d1-2 - ich q8,9,10 qsm

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Day - 1, Session - 2Day - 1, Session - 2

““Current Regulatory Perspective-Current Regulatory Perspective-Pharmaceutical Quality System Pharmaceutical Quality System

ManagementManagement””(1 h 40m)(1 h 40m)

Speaker -Speaker - Sumant Baukhandi, PhDSumant Baukhandi, PhD

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About Your SpeakerAbout 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 SpeakerAbout 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 CoverPoints 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 ChallengesNew 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 ChallengesNew 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 InitiativeNew 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 InitiativesFDA Initiatives

“Desired State”

PAT Initiative CGMP InitiativeC

ritical Path Initiative

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Partners in ICH ProcessPartners in ICH Process

Who are the partners in the ICH process?

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Pharmaceutical Development Pharmaceutical Development (ICH Q8)(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 inspectorsWhat is Pharmaceutical Development?

The aim of pharmaceutical development is to design a quality product and the manufacturing process to deliver the product in a reproducible manner Guidance for Industry Q8 Pharmaceutical Development.htm

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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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It discusses – 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) Why this? Biological activity Why? Permeability Why?

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It discusses – 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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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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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..confirm appropriateness of components (i.e., excipients)

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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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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 learning at development stages

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Risk Based Approach Risk Based Approach (ICH Q9)(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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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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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- Components

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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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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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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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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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What Q9 does not do?

Q9 does not eliminate Regulatory requirements

Does not shift decision making from company to regulatory authority

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Risk Based Approach Risk Based Approach (ICH Q9(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 SystemPharmaceutical Quality System (ICH Q10)(ICH Q10)

ICH Q10 is under development

It will 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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With the eventual introduction of Q10, the US-FDA’s 21st century New Initiatives will be fully launched

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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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Quality Management:

Utilization of science and risk-based systems to enable post-approval change and improvement

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Challenges in Implementing a Challenges in Implementing a Quality SystemQuality 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 Challenges in Implementing a Quality SystemQuality System

Background:

Quality By Design (Q8)+

Quality Risk Management (Q9)+

Modern Robust Quality System (Q10)

Lower Risk Operations,Technical Innovation,Continual Improvement, andOptimized Change Management Process

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Challenges in Implementing a Challenges in Implementing a

Quality SystemQuality 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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SummarySummary

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 Q10New challenges are experienced in their

implementation

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THANKS!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: [email protected] ; [email protected]

Website: www.pigmp.com

d1-2 - ich q8,9,10 qsm

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