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Quality Control Quality Assurance

The document provides an overview of the International Council for Harmonization (ICH) guidelines categorized into Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M). ICH was created in 1990 to harmonize technical requirements for pharmaceutical registration between Europe, Japan, and the US. The Q guidelines cover quality control areas like stability testing and impurity thresholds. The S guidelines address safety aspects like carcinogenicity and genotoxicity studies. The E guidelines concern clinical trial design, reporting, and specific populations. The M guidelines cover topics that do not fit uniquely into the other categories.

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Vaishali Gadhe
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81 views

Quality Control Quality Assurance

The document provides an overview of the International Council for Harmonization (ICH) guidelines categorized into Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M). ICH was created in 1990 to harmonize technical requirements for pharmaceutical registration between Europe, Japan, and the US. The Q guidelines cover quality control areas like stability testing and impurity thresholds. The S guidelines address safety aspects like carcinogenicity and genotoxicity studies. The E guidelines concern clinical trial design, reporting, and specific populations. The M guidelines cover topics that do not fit uniquely into the other categories.

Uploaded by

Vaishali Gadhe
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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QUALITY CONTROL QUALITY ASSURANCE

OVERVIEW OF ICH GUIDELINES


( Q ,S ,E , M)

Represented By : Guided By :
Pratiksha Shivaji Batwal Prof . Vishaka Waghle ( R.G
Roll No . – 03 Sapkal Collage Of Pharmacy
CONTENT
INTRODUCTION
MISSION OF ICH
ICH MEMBERS
PROCESS OF HARMONIZATION
QUALITY (Q) GUIDELINES
SAFETY (S) GUIDELINES
EFFICACY (E) GUIDELINES
MULTIDICIPLINARY (M) GUIDELINES
INTRODUCTION
International Conference on Harmonization of technical
Requirement and registration of pharmaceutical for Human use
ICH was created in April 1990 .
The European medicinal agency published scientific
guidelines that and harmonized - Europe, Japan & America.
Ich guidelines
The International Council for Harmonization (ICH) of Technical
Requirements for Pharmaceuticals for Human Use is unique in bringing
together the regulatory authorities and pharmaceutical industry to
discuss scientific and technical aspects of drug registration
Regulatory Authorities ICH Pharmaceutical Industry
Bringing together

To discuss scientific and technical aspects of drug registration


Mission
It monitors, updates and prevent the international
harmonization of technical requirement .
It ensure safety, efficacy and quality of medicines that should
be developed in an efficient and cost- effective manner .
It Promote and prevent public health.
It prevent unnecessary duplication of clinical trials in human.
It Reduce animal testing without compromising the safely &
effectiveness of global drug development.
Ich members
Regulatory member
European embers
FDA (USA)
Ministry of health ,labour and welfare MHW (Japan).
Ministry of food and drug safety (MFDS).

Industrial member
Japan pharmaceutical manufacture association (JAMA )Japan
Biotechnology innovation organization.(Bio)
Pharmaceutical research as manufacturing of America
World self-medication industry (WSMA)
PROCESS OF HARMONIZATION
Formal ich procedure = new topic for harmonization)
Q and A procedure = classification for an existing ICH
guideline
Revision PROCEDURE = adding new information /
procedure TO an existing ICH guideline.
Maintenance procedure =during procedure maintained
problems.
Implementation= complete prepare than publish in market
ICH GUIDELINES
The ICH topics are divided into four categories and ICH topic
codes are assigned according to these categories-
Quality guidelines (Q)
Safety guidelines (S)
Efficacy guidelines (E)
Multidisciplinary guidelines (M)
QSEM GUIDELINES
Quality (Q1 to Q11 level)
It means testing stability of API and excipient.

Safety (S1 to S 10 level )


It means invitro and in vivo preclinic studies .

Efficacy (E1 to E18 level)


Clinical study in human being.

Multidisciplinary guidelines ( M1 to M11) level


It means above (QSE) guidelines not fit then M guidelines should follow.
QUALITY GUIDELINES
QUALITY GUIDELINES (Q)
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 (GMP) risk management
Q SERIES GUIDELINES
Q1A-Q1F (Stability)
Q2 (Analytical Validation)
Q3A-Q3D (Impurities)
Q4-Q4B (Pharmacopoeias)
Q5A-Q5E(Quality of Biotechnological Products)
Q6A-Q6B (Specifications)
Q7 (Good Manufacturing Practice)
Q8 (Pharmaceutