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Formal 1CH Procedure - 5 Step procedure

>Initiated with the endorsement by the ICH Assembly of a Concept Paper and Business Plan.

>EWG (Expert Working Group): Develop a draft Guideline and implement in ICH regions of a
Harmonised Guideline.

Step 5 Implementation

Step4 Adoption of an lCH Harmonised Guideline

O
Stage I:Regional Regulatory consulatation: Regulatory
authorities and industry associations comment
Step3 Regulatory consultation and Discussion Stage i DIscussion of regionalconsuitation comments:
Stage ll: Finalisation of Step 3 Experts Draft Guideline

ICH Assembly agrees, based on the report of the EWG,

a ICH Parties consensus on Technical Document/b. that there is sufficient scientific consensus
Step 2 Regulatory Members will take the necessary actions to
Draft Guideline adoption by Regulators
develop the draft Guideline.

>EWG works to prepare a consensus draft of the

Technical Document, based on the objectives set out in
Step Consensus buiding- Technical Document the Concept Paper

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ICH Guidelines-QSEM

Quality Guidelines Safety Guidelines

Harmonisaton achievements in the Quality CH has prodtuced a cormprehensive set of
areia include muestones such as the
pivotal safrety Guioeines to urncover polenbal rks
conduct of stability studies, defining relevant Ke carcinogenicity. genotoxicaty an
thresholds for impurities tenting and a more reprotoxicity. A recent breakthrough has
fexible approach to pharmaceutical quality Deen a non-cinical testing stratogiy tor
based on Good Manufacturing Practice assessing the QT intervail prolongaton
(GMP) risk management. liability: the single most important cause of
drug withdrawals in recent years.

Efficacy Guidelines Muitidisciplinary Guidelines

The work carried out by ICH under the Those are the cross-cuting topics which do
Emcacy heading is concermed with the not mE uniquey into one o the auaaty
design,
conduct, satety and reporng o Safety and Eticacy categones. it includes
dlinical trials. It also covers nove types of the ICH medical teminology (MedDRAJ, he
medicines derived from biotechinological Common Technicat Document (CTD) and
procesoes and the use of the development of Electronic Standards for
pharmacogenetics/genomics techniques to the Transfer of Regulatory information
produce better targeted medicines. (ESTRI)

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ICH Guidelines-QSEM

C Quality Guidelines
Harmonisation achievements in the Quality
area include pivotal milestones such as the
conduct of stability studies, defining relevant
thresholds for impurities testing and a more
flexible approach to pharmaceutical quality
based on Good Manufacturing Practice
Safety Guidel ines
ICH has produced a comprehensive set of
safety Guidelines to uncover potential risks
ike carcinogenicity, genotoxicity and
reprotoxicity. A recent breakthrough has
been a non-clinical testing strategy for
assessing the QT interval prolongation
(GMP) risk management. liability: the single most important cause of
drug withdrawals in recent years.
O

E Efficacy Guidelines
The work carried out by ICH under the
Efficacy heading is concerned with the
design, conduct, safety and reporting of
clinical trials. It also covers novel types of
medicines derived from biotechnological
M Multidisciplinary
processes and the use of
pharmacogenetics/genomics techniques to
produce better targeted medicines.
Guidelines
Those are the cross-cutting topics which do
not fit uniquely into one of the Quality
Safety and Efficacy categories. It includes
the ICH medical terminology (MedDRA), the
Common Technical Document (CTD) and
the development of Electronic Standards for
the Transfer of Regulatory Information
(ESTRI)

