decisions the appropriate level of protection B.
is Level II. In this case, the hand-hole is protected during Controls identify the current controls in place which
exposure through use of a portable enclosure which sur- would detect the failure mode.
rounds the hand-hole. The operator uses a standard SOP Detection (DET) score a numerical score is assigned
which outlines how he must minimize contamination, e.g., based on the controls and the ability for the failure mode
clean gloves, clean paper overalls with no pockets. to go undetected. The scoring system for this type of
analysis is shown in Table B.
Tool 2 FMEA1 Risk Priority Number (RPN) this is a calculation: RPN =
Failure Mode and Effect Analysis (FMEA) is a structured SEV OCC DET.
method for identifying and analyzing failure modes/defects
within a process, system, or product. It is usually completed At this stage, the failure modes can be ranked according to
on a component by component basis and produces a Risk RPN score. During facility design, the FMEA can be used as
Priority Number (RPN) that allows prioritization of any a design tool looking at the risks and associated risk priority
subsequent action planning. number in the proposed facility design.
The FMEA technique develops mitigating actions to elimi-
nate and/or reduce failure modes and/or their impact and/or Phase Two
increase detectability. It can be used to review potential After the Risk Priority Number (RPN) has been calculated,
scenarios which deliver external contamination into a pro- the second part of the analysis can begin.
cess and therefore identify the appropriate level of protection
for a unit operation. Action plan based on the RPN, define which failure
modes require action and then define the action plan.
Phase One Rescoring based on the action plan, review whether the
The initial part of the process involves failure mode or defect Severity (PS), Occurrence (PO), and Detection (PD) score
identification, description, and then scoring. In terms of the has or will alter and calculate an updated Risk Priority
application of the FMEA technique to the assessment of Number (PRPN).
external contamination risks via a briefly open operation, the
following terms can be defined: The reduction in risk priority number will be an indication of
the mitigation of the risk. In terms of the briefly exposed
Failure mode all the various ways that external contami- scenario, it should indicate whether Level II or III solutions
nation can enter a process during the briefly exposed are required to reduce the risk priorty number to an appropri-
scenario should be listed essentially these are all the ate level.
things that could go wrong. If the example scenario is used with Table B, the following
Failure effect for each identified failure mode, the conse- results are shown. Table C highlights a number of failure
quence needs to be described in terms of the potential modes for this situation: when the contamination is likely to
impact should contamination enter the process. impact the process and therefore the product and ultimately
Severity (SEV) score a numerical score is assigned based the patient.

4 PHARMACEUTICAL ENGINEERING NOVEMBER/DECEMBER 2008 Copyright ISPE 2008

 API Facility Design
Phase One Phase Two
Failure Mode Failure Effect S Causes O Controls D Risk Action Plan P P P P
E C E S O D R
V C T
Score P
N

Potential briefly exposed scenario: crystallizer unit operation, addition of 100g of seed to the vessel via the manually opened hand-hole
Debris above the exposed hand-hole Debris enters 5 Shedding materials 3 Operator likely to 1 15 Ensure temporary 5 1 1 5
the process used in general see if anything cover over the
facility and debris drops into the hand-hole is in
falls in during 5 hand-hole place
second opening
Operator contamination as he opens Contamination 5 Operator has 3 Likely 5 75 Operation SOP 5 1 1 5
the hand-hole and inserts the seed enters the process contamination on contamination states that
hands which will be small operator must
comes off during 5 and not easy wear gloves to
second operation to see conduct operation
5 Operator drops 4 Operator likely to 1 20 Operation SOP 5 1 1 5
something in the see if anything states that
hand-hole by drops into the operator must wear
mistake in rush to hand-hole a clean disposable
complete operation suit (one use)
Potential contamination from the Contamination 5 General 3 Cleaning SOP in 1 15 None check 5 3 1 15
equipment used to weigh the seed enters the dispensing place including dispensing SOP is
process room used cleaning labels being followed
Potential contamination from the Contamination 5 Disposable 1 SOP in place 1 5 None check 5 1 1 5
equipment used to weigh the seed enters the equipment meant to to ensure new charging SOP is
process be used once only receptacle used being followed
Risk summary: The action plans reduce the risk priority numbers to an acceptable level. All the action plans will protect the unit operation and are all Level II solutions.
Table C. Briefly Open (Exposed) FMEA Example.

