Guidance for Industry

Q8, Q9, and Q10

Questions and Answers

U.S. Department of Health and Human Services

Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)

May 2010
ICH
Guidance for Industry
Q8, Q9, and Q10
Questions and Answers

Additional copies are available from:

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Phone: 301-796-3400; Fax: 301-847-8714
[email protected]
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and/or

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http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
 
 
 
 
 
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)

May 2010
ICH
 TABLE OF CONTENTS

I. INTRODUCTION (1)....................................................................................................... 1
II. QUESTIONS AND ANSWERS....................................................................................... 2
A. For General Clarification (1.1) ..................................................................................................... 2
B. Quality by Design (QbD) Topics (2) ............................................................................................. 3
1. Design Space (2.1) ........................................................................................................................... 3
2. Real-Time Release Testing (2.2) ...................................................................................................... 5
3. Control Strategy (2.3) ...................................................................................................................... 7
C. Pharmaceutical Quality System (3) .............................................................................................. 8
D. Impact of New ICH Quality Guidance on GMP Inspection Practices (4) .............................. 10
E. Knowledge Management (5) ....................................................................................................... 11
F. Software Solutions (6).................................................................................................................. 13
 Contains Nonbinding Recommendations

Guidance for Industry1

Q8, Q9, and Q10

Questions and Answers

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this guidance.

I. INTRODUCTION (1)

Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances
in the ICH regions have given rise to requests for clarification. This question and answer (Q&A)
document is intended to clarify key issues. The guidance reflects the current working procedure
of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and
Q10 guidances.

The benefits of harmonizing technical requirements across the ICH regions can be realized only
if the various quality ICH guidances are implemented and interpreted in a consistent way across
the three regions. The Q-IWG is tasked to develop Q&As to facilitate implementation of existing
quality guidance.

The Q&As reference the following ICH guidances available on the Internet at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
under International Conference on Harmonisation — Quality:

• Q8 (R2) Pharmaceutical Development (includes the Q8 parent guidance (Part I) and the
annex (Part II), which provides further clarification of the Q8 parent guidance and
describes the principles of quality by design)
• Q9 Quality Risk Management
• Q10 Pharmaceutical Quality Systems

1
This guidance was developed within the Quality Implementation Working Group of the International Conference
on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has
been subject to consultation by the regulatory parties, in accordance with the ICH process. The Q&As in this
document have been endorsed by the ICH Steering Committee at Step 4 of the ICH process, April 2009, June 2009,
and October 2009. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of
the European Union, Japan, and the United States.

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 Contains Nonbinding Recommendations

FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.

II. QUESTIONS AND ANSWERS

A. For General Clarification (1.1)

Q1: Is the minimal approach accepted by regulators?
A1: Yes. The minimal approach as defined in Q8(R2) (sometime also called “baseline”
or “traditional” approach) is the expectation that is to be achieved for a fully
acceptable submission. However, the “enhanced” approach as described in ICH
Q8(R2) is encouraged (Ref. Q8(R2) Annex, appendix 1). (Approved June 2009)

Q2: What is an appropriate approach for process validation using ICH Q8, Q9, and
Q10?
A2: The objectives of process validation are unchanged when using ICH Q8, Q9, and
Q10. The main objective of process validation remains that a process design yields
a product meeting its predefined quality criteria. ICH Q8, Q9, and Q10 provide a
structured way to define product critical quality attributes, design space, the
manufacturing process, and the control strategy. This information can be used to
identify the type and focus of studies to be performed prior to and on initial
commercial production batches. As an alternative to the traditional process
validation, continuous process verification (see definition in ICH Q8R(2)
glossary) can be utilized in process validation protocols for the initial commercial
production and for manufacturing process changes for the continual improvement
throughout the remainder of the product lifecycle. (Approved October 2009)

Q3: How can information from risk management and continuous process
verification provide for a robust continual improvement approach under ICH
Q8, Q9 and Q10?
A: Like the product itself, process validation also has a lifecycle (process design,
process qualification and ongoing process verification). A risk assessment
conducted prior to initial commercial validation batches can highlight the areas
where particular focus and data collection could demonstrate the desired high
level of assurance of commercial process robustness. Continual monitoring (e.g.,
via continuous process verification) can further demonstrate the actual level of
assurance of process consistency and provide the basis for continual improvement
of the product. Quality Risk Management methodologies of ICH Q9 can be

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applied throughout the product lifecycle to maintain a state of process control.

(Approved October 2009)

B. Quality by Design (QbD) Topics (2)

Q1: Is it always necessary to have a design space (DS) or real-time release (RTR)
testing to implement QbD?

A1: Under Quality by Design, establishing a design space or using real-time release
testing is not necessarily expected (ICH Q8(R2)). (Approved April 2009)

1. Design Space (2.1)

Q1: Is it necessary to study multivariate interactions of all parameters to develop a

design space?

A1: No, the applicant should justify the choice of material attributes and parameters
for multivariate experimentation based on risk assessment and desired operational
flexibility. (Approved April 2009)

Q2: Can a design space be applicable to scale-up?

A2: Yes, when appropriately justified (for additional details, see Q8(R2) Annex
section II.D.4 (2.4.4)). An example of a scale-independent design space is
provided in the European Federation of Pharmaceutical Industries and
Associations (EFPIA) Mock P2 document (EFPIA Mock P2 submission on
“Examplain”: Chris Potter, Rafael Beerbohm, Alastair Coupe, Fritz Erni, Gerd
Fischer, Staffan Folestad, Gordon Muirhead, Stephan Roenninger, Alistair
Swanson, A guide to EFPIA’s “Mock P.2” Document, Pharm. Tech. (Europe), 18,
December 2006, 39-44).

This example may not reflect the full regulatory requirements for a scale-up.
(Approved April 2009)

Q3: Can a design space be applicable to a site change?

A3: Yes, it is possible to justify a site change using a site independent design space
based on a demonstrated understanding of the robustness of the process and an in
depth consideration of site specific factors (e.g., equipment, personnel, utilities,
manufacturing environment, and equipment). There are region specific regulatory
requirements associated with site changes that need to be followed. (Approved
April 2009)

Q4: Can a design space be developed for single and/or multiple unit operations?

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A4: Yes, it is possible to develop a design space for single unit operations or across a
series of unit operations (see Q8(R2) Annex, section II.D.3 (2.4.3)). (Approved
April 2009)

Q5 Is it possible to develop a design space for existing products?

A5: Yes, it is possible. Manufacturing data and process knowledge can be used to
support a design space for existing products. Relevant information should be
utilized from e.g., commercial scale manufacturing, process improvement,
corrective and preventive action (CAPA), and development data.
For manufacturing operations run under narrow operational ranges in fixed
equipment, an expanded region of operation and an understanding of multi-
parameter interactions may not be achievable from existing manufacturing data
alone and additional studies may provide the information to develop a design
space. Sufficient knowledge should be demonstrated, and the design space should
be supported experimentally to investigate interactions and establish
parameter/attribute ranges. (Approved April 2009)

Q6: Is there a regulatory expectation to develop a design space for an existing

product?

A6: No, development of design space for existing products is not necessary unless the
applicant has a specific need and desires to use a design space as a means to
achieve a higher degree of product and process understanding. This may increase
manufacturing flexibility and/or robustness. (Approved April 2009)

Q7: Can a design space be applicable to formulation?

A7: Yes, it may be possible to develop formulation (not component but rather
composition) design space consisting of the ranges of excipient amount and its
physicochemical properties (e.g., particle size distribution, substitution degree of
polymer) based on an enhanced knowledge over a wider range of material
attributes. The applicant should justify the rationale for establishing the design
space with respect to quality attributes such as bioequivalence, stability,
manufacturing robustness etc. Formulation adjustment within the design space
depending on material attributes does not need a submission in a regulatory
postapproval change. (Approved June 2009)

Q8: Does a set of proven acceptable ranges alone constitute a design space?
No, a combination of proven acceptable ranges (PARs) developed from univariate
experimentation does not constitute a design space (see Q8(R2) Annex, section
II.D.5 (2.4.5)). Proven acceptable ranges from only univariate experimentation

4
 Contains Nonbinding Recommendations

may lack an understanding of interactions between the process parameters and/or

material attributes. However proven acceptable ranges continue to be acceptable
from the regulatory perspective but are not considered a design space (see ICH
Q8(R2) Annex, section II.D.5 (2.4.5)).

The applicant may elect to use proven acceptable ranges or design space for
different aspects of the manufacturing process. (Approved June 2009)

2. Real-Time Release Testing (2.2)

Q1: How is batch release affected by employing real-time release testing?

A1: Batch release is the final decision to release the product to the market regardless
of whether RTR testing or end-product testing is employed. End-product testing
involves performance of specific analytical procedures on a defined sample size
of the final product after completion of all processing for a given batch of that
product. Results of real-time release testing are handled in the same manner as
end-product testing results in the batch release decision. Batch release involves an
independent review of batch conformance to predefined criteria through review of
testing results and manufacturing records together with appropriate good
manufacturing practice (GMP) compliance and quality system, regardless of
which approach is used. (Approved April 2009)

Q2: Does real-time release testing mean elimination of end-product testing?

A2: Real-time release testing does not necessarily eliminate all end-product testing.
For example, an applicant can propose RTR testing for some attributes only or not
all. If all critical quality attributes (CQAs) (relevant for real-time release testing)
are assured by in-process monitoring of parameters and/or testing of materials,
then end-product testing might not be needed for batch release. Some product
testing will be expected for certain regulatory processes such as stability studies
or regional requirements. (Approved April 2009)

Q3: Is a product specification still necessary in the case of RTR testing?

A3: Yes, product specifications (see ICH Q6A and Q6B) still need to be established
and met, when tested. 2 (Approved April 2009)

Q4: When using RTR testing, is there a need for stability test methods?
A4: Even where RTR testing is applied, a stability monitoring protocol that uses
stability indicating methods is required 3 for all products regardless of the means
of release testing (see ICH Q1A and ICH Q5C). (Approved April 2009)

2
See 21 CFR 314.50(d)(1) and 21 CFR 211.165.

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 Contains Nonbinding Recommendations

Q5: What is the relationship between control strategy and RTR testing?
A5: RTR testing, if utilized, is an element of the control strategy in which tests and/or
monitoring can be performed as in-process testing (in-line, on-line, at-line) rather
than tested on the end product. (Approved April 2009)

Q6: Do traditional sampling approaches apply to RTR testing?

A6: No, traditional sampling plans for in-process and end-product testing involve a
discrete sample size that represents the minimal sampling expectations. Generally,
the use of RTR testing will include more extensive on-line/in-line measurement.
A scientifically sound sampling approach should be developed, justified, and
implemented. (Approved April 2009)

Q7: If RTR testing results fail or trending toward failure, can end-product testing be
used to release the batch?
A7: No, in principle the RTR testing results should be routinely used for the batch
release decisions and not be substituted by end-product testing. Any failure should
be investigated and trending should be followed up appropriately. However, batch
release decisions should be made based on the results of the investigations. In the
case of failure of the testing equipment, please refer to the previous question. The
batch release decision should comply with the content of the marketing
authorization and GMP compliance. (Approved April 2009)

Q8: What is the relationship between in-process testing and RTR testing?

A8: In-process testing includes any testing that occurs during the manufacturing
process of drug substance and/or finished product. Real-time release testing
includes those in-process tests that have a direct impact on the decision for batch
release through evaluation of critical quality attributes. (Approved June 2009)

Q9: What is the difference between “real time release” and “real-time release
testing”?
A9: The definition of real-time release testing in Q8(R2) is “the ability to evaluate
and ensure the acceptable quality of in-process and/or final product based on
process data, which typically includes a valid combination of measured material
attributes and process controls.”

3
21 CFR 314.50(d)(1).

