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06/08/09 1
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?
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New Challenges
Links between ICH Q8, Q9 & Q10
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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?
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Risk Based Approach
(ICH Q9)
What is Risk?
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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?
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Risk Based Approach
(ICH Q9)
What is Risk Assessment?
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Risk Based Approach
(ICH Q9)
What is Risk Control?
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
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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:
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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:
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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
Website: www.pigmp.com
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