Day - 1, Session - 2

“Current Regulatory Perspective-

Pharmaceutical Quality System
Management”
(1 h 40m)

Speaker - Sumant Baukhandi, PhD

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 About Your Speaker
 Sumant Baukhandi, PhD
- Microbiologist by education
- B.Sc (Hon) Microbiology, M.Sc. Microbiology, PhD
Microbiology
 Experience: 29 years – Pharmaceutical industry
 QA & Regulatory professional by training & experience
 Extensive experience in the following areas:
- Microbiological practices
- Facility Designing (GMP & Regulatory requirements)
- QA systems (Aseptic processing, non-sterile operations)
- Validations
- Regulatory submissions & inspections
- GMP & Regulatory Audits for compliance

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 About Your Speaker
 Companies served: Aristo Pharmaceuticals, Ranbaxy Laboratories
Ltd, Orchid Healthcare
 Last position: President – Regulatory & QA in Orchid HC
 Currently: Founder Director – Pharma Institute of GMPs, based in
Dehradun
 Pharmaceutical consultancy & Organizing training
programs for pharmaceutical industry
 Achievements: Evolved Quality systems, Regulatory Practices,
Microbiological Practices, Validation systems now being used in
Indian pharma industry
 Obtained several Regulatory approvals for Ranbaxy & Orchid on some of the
High Risk Category products
Please visit my website: www.pigmp.com

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 Points to Cover
 Pharmaceutical Development – (ICH Q8)
(Quality By Design)
What challenges it brings to us?
 Risk Based Approach – (ICH Q9)
(Quality Risk Management)
Are we gearing up?
 Quality System Management – (ICH Q10)
(Effective Quality System)
View the World differently!

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 New Challenges
 How did we get here?
> FDA’s 21st Century New GMP Initiatives
> ICH Activity
 What is this New GMP Initiative??

 What is ICH?

 What is the Industry’s reaction to above??

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 New Challenges
 Links between ICH Q8, Q9 & Q10

 ICH Q8 – status : Adopted by all regions

 ICH Q9 – status : Adopted by all regions

 ICH Q10 – status : Step 2 (under development)

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 New GMP Initiative
 Seeks to:
 Integrate - Quality Systems + the Risk Management
Approaches - into the existing programs and
 Encourage - Adoption of modern and innovative
manufacturing technology!!
 Intended to:
 Enhance - the integration of pre-approval review & GMP
programs
 Use - existing & emerging science and analysis to ensure
limited resources are best targeted to address important
quality issues, especially those
 Associated with predictable or identifiable risks
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 FDA Initiatives

PAT Initiative CG
MP
Init
iat
ive

Criti
cal P
“Desired State” ath I
nitia
tive

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 Partners in ICH Process
 Who are the partners in the ICH process?

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 Pharmaceutical Development
(ICH Q8)
 What is the scope of ICH Q8?
 It covers the Pharmaceutical
Development section of an
application, intended to provide a
more comprehensive understanding
of the product and manufacturing
process for reviewers and
inspectors
What is Pharmaceutical Development?
 The aim of pharmaceutical
development is to design a quality
product and the manufacturing
process to deliver the product in a 13
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 Pharmaceutical Development
(ICH Q8)
 ICH Q8 – suggested contents for 3.2.P.2 Pharmaceutical
Development section of a regulatory submission in the
ICH M4 CTD format
 This section provides an opportunity to present the
knowledge gained through the application of scientific
approaches, and risk management, to the development of a
product and its manufacturing process
 Those critical aspects of drug substances,
excipients, and manufacturing processes
that present a significant risk* to product
quality, and therefore should be
monitored or otherwise controlled, should
be identified and discussed.
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 Pharmaceutical Development
(ICH Q8)
 Itdiscusses – critical aspects of drug
substances such as -
physicochemical & biological
properties that might need to be
examined & monitored
 Which are the critical aspects of drug
substances?
 Solubility Why?
 Water content Why?
 Physical characteristics! Why
PSD?
 Polymorphism (crystal properties)
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 Pharmaceutical Development
(ICH Q8)
 Itdiscusses – critical aspects of
excipients
 Which are the critical aspects of
excipients??
 The excipients chosen, their
concentration, and the characteristics
that can influence -
.the drug product performance (e.g.,
stability, bio-availability), or
.manufacturability
should be discussed relative to the
respective function of each excipient.
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 Pharmaceutical Development
(ICH Q8)
 The ability of excipients
- to provide their intended functionality,
and
- to perform throughout the intended
drug product shelf life,
should also be demonstrated
 Few examples - antioxidants,
penetration enhancers,
disintegrants, release controlling
agents

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 Pharmaceutical Development
(ICH Q8)
 It discusses – critical aspects of
manufacturing processes that
present a significant risk*
- to product quality, and therefore,
- should be monitored or
- otherwise controlled
 It is critical to consider the
formulation attributes together with
the available manufacturing process
options,
..so as to address selection of the
mfg process and
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 Pharmaceutical Development
(ICH Q8)
 An assessment of “process
robustness” can be useful in
risk assessment and risk
reduction,
 to support future
manufacturing and process
optimisation,
 especially, in conjunction with
the use of structured risk
management tools
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 Pharmaceutical Development
(ICH Q8)
 What are the Challenges?
 Identification of Critical Control
Points
 Implementing adequate monitoring
– PAT needs to be introduced
 Is industry sensitive?
- API manufacturer?
- Drug product manufacturer?
 Education at all levels on how to
describe the Quality Overall
Summary
 Documenting adequately the
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learning at development stages
 Risk Based Approach
(ICH Q9)
 What is the scope of this guidance?