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 Contains Nonbinding Recommendations

The term real time release in the Q8(R2), step 2 document was revised to “real-
time release testing” in the final Q8(R2) Annex to fit the definition more
accurately and thus avoid confusion with batch release. (Approved June 2009)

Q10: Can surrogate measurement be used for RTR testing?

A10: Yes, RTR testing can be based on measurement of a surrogate (e.g., process
parameter, material attribute) that has been demonstrated to correlate with an in-
process or end-product specification (see ICH Q8(R2); Annex, section II.E (2.5)).
(Approved June 2009)

Q11: What is the relationship between RTR testing and parametric release?
A11: Parametric release is one type of RTR testing. Parametric release is based on
process data (e.g., temperature, pressure, time for terminal sterilization,
physicochemical indicator) rather than the testing of material and/or a sample for
a specific attribute. (Approved October 2009)

3. Control Strategy (2.3)

Refer to the definition of control strategy provided in the ICH Q10 glossary:

A planned set of controls, derived from current product and process

understanding that assures process performance and product quality. The controls
can include parameters and attributes related to drug substance and drug product
materials and components, facility and equipment operating conditions, in-
process controls, finished product specifications, and the associated methods and
frequency of monitoring and control.

Q1: What is the difference in a control strategy for products developed using the
minimal approach vs. “quality-by-design” approach?

A1: Control strategies are expected irrespective of the development approach. Control
strategy includes different types of control proposed by the applicant to assure
product quality (ICH Q10, section IV.B.1 (3.2.1)), such as in-process testing and
end-product testing. For products developed following the minimal approach, the
control strategy is usually derived empirically and typically relies more on
discrete sampling and end-product testing. Under QbD, the control strategy is
derived using a systematic science and risk-based approach. Testing, monitoring,
or controlling is often shifted earlier into the process and conducted in-line, on-
line, or at-line testing. (Approved April 2009)

Q2: Are GMP requirements different for batch release under QbD?

A2: No, the same GMP requirements apply for batch release under minimal and QbD
approaches. (Approved April 2009)

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Q3: What is the relationship between a design space and a control strategy?

A3: A control strategy is required for all products.4 If a design space is developed and
approved, the control strategy (see ICH Q8(R2), Annex, section IV (4)) provides
the mechanism to ensure that the manufacturing process is maintained within the
boundaries described by the design space. (Approved April 2009)

Q4: What approaches can be taken in the event of on-line/in-line/at-line testing or

monitoring equipment breakdown?
A4: The control strategy provided in the application should include a proposal for use
of alternative testing or monitoring approaches in cases of equipment failure. The
alternative approach could involve use of end-product testing or other options,
while maintaining an acceptable level of quality. Testing or monitoring equipment
breakdown should be managed in the context of a deviation under the quality
system and can be covered by GMP inspection. (Approved June 2009)

Q5: Are product specifications different for minimal versus QbD approaches?
A5: In principle no, product specifications are the same for minimal and QbD
approaches. For a QbD approach, the control strategy can facilitate achieving the
end product specifications via real time release testing approaches (see ICH
Q8(R2) Annex, appendix 1). Product must meet specification, when tested. 5
(Approved October 2009)

C. Pharmaceutical Quality System (3)

Q1: What are the benefits of implementing a pharmaceutical quality system (PQS)
(in accordance with ICH Q10)?

A1: The benefits are:

• Facilitated robustness of the manufacturing process, through facilitation of
continual improvement through science and risk-based postapproval change
processes
• Consistency in the global pharmaceutical environment across regions
• Enable transparency of systems, processes, and organizational and
management responsibility
• Clearer understanding of the application of a quality system throughout
product lifecycle

4
21 CFR 314.50(d)(1).
5
21 CFR 211.165.

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 Contains Nonbinding Recommendations

• Further reducing risk of product failure and incidence of complaints and

recalls, thereby providing greater assurance of pharmaceutical product
consistency and availability (supply) to the patient
• Better process performance
• Opportunity to increase understanding between industry and regulators and
more optimal use of industry and regulatory resources; enhance
manufacturer’s and regulators’ confidence in product quality
• Increased compliance with GMPs, which builds confidence in the regulators
and may result in shorter inspections
(Approved April 2009)

Q2: How does a company demonstrate implementation of PQS in accordance with

ICH Q10?