All the actions proposed to mitigate the risks are to put tion where there is the potential for external contamination
protection in place during the dispensing and charging opera- by considering it to be a critical control area. The technique
tion, in other words give the situation Level II protection. is in two parts:

Tool 3 HACCP1 Part 1 Identification of all critical control areas within

The Hazard and Critical Control Point (HACCP) technique the process
can be used in a briefly exposed scenario. The technique is Part 2 Hazard analysis and control
generally used to identify, manage, and control specific,
detailed areas of the process. It relies on: During Part 1, the user should review the process flow
diagram and consider each unit operation in turn. All unit
the identification of critical control areas and within these operations which have the potential for chemical or physical
critical control points contamination should be considered Critical Control Areas
the identification of hazards likely to impact these (CCA). In this way, a CCA can be defined as any combination
the management of critical control limits through defini- of unit operation and contamination scenario which can
tion of a method to identify and control the hazard. adversely impact the product and therefore the patient. A
process exposure to external contamination is therefore a
The HACCP technique confirms actions which will manage a CCA.
potential hazard within control limits. It can be used to During Part 2, the user should analyze each CCA in turn
identify the appropriate level of protection for a unit opera- using the HACCP Tool - Table C.

HACCP Tool
Process/Facility: <insert process or facility> Unit Operation: <insert name>
Hazard CCA CCP (Y/N) Critical Control Limit (CCL) Hazard Identification Control Mechanism
Measure Target
<insert a description of the <describe the <confirm <insert the <insert the <insert the control <insert description of how
contamination hazard > critical whether this measure and target value> mechanism to be applied> the control action will be
control area(s) hazard is a units> applied >
affected by this critical control
hazard> point or not>
HACCP Summary
<insert summary comments on the status of the HACCP and impact on outcome in terms of risk to the patient>
Table D. HACCP Tool.1

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 API Facility Design
HACCP Tool
Process/Facility: Process ABC in Facility XYZ Unit Operation: Crystallization Seed Charging
Hazard CCA CCP (Y/N) Critical Control Limit (CCL) Hazard Identification Control Mechanism
Measure Target
Normal shedding facility materials Opening the yes Shedding materials Zero shedding The debris may be seen falling into Temporary clean cover made
of construction above the open hand-hole in vicinity of materials above or the crystallizer however unlikely and of non-shedding materials to
hand-hole falls into the crystallizer for 5 seconds hand-hole around the hand-hole so only noticed at the end of process be placed around the hand-hole
Operator sheds contamination yes Zero shedding Debris is unlikely to be seen falling One use disposable gloves of a
from hands as he opens the materials on into the crystallizer and so only non-shedding material will be worn
hand-hole and inserts the seed operator hands noticed at end of process by operators for this operation
Operator sheds contamination yes Zero shedding The debris may be seen falling into One use disposable overalls made
from clothing as he opens the materials on the crystallizer however unlikely and of a non-shedding material will be
hand-hole and inserts the seed operator clothing so only noticed at end of process worn by operators for this operation
Contamination enters the Dispensing yes Level of clean Zero cross Cross contamination will not The Level III area will be subject
seed from the dispensing seed in the in dispensing contamination in be seen and so only noticed to a cleaning SOP. The dispensing
room environment (Level III) Dispensing room dispensing room at end of process room particulate count is
Room controlled by normal processes
Contamination enters the yes Level of clean Zero cross Cross contamination will not One use disposable dispensing
seed from the equipment of dispensing contamination on be seen and so only noticed at equipment to be used
used to weigh the seed equipment dispensing equipment end of process
Potential contamination from the equipment used to dispense the seed
The control mechanisms in place as a part of the routine operation reduce the hazards to an acceptable level. All the control mechanisms will protect the unit operation and are all Level II solutions.
Table E. Briefly Open (Exposed) HACCP Example.

Hazard - it is usual to brainstorm the potential hazards If the example scenario is used with Table D, then the
which could occur within each CCA. In the case of review- following is the result. Table E highlights a number of
ing a process exposure to external contamination, the hazards for this situation: when the contamination is likely
hazards relate to the ways in which external contamina- to impact the process and therefore the product and ulti-
tion could enter the process. mately the patient.
CCA - it is usual to collate together common hazards All the control limits proposed to mitigate the risks are to
across a number of CCAs. For example, the dispensing of put protection in place during the dispensing and charging
raw materials may impact a number of different reactor operation, in other words, give the situation Level II protec-
modules. tion.
CCP (Y/N) - by asking two key questions, the Critical
Control Points (CCPs) can be defined for each potential Risk versus Cost Benefits
hazard. A yes (Y) or no (N) should be inserted although The risk-based approach under discussion is an objective way
for reviews, it would be usual to omit the non CCPs. to balance risk versus cost, i.e., risk to patient versus cost to
- Question 1 Does a control measure exist for this manufacturer and ultimately the patient. It is appropriate to
hazard within this unit operation? consider this balance. No process is 100 percent risk free to
- Question 2 Is control at this unit operation necessary be so would be cost prohibitive. However, risk to patient has
to prevent, eliminate, or reduce the risk of the hazard to be appropriately managed and mitigated.
to the product and therefore the patient? The tools in this White Paper are an attempt to stop
Critical Control Limit (CCL) - as previously defined, these manufacturers being too risk adverse and to using Level III
are limits within which a hazardous situation needs to be Controlled, as a solution to all product exposure scenarios.
controlled in order to safeguard product quality. For each The cost of reactor modules, for example, can be significantly
CCL, there should be a defined measure with units and a different and there should be a clear business rationale for
target range, minimum and/or maximum. this additional expenditure, i.e., to protect the patient.
Hazard identification the way that the normal operation Table F illustrates the relative differences in the cost of the
of the process will highlight the hazard, should it occur, different types of spaces.
should be identified. It is important that manufacturers realize the significance
Control mechanism the way that the normal operation of of the decision to use the different levels of protection and to
the process will be used to bring the CCL back into the use data and objective reasoning to be risk appropriate.
accepted range should be identified. This is the method by
which the design will incorporate adherence to the CCL Level of Protection Level I Level II Level III
when the hazard occurs. Relative Cost 1X 1.2X !.7X
HACCP summary - each time the HACCP is reviewed, the
Table F. The relative differences in the cost of the different types
analysis and summary of the probable outcome for the of spaces (cost data courtesy of CE&IC API database) .
process and product should be interpreted.