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Q1A-Q1F: Stability
QIA(R2): Stability Testing of New Drug Substances and ProductsQ1A
QIB: Stability Testing : Photostability Testing of New Drug Substances
and Products
QIC: Stability Testing for New Dosage Forms
QID: Bracketing and Matrixing Designs for Stability Testing of New
Drug Substances and Products
QIE: Evaluation of Stability Data
Q1F: Stability Data Package for Registration Applications in Climatic
Zones IIl and IV. O
Q2: Analytical Validation
Validation of Analytical Procedures: Methodology
Q3A-Q3D: Impurities
Q3A(R2): Împurities in New Drug Substances
Q3B(R2): Impurities in New Drug Products
Q3CCR5): Impurities: Guideline for Residual SolventsQ3C,Q3C(M)
Q3D: Guideline for Elemental Impurities
Q3D: Implementation of Guideline for Elemental Impurities.
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Q4A-Q4B: Pharmacopeia
Q4APharmacopoeial Harmonisation
Q4BEvaluation and Recommendation of Pharmacopoeial Texts for Use in the
ICH Regions.
Q5A-Q5E: Quality of Biotechnological Products
Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived
from Cell Lines of Human or Animal OriginQ5A
Q5B: Analysis of the Expression Construct in Cells Used for Production
of r-DNA Derived Protein Products
Q5C: Stability Testing of Biotechnological/Biological Products O
Q5D: Derivation and Characterization of Cell Substrates Used for
Production of Biotechnological/Biological Products
Q5E: Comparability of Biotechnological/Biological Products Subject to
Changes in their Manufacturing Process.
a Q6A-Q6B: Specifications
Q6ASpecifications: Test Procedures and Acceptance Criteria for
New Drug Substances and New Drug Products: Chemical Substances
Q6BSpecifications: Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products.
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Q7: Good Manufacturing Practices

In February 1998, the ICH Steering Committee agreed that GMP
for Active Pharmaceutical Ingredients (APls) should be adopted as an
ICH Topic.
Q8: Pharmaceutical Development
This annex describes the principles of quality by design (QbD).
The annex is not intended to establish new standards, however, it shows
how concepts and tools (e.g., design space) outlined in the parent Q8
document could be put into practice by the applicant for all dosage forms. O
09:Quality Risk Management
This Guideline provides principles and examples of tools of
quality risk management that can be applied to all aspects off
pharmaceutical quality including development, manufacturing, distribution,
and the inspection and submission/review processes throughout the
lifecycle of drug substances and drug (medicinal) products, biological and
biotechnological products, including the use of raw materials, solvents,
excipients, packaging and labelling materials.
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Q10: Pharmaceutical Quality System

This Guideline applies to pharmaceutical drug substances and drug
products, including biotechnology and biological products, throughout the
product lifecycle.
Q11: Development and Manufacture of Drug Substances
This new guidance is proposed for Active Pharmaceutical Ingredients
(APIs) harmonising the scientific and technical principles relating to the
description and justification of the development and manufacturing process
(CTD sections S 2.2. S 2.6) of Drug Substances including both chemical O
entities and biotechnological/biological entities.
Q12: Lifecycle Management
This new guideline is proposed to provide guidance on a
framework to facilitate the management of post-approval Chemistry,
Manufacturing and Controls (CMC) changes in a more predictable and
efficient manner across the product lifecycle. Adoption of this new ICH
Guideline will promote innovation and continual improvement, and strengthen
quality assurance and reliable supply of product, including proactive planning
of supply chain adjustments.
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Stability
Provide evidence of how the quality of an Active Pharmaceutical
Ingredient (API) or Finished Pharmaceutical Product (FPP) varies with
time under the influence of a variety of environmental factors such as -

Temperature,
-
Humidity and
-Light. O
The stability programme also includes the study of product-related factors
that influence its quality, for example,
-
Interaction of API with excipients,
Container closure systems and
Packaging materials.

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Q1A (R2): Stability Testing of New Drug Substances and Products

-Minimum of three representative batches

Long Term Intermediate Accelerated

General torage 25 oC/60% RH 30 oC/65% RH 40 CI75% RH
(12 months) (6 months) (6 months)
Refrigerated 5 C NA 25 C/60% RH
Storage (12 months) (6 months)
O
Frozen Storage 20C NA NA
Below-20 °C Case-by-case
Semi-Permeable 25 C/40% RH 30 °C/65% RH 40 C/ NMT 25%
Or (6 months) RH
30 C/35% RH (6 months)
(12 months)
Stre sting Intentional degradation by various chemical and non-physical stressing conditions
Photostability: Impact of light on stability of product. 10
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ICH Q18: Photostability Testing of New Drug Substances and

Products
Describes requirements on photostability testing and defines light exposure t
be applied
To be tested on API if not photosensitive, no further testing required
O
-If photosensitive, to be continued on exposed finished product and product in

primary package, product in marketing package, where relevant

-Where necessary, impact of light during manufacturing process to be

evaluated

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ICH Q1C: Stability Testing of New Dosage Forms