A2: When implemented, a company will demonstrate the use of an effective PQS
through its documentation (e.g., policies, standards), its processes, its
training/qualification, its management, its continual improvement efforts, and its
performance against pre-defined key performance indicators (see ICH Q10
glossary on performance indicator).

A mechanism should be established to demonstrate at a site how the PQS operates

across the product lifecycle, in an easily understandable way for management,
staff, and regulatory inspectors, e.g., a quality manual, documentation, flowcharts,
procedures. Companies can implement a program in which the PQS is routinely
audited in-house (i.e., internal audit program) to ensure that the system is
functioning at a high level. (Approved April 2009)

Q3: Is it necessary to describe the PQS in a regulatory submission?

A3: No, however relevant elements of the PQS (such as quality monitoring system,
change control, and deviation management) can be referenced as part of the
control strategy as supporting information. (Approved April 2009)

Q4: Will there be certification that the PQS is in accordance with ICH Q10?

A4: No. There will not be a specific ICH Q10 certification program. (Approved April
2009)

Q5: How should the implementation of the design space be evaluated during
inspection of the manufacturing site?

A5: Inspection should verify/assess that manufacturing operations are appropriately

carried out within the design space. The inspector in collaboration with the
assessor, where appropriate, should also verify successful manufacturing
operations under the design space and that movement within the design space is

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managed within the company’s change management system (see ICH Q10,
section IV. B.3 (3.2), Table III). (Approved April 2009)

Q6: What should be done if manufacturing operations run inadvertently outside of

the design space?

A6: This should be handled as a deviation under GMP. For example, unplanned “one-
off” excursions occurring as a result of unexpected events, such as operator error
or equipment failure, would be investigated, documented, and dealt with as a
deviation in the usual way. The results of the investigation could contribute to the
process knowledge, preventive actions, and continual improvement of the
product. (Approved April 2009)
Q7: What information and documentation of the development studies should be
available at a manufacturing site?
A7: Pharmaceutical development information (e.g., supporting information on design
space, chemometric model, risk management) is available at the development site.
Pharmaceutical development information that is useful to ensure the
understanding of the basis for the manufacturing process and control strategy,
including the rationale for selection of critical process parameters and critical
quality attributes, should be available at the manufacturing site.
Scientific collaboration and knowledge sharing between pharmaceutical
development and manufacturing is essential to ensure the successful transfer to
production. (Approved June 2009)

Q8: Can process parameters be adjusted throughout the product lifecycle?

A8: Process parameters are studied and selected during pharmaceutical development
and monitored during commercial manufacturing. Knowledge gained could be
utilized for adjustment of the parameters as part of continual improvement of the
process throughout the lifecycle of the drug product (see ICH Q10, section IV
(3)). (Approved June 2009)

D. Impact of New ICH Quality Guidance on GMP Inspection Practices (4)

Q1: How will product-related inspections differ in an ICH Q8, Q9 and Q10
environment?

A1: In the case of product-related inspection (in particular, preauthorization)

depending on the complexity of the product and/or process, greater collaboration
between inspectors and assessors could be helpful (for example, for the
assessment of development data). The inspection would normally occur at the
proposed commercial manufacturing site, and there is likely to be greater focus on
enhanced process understanding and understanding relationships, e.g., critical
quality attributes (CQAs), critical process parameters (CPPs). The inspection
might also focus on the application and implementation of quality risk

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management principles, as supported by the pharmaceutical quality system (PQS).

(Approved April 2009)

Q2: How will system-related inspections differ in an ICH Q8, Q9, and Q10
environment?

A2: The inspection process will remain similar. However, upon the implementation of
ICH Q8, Q9, and Q10, inspections will have greater focus on (but not only focus
on) how the PQS facilitates the use of e.g., quality risk management methods,
implementation of design space, and change management (see ICH Q10).
(Approved April 2009)

Q3: How is control strategy approved in the application and evaluated during
inspection?