 Quality Risk Management (QRM) is the main focus of this

guidance

 QRM is a valuable component of an effective Quality

System.

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 Risk Based Approach
(ICH Q9)
 What is Risk?

 Risk is defined as the combination of probability

of occurrence of harm and the severity of that
harm
 The protection of the patient by managing the risk
to quality should be considered of prime
importance

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 Risk Based Approach
(ICH Q9)
What is its Scope?
 Drug substances (active substance),
 Drug (medicinal) products,
 Biological and biotechnological
products
 Including the selection and use of
- Raw materials
- Solvents
- Excipients
- Packaging and labeling materials
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 Risk Based Approach
(ICH Q9)
 What are the two primary principles of
quality risk management?

 Evaluation of the risk to quality should ultimately link

back to the protection of the patient
 Level of effort, formality and documentation of the QRM
should be commensurate with the level of risk and be
based on scientific knowledge

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 Risk Based Approach
(ICH Q9)
 What is Risk Assessment?

 It includes – Risk Identification, Risk Analysis and Risk

Evaluation

 What might go wrong?

 What is the likelihood (probability) it will go wrong?
 What are the consequences (severity)?

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 Risk Based Approach
(ICH Q9)
 What is Risk Control?

 It includes decision making to reduce and / or accept risk

 Purpose is to reduce risk to an acceptable level
 Risk control might focus on following questions:
- Is the risk above an acceptable level?
- What can be done to reduce, control or eliminate risk?
- What is the appropriate balance among benefits, risks
and resources?
- Are new risks introduced as a result of controlling the
identified risks?
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 Risk Based Approach
(ICH Q9)
 What makes Q9 different compared to other
Quality Guidelines?
 It provides principles and a framework for decision
making
 Q9 is a quality improvement methodology
 It is a “guidance” not an “SOP”
- Simple
- Flexible
- Not mandatory
 It supports science-based decision making
 Facilitates communication and transparency
 Supports build up trust
 Q9 is for both industry and competent authorities
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 Risk Based Approach
(ICH Q9)
What Q9 does not do?

 Q9does not eliminate Regulatory

requirements

 Does
not shift decision making from
company to regulatory authority

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 Risk Based Approach
(ICH Q9)
 What are the Challenges on Q9?
 Analyzing the risk
 Evaluation
 Determining what is an acceptable risk!
 Mitigation of risk to acceptable level
 Communication

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 Pharmaceutical Quality System
(ICH Q10)
ICH Q10 is under development

 Itwill describe an approach to developing an

“effective quality system”
 Aimed at facilitating continuous improvement
through Q8 & Q9
 Paradigm shift from CGMP compliance to
comprehensive systems quality approach
throughout lifecycle.

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 Pharmaceutical Quality System
(ICH Q10)
With the eventual introduction of Q10,
the US-FDA’s 21st century New
Initiatives will be fully launched

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 Pharmaceutical Quality System
(ICH Q10)
 Special Benefits of Implementing an Effective
Quality System
 Global industry regional regulations
 Stronger Role for Quality in Organization
 Win:Win:Win Patient:Industry:Regulator
- Better Tech transfer
- Better Process Control & Monitoring
- Better Change Control
- Improved Process Capability
- Fewer non-conformities & better investigations
- Proactive approach
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 Pharmaceutical Quality System
(ICH Q10)

Quality Management:

 Utilization of science and risk-based systems to

enable post-approval change and improvement

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 Challenges in Implementing a
Quality System
SCOPE:
 Drug Substances (large & small molecules)
 Drug products
 Throughout the product life-cycle:
- Process development
- Technology Transfer
- Routine Manufacturing

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 Challenges in Implementing a
Quality System
Background:

Quality By Design (Q8)

+
Quality Risk Management (Q9)
+
Modern Robust Quality System (Q10)

Lower Risk Operations,

Technical Innovation,
Continual Improvement, and
Optimized Change Management Process
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 Challenges in Implementing a
Quality System
What are the Challenges posed by the upcoming
Q10?
 Combining the Q8 & Q9 principles!
 End result is possible if the development is science based
 Applying the knowledge of development and risk in the
regulatory dossiers preparation
 Describing your Effective Quality System
 Regulators need to trust firms on their proposed Quality
System

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 Summary
 21st Century New GMP Initiatives has been a boon
to the industry and regulators alike
 What better way to fulfill the Initiatives than to have
the cross-linking of the ICH guidelines
ICH Q8 ICH Q9

ICH Q10
 New challenges are experienced in their
implementation

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 THANKS!
For inquiries please contact –
Sumant Baukhandi, PhD

Director – Pharma Institute of GMPs,

Director – pharmaACCESS

7, Phase-1, Vasant Vihar,

Dehradun-246 006
Uttaranchal State, INDIA

Landphone: 91-135 276 3092

Cellphone: 91- 99970 10901
Email ID: pigmpinstt@gmail.com ;
sumant091154@rediffmail.com

Website: www.pigmp.com

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