Additional guidance to lICH Q1 A(R2) on new dosage forms ("line extensions")
for new substances

-Reduced requirements as regards time to be covered at LT storage

conditions at time of dossier submissions O
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ICH Q1D: Bracketing and Matrixing Designs for Stability

Testing of New Drug Substances and Products
Describes possibilities to apply reduced test designs, i.e. bracketing and matrixing
-Defines situations where reduced testing can be applied without additional
justification, with justification or where it is not applicable
Bracketing: Testing of extremes only
Matrixing: Testing of a different samples of factor combinations at different time
points during the study
O
Example of Bracketing design
Strength 50 mg Tb mg 100 mg
Batch 1 2312312 3
Container
size
15 ml
100 ml
TTT T T

500 ml
TTTI
Key:
T=Sample tested
T T T 13
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Example of Matrixing design

"One-Third Reduction"
24 36
Time point (months)
Batch
1s
SI
Batch 2
T
Batch 3 T TTT|TT
s2 Batch 1 T
TT T
Batch2T
Batch 3
Key: T= Sample
T
O
tested

"One-Half Reduction"
Time point (months) 6 9 12 18 24 36
S1 Batch 1
Batch 2
Bateh 3
S2 Batch 1

Batch 2
Batch 3 T 14
Key: Sample Jested
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ICH Q2 Analytical Validation

A guideline defining the validation parameters and describing characteristics to be
considered for the validation of analytical procedures

Defines criteria for the validation of the four most common types of analytical procedures:
Identification tests
-Quantitative tests for impurities O
-Limit tests for the control of impurities
Quantitative tests for the active moiety in APl or finished product or or other selected
components in the product

Defines typical analytical validation characteristics-

Accuracy, Precision, Repeatability, Intermediate Precision, Specificity, Detection Limit,
Quantitation Limit, Range
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ICHQ3 Impurities
A set of three guidelines addressing the chemistry and safety aspects of impurities,

including the listing of impurities in specifications.

Defines the thresholds for reporting, identification and qualification of impurities in APl and
finished product.

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ICH Q3 A (R) New Drug Substances

Classifies impurities: Organic, Inorganic and Residual Solvents
Defines rationale for the reporting and control of impurities as well as requirements
for listing impurities in specifications
Organic Impurities
Each specified identified impurity
Each specified unidentified impurity
Any unspecified impurity with acceptance criterion of NMT theidentification
threshold

Residual Solvents

Inorganic impurities

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Definitions
Identified impurity: ..impurity for which a structural characterization has been achieved

Qualification: ..is the process of acquiring and evaluating data that establishes the
biological safety of an individual impurity or a given impurity profile at the level(s) specified.
Specified impurity.. impurity that is individualy listed and limited with a specific acceptance
criterion in the specification. Can be either identified or unidentified. O
Unidentified impurity:. impurity for which a structural characterisation has not been
achieved and that is solely defined by qualitative analytical properties, e.g. chromatographic
retention time (RRT)
Unspecified impurity:..impurity that is limited by a general acceptance criterion, but not
individually listed with its own specific acceptance criterion in the specification

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Threshold for Impurities in API

Maximum daily|Reporting dentification Threshold Qualification Threshold

dose Threshold3

2g/day 0.05%
.I or 1.0mg/day
whichever is lower)
intakep.15% or 1.Omg/day
whichever is lower) O
>2g/day 0.03% p.05% 0.05%

Note: The amount of drug substance administered per day

Higher reporting thresholds should be scientifically justified
Lower thresholds can be appropriate if the impurity is unusually toxic

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ICH Q3C: Impurities: Guideline for Residual Solvents

Recommends acceptable amounts for residual solvents in
armaoautiala.

ClassI Known human carcinogens, strongly

Suspected human carcinogens, and
solvents to be avoided environmental fiazards

Non-genotoxic animal carcinogens or possible

causative agents of other irreversible toxicity.
O
Class II Solvents suspected of other significant but
reversible toxicities
solvents to be limited

Solvents with low toxic potential to man;

no health-based exposure limit is needed

ClassE IIsolvents with low toxic potential

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Classification of Residual Solvents

Class Benzene, carbon totrachloride,
1,2-dichloro@thane, 1,1-dichloroethone, 1,1,1-
solvents to be avoided trichloroethano

Acetonitrile, chloroform, cyclohexane,

dioxane, methanol,
.
methylbutylketone, O
Class II tetrahydrofurane, toluene,

solvents to be limited

Acetone, butanol, butyl acetate, DMSO, ethanol,

ethyl acetate, ethyl ether, heptane, isopropanol,

Classsolvents
Ill methylethyl ketone,
with low toxic potential

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ICH Q 6Zootifications Leave

Addressing the selection of tests and methods and setting

specifications for quality control of APl and finished products.
Intended to assist in the establishment of a single set of global
specifications for API and finished product.
O
Provides guidance on the setting and justification of acceptance
criteria and the selection of test procedures.