A3: Elements of control strategy submitted in the application will be reviewed and
approved by the regulatory agency. However, additional elements are subject to
inspection (as described in Q10). (Approved October 2009)

E. Knowledge Management (5)

Q1: How has the implementation of ICH Q8, Q9, and Q10 changed the significance
and use of knowledge management?

A1: Q10 defines knowledge management as: “Systematic approach to acquiring,

analyzing, storing, and disseminating information related to products,
manufacturing processes and components.”

Knowledge management is not a system; it enables the implementation of the

concepts described in ICH Q8, Q9 and Q10.

Knowledge management is not a new concept. It is always important regardless of

the development approach. Q10 highlights knowledge management because it is
expected that more complex information generated by appropriate approaches
(e.g., QbD, process analytical technology (PAT), real-time data generation, and
control monitoring systems) should be better captured, managed, and shared
during product life-cycle.

In conjunction with quality risk management, knowledge management can

facilitate the use of concepts such as prior knowledge (including from other
similar products), development of design space, control strategy, technology
transfer, and continual improvement across the product life cycle. (Approved
April 2009)

Q2: Does Q10 suggest an ideal way to manage knowledge?

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A2: No. Q10 provides a framework and does not prescribe how to implement
knowledge management. Each company decides how to manage knowledge,
including the depth and extent of information assessment based on its specific
needs. (Approved April 2009)

Q3: What are potential sources of information for knowledge management?

A3: Some examples of knowledge sources are:

• Prior knowledge based on experience obtained from similar processes
(internal knowledge, industry scientific and technical publications) and
published information (external knowledge: literature and peer-reviewed
publications)
• Pharmaceutical development studies
• Mechanism of action
• Structure/function relationships
• Technology transfer activities
• Process validation studies
• Manufacturing experience, e.g.,
— Internal and vendor audits
— Raw material testing data
• Innovation
• Continual improvement
• Change management activities
• Stability reports
• Product quality reviews/annual product reviews
• Complaint reports
• Adverse event reports (patient safety)
• Deviation reports, recall Information
• Technical investigations and/or CAPA reports
• Suppliers and contractors
• Product history and /or manufacturing history
• Ongoing manufacturing processes information (e.g., trends)

Information from the above can be sourced and shared across a site or company,
between companies and suppliers/contractors, products, and across different
disciplines (e.g., development, manufacturing, engineering, quality units).
(Approved April 2009)

Q4: Is a specific dedicated, computerized information management system required

for the implementation of knowledge management with respect to ICH Q8, Q9,
and Q10?

A4: No, but such computerized information management systems can be invaluable in
capturing, managing, assessing, and sharing complex data and information.
(Approved April 2009)

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Q5: Will regulatory agencies expect to see a formal knowledge management

approach during inspections?
A5: No. There is no added regulatory requirement for a formal knowledge
management system. However, it is expected that knowledge from different
processes and systems will be appropriately utilized.
Note: “formal” means: it is a structured approach using a recognized methodology
or information technology (IT) tool, executing and documenting something in a
transparent and detailed manner. (Approved June 2009)

F. Software Solutions (6)

Q1: With the rapid growth of the new science and risk-based quality paradigm
coupled with the IWG efforts to facilitate globally consistent implementation of
Q8, Q9, and Q10, a number of commercial vendors are now offering products
that are being marketed as “ICH compliant solutions” or ICH Q8, 9, and 10
Implementation software, etc. Is it necessary for a pharmaceutical firm to
purchase these products to achieve a successful implementation of these ICH
guidances within their companies?

A1: No. The ICH Implementation Working Group has not endorsed any commercial
products and does not intend to do so. ICH is not a regulatory agency with
reviewing authority and thus does not have a role in determining or defining “ICH
compliance” for any commercial products. While there will likely be a
continuous proliferation of new products targeting the implementation of these
ICH guidances, firms should carry out their own evaluation of these products
relative to their business needs. (Approved April 2009)

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