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 API Facility Design
Conclusions and Recommendations Board of Brooklyn Polytechnic University. As a member of
Different situations generate different data which require ISPE, Newberger has given several courses on the design of
different analyses. The use of three different risk assessment pilot plants both API and biotech industry. Newberger was
techniques has demonstrated that they all developed the the Technical Consultant for the United States Task Team
same outcome in terms of how the example risk scenario was for the development of the ISPE Baseline Guide: Active
mitigated. In terms of the Briefly Exposed (Briefly Open) Pharmaceutical Ingredients (published in June 2007). He
concept, the tools demonstrate that time is not the only factor also has written the Concepts and Regulatory Philosophy,
which determines risk level. Containment, and Pilot Plant Chapters in the ISPE
Manufacturers are encouraged to understand their pro- Baseline Guide on Active Pharmaceutical Ingredients. He
cess and to apply a method of risk assessment so that the can be contacted by telephone: +1-609-387-1700 or by email:
concept of Briefly Exposed (Briefly Open) can be used to [email protected].
pragmatically design API facilities. CE&IC, 2 Terri Ln., Suite 125, Burlington, New Jersey
08016-4902, USA.
Future Steps
The results of this White Paper will be used in interactive Dr. Trish Melton is Managing Director of
sessions at various ISPE Conferences to generate further MIME Solutions Ltd., an engineering and
feedback on the concept of Briefly Exposed (Briefly Open). management consultancy providing project
The overall goal is to give manufacturers a third option when management, business change management,
considering levels of protection for their processes; to ensure regulatory, and GMP consulting for pharma-
that Level II Protected is used appropriately to manage and ceutical, chemical, and healthcare clients.
mitigate risk to patient. Melton has worked as a project manager and
project management consultant on engineer-
References ing and non-engineering projects worldwide, predominantly
1. Melton, Trish "Real Project Planning: Developing a Project within the global pharmaceutical industry. She is a chartered
Delivery Strategy," Elsevier, Oxford, Great Britain (2008), Chemical Engineer and a Fellow of the Institution of Chemi-
ISBN: 978-0-7506-8472-9. cal Engineers (IChemE), where she was the founder Chair of
the IChemE Project Management Subject Group and re-
About the Authors cently authored an IChemE publication, the Project Manage-
Stan Newberger, PE, is the co-founder and ment Toolkit. As an ISPE Member, Melton served on the
Principal of CE&IC. During his 37-year ca- working group that updated ISPEs Bulk Pharmaceutical
reer, he has designed many pilot plants for Chemicals Baseline Guide, and is the Founder Chair of the
the pharmaceutical and biotech industry. Project Management Community of Practice. She has pre-
This has included the USs first fully vali- sented on various subjects at ISPE conferences, including
dated bulk pharmaceutical chemical pilot project management, quality risk management, and lean
plant for GlaxoSmithKline as well as pilot manufacturing. She also is the developer and main presenter on
plants for Pfizer, Schering-Plough, Novartis, the ISPE Facility Project Management Course for those already
Boehringer Ingelheim, Bristol-Myers Squibb, Burroughs working in pharmaceuticals and the associated Compliance
Wellcome, Hoffmann-La Roche, Wyeth, and others. Newberger Module intended for Project Managers entering the pharmaceu-
also has designed bioprocess pilot plants for GlaxoSmithKline, tical industry. She can be contacted by telephone: +44-1829-75-
Eli Lilly, Bristol-Myers Squibb, MedImmune, Laureate 9272 or by email: [email protected].
Pharma, and Emergent BioSolution. He holds a BS in chemi- MIME Solutions Limited, Gable Cottage, Childwall Farm,
cal engineering from Brooklyn Polytechnic, an MBA from Kelsall Road, Tarvin Chester, Cheshire, CH38NR, United
Rider College, and has taken further management courses at Kingdom.
the Wharton School. He currently serves on the Advisory

Copyright ISPE 2008 NOVEMBER/DECEMBER 2008 PHARMACEUTICAL ENGINEERING 7