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Specifications:.. A list of tests, references to analytical procedures and appropriate

acceptance criteria, which are numerical limits, ranges or other criteria for the tests described.
Establishes the set of criteria to be met in order to be considered "acceptable for intended
use"
. Are proposed/justified by applicant and approved by regulatory authorities as conditions of
approval
O
.. Are one part of a total control strategy for the APl/product.

. Are chosen to confirm the quality.. rather than to establish full characterisation, should
focus on those characteristics useful in ensuring the safety and efficacy of the product.

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Universal Tests/Criteria API

Description

Identification
=HPLC/MS,
specific forthe substance (e.g.:
GC/MS)
IR, HPLC/UV (DAD),
O
Assay
specific stability indicating procedure
often possible to use method that is also used for
quantification of impurities (e.g. HPLC

Impurities (organic, inorganic, residual solvents)

specific /stability-indicating procedure
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Universal Tests/Criteria Product

Description
Identification
specific (IR, HPLC/UV (DAD),
HPLC/MS, GC/MS)
Assay O
specific/ stability-indicating procedure
(z.B. HPLC, which is also used for impurities quantification,
where applicable, results of content uniformity test can be used)

Impurities (organic, inorganic, residual solvents)

specific/stability-indicating procedure: degradation products and
impurities arising during the manufacturing processs
5

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CERTIFICATE OF ANALYSIS YM 9IOTEC

PHARMALAB PVT. LIMITED
EammhKnan.a.bdoas. Pharmatat
PRODUCcT BECLOMETHASONE DIPROPIONATE IP (UN-MICRONISED) (CAS No.: 5534-09-8)
BATCH No. BCDy18001 MFG DATE Navember 2018
AR FP181026 RETEST DATE October 2023
DATE OF SAMPLING 23/11/2018

Test Kesut Specification

sorip
wneyntalline powder, odourless. ceany-white, crystalline powder,
Solubilt Fucy
soiuil li acetorc a.d ia
chloroform; sparingly soluble in Freely solubie in acetone and in cistoroforms
ethanol (95%% practicaliy insoluble inpractically insotuble in watetthanol (95**
Identinootlon
wwrce peactically n
insolubla wal.
Concordant
Jaus
O
B. Chloride Cuuplies The 1lquld gives renction A of chlorides.
CRadet is time Complie n the Asaay, thc principal pcak in the
By HPLC)
obtained with the reference solution,
pecific opticnl rotarion Betwecn +88.0 and +940. calculated on
w/v solution in dioxan at +91.93
e drica basis
2
ght absorption 0.590 Between 0.57 and 0.60
Sulphated ash 0.04 % NMT01 ww
Los on drying
CAL105 for 3 hours) a.11% NMT 0.5 6 wrw
30 4 Between 96.0 and 103.0, %ww
y FIPLC) calculated on thhe dried busis
S Test
Particle
Malvern 5624 um 50.0 %100 um 26

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What and How

ICH Q8,Q9, 010 guidelines
O

are working together throughout the

product life cycle?

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ICH Q8, Q9 and Q10

Nov 2005 & Nov 2008
High level guidances (not prescriptive)
PHAEMAELTIA DVRLAHM
Science and risk-based
November 2005

Encourages systematic approaches

O
Applicable over entire product lifecycle
June 2008
Intended to work together to enhance
pharmaceutical product quality

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ICH Q8 (R2): Pharmaceutical Development

Describes science and risk-based approaches for pharmaceutical
product and manufacturing process development
Introduced concepts of design space and flexible regulatory
approaches O
Introduced concepts of Quality by Design (QbD) and provided
examples of QbD development approaches and design space

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Q8(R2)- Example QbD Approach

Product Pro file
Quality Target Product Profile (QTPP)

CQANS Determine "potential" critical quality attributes (CQAs)

Link raw material attributes and process parameters to

Risk Assessments
CQAS
O
Design Space
and perform risk assessment
Develop a design space (optionaland.not required)
Control Strategy
Design and implement a control strategy
Continual

Im provem ent Manage product lifecycle, including continual improvement

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ICH Q9:Quality Risk Management

Describes systematic processes forthe assessment, control,
communication and review of quality risks
Applies over product lifecycle: development, manufacturing and
distribution
Includes principles, methodologies and examples of tools for quality O
risk management
Assessment of risk to quality should:
Be based on scientific knowledge
Link to the protection of the patient
Extend over the lifecycle of the product
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Quality Risk Management Process - Q9

Initiate
Quality Risk Management Process

Risk Assessment
Risk Identification Proce ss
Develop m ent
Risk Analysis

Risk Evaluation
ptable
O
Risk Control
Risk Reduction
Control Strategy
Risk Acceptance Development

Output Result of the

Ouality Risk Management Process

Risk Review Continual

Review Events Im provem ent
of the product 32

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ICH Q10: Pharmaceutical Quality System

Describes key systems that facilitate establishment and maintenance of
a state of control for process performance and product quality
Facilitates continual improvement
Applies to drug substance and drug product throughout product lifecycle
Sound pharmaceutical development (Q8R(2)) in combination witha
robust PQS (Q010) provide opportunities for flexible regulatory
approaches. Relevant PQS elements include systems for:
Track and trend product quality
Maintain and update models as needed
Internally verify that process changes are successful

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Pharmaceutical Quality System -Q10

Pharmaceutical Quality System

Pharmaceutical Technology Commercial Product

Development Transfer Manufacturing Discontinuation

Investigational products
GMP
Manage ment Responsibilities

Process Performance & Product Ouality Monitoring System

POS Corrective Action I Preventive Action (CAPA) System
elements change Management System
Management Review

Knowledge Management
Enablers Quality Risk Management

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ICH Q8,Q9 and Q10 Working Together

Formu lation A ctivities:

QTPP Definition
Pre-Formulation Studie s
Formulation S creening
O ptim ization & Selectioon

Process Development Activities:

Process Screening
Lab S cale Development
Scale-Up S tuudies

Manufactu ringActivities:
S cale
O mercia
Manuta cturing
Batch Release
Continual Verific a tion &
Im provemen

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Formulation Development Activities

1CH Q BR2) Pharm aceutica CH9-QRM CHQT0PQS
Related Aetivities Activities
Activit ated
Knowledge Manaaement
Hubatance DioBvaabtity: KPD,. an
ae Am n1 to evaliate patieat Prior noW edge uen

sk understand ing. riek

e amenmt ane soope of
Pre-Fe rmulatien cheracteritation ot drug ubstance Deterhinn talüre modes and tik DOE)
Studles hysical propertieA) factar for arug eubstanc
Chemaatabuy ofdrug tuounoe physical en d chemicaf wTabity
Dveluumentrapor
EtC
Developmentat analybcalte
Eve

elopment
Screening DOEs
Formulation Exeipient and drug substance material O Ppatunitiea tor formal riak
Optimization
Selectian
and Property
DOF tor
k characterization
excig ient amounts
ss Ssmant

Stubility of drug ptoductanG otatag

Develop ivIvC relationships

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Process Development Activities

2Pharmaceutical HCHQ9-ORM CHQ10 POS
earated
Related Actvities Actvities Activities
Process Exploration of unt ope rations Determine failure modes, risk factors Batch records and
Screening Churacterlzabon otptoce runil sk operasonalguidelines
ntermediate tor ianulacluting
Tech Traner repo
Proces8 DOEs for processparameters and are oning ritk assestment to
Jdentfication and
Development tetactons wih mae rial atuibutes dete mine potentulgaraimeters
and DevelapTentorbeea TIDectng product quaity te.g
ptimization Operaonalrenges sh awa)
needs
Lab Stale) penentparameteis Delemine eriteal protes spp
proce
ifues aof sta e
Proces Pilot to verty lab scale knowledge e lapmentotcontolsagy
DOF and modeina efe cts of
Development scale
onrol risko nel for scale up
and Developmentofdesgn space
Optimization Developmentoron
ot scale)

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Technology Transfer

1CHQ8R2)-Pharmaceutical ICHQ9-QRM ICH O10-PQS

Development Related Related Integrated
Related Activides AcUVities ACHVities

Gan productand process knowledge Forms the basis for tie manufa cturmg Advance understundag tirough scaie

proves eectveness ofcontol aminary indication of

cheve productrea strategy focess performance and successtul
Contributes to pracessesvalida ion and niegration into manufacturing9
ongong contnualimprovement Gain knowle dge fromt franster and
acale up activites to enhanse the
basis for he controlstra te gy

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Commercial Manufacturing Activities

ICH Q8R2)-Pharmaceutical 1CH 09-QRM ICHQ 10-PQS
Deyerope erae Reloted nteptreteo

ReOedACUvIties Activities

Drug Product eerial scale rune to ve manutactunng. inchuding in desion nnaee

Documentouon upp
9weny wmo cotfot
eetation of on e Check procedures in the POS and analvtiral
methe
neasurement technalogi egprding risk from Pocess reprooueOY

S torage o oeverop o

Control TOf movement within

Coninuaroce y ehting Manage

OEP Erocmlre on plro
cation and ptoces tata, tmutw aniate
Improvement Evaluation ot process change outside of asinn anare neidina how and when to do isk
ng ocnped tect on
ntemeietes and prduts and eveluation at the chentge
APA

khowledae managemens 9E

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Commercial Manufacturing Activities

ICH Q8(R2) Pharmaceutical
-
ICH Q9 QRM ICH Q10- PQs
Development Related Related Integ rated
Related Activities Activities Activities
Commercial Scale Definition of commercial Development a
of control ProcesS-specific operating9
Manufacturing for process design strategy for commercial procedures (e.g. sampling plans,
Drug Product Commercial scale runs to verify manufacturing. including in- design space etc.)
process design, with additional process controls, end-product Documentation to support on-line
sampling to verify testing, raw material controis testing methods
understanding and change control Validation to demonstrate process
Implementation of on-line
measurement technologies
Check procedures in the PQs
regarding risk from Process
and analytical method
reproducibility
O
specific procedure (e.g. Storage of development reports,
sampling plans, design space risk assessments
and model verification, change
control for movement within
design space)

Continual Process O going analysis and trending Manage risks of process or Procedures on process
Verification and of process data, (multivariate material attribute change monitoring and action limits
Continual SPC, etc.) (including changes within or Change control procedures
Improvement Evaluation of process changes outside of design space) including how and when to do risk
and associated effect on Review risks in assessment for process changes
inte rmediates and products audits/inspections and and evaluation of the change
mplemept rigk-baseddCAPAS Maintenance and update of
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Key Messages
ICH Q8, Q9 and Q10 are linked togetherto provide a systematic,
modern risk- and science- based approach to pharmaceutical
manufacturing and development
Comprehensive implementation ofthe three guidelines together
is essential to achieve ICH Quality Vision
Guidelines are applicable overentire product lifecycle O
Guidelines can be utilized by all stakeholders
Industry and regulators
Assessors and inspectors are expected to incorporate QRM
during regulatory processes

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What is ISO 13485

Medical devices - Quality management systems
Requirements for regulatory purposes.
An organization needs to demonstrate its ability to provide medical
devices and related services that consistently meet customer and
applicable regulatory requirements
Organizations can be involved in one or more stages of the ife-cycle,
including design and development, production, storage and distribution,
installation, or servicing of a medical device and design and
development or provision of associated activities.

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Reason for Use

O While it remains a stand-alone document, ISO 13485 is generally
harmonized with ISO 9001.
OA principal difference, however, is that ISO 9001 requires the
organization to demonstrate continual improvement,
OWhereas ISO 13485 requires only that the certified organization
demonstrate the quality system is effectively implemented and
maintained.
O Additionally, the ISO 9001 requirements regarding customer
satisfaction are absent from the medical device standard.

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Certification Process

An initial discussion about existing practices to

Phase 1 evaluate.

A complete gap analysis of your company with respect

Phase 2 to your certification requirement.

A custom written mandatory certification

Phase 3 documentation, training and complete pre-assessment.

Certification audit by certification body guaranteed

Phase 4 Success

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Thank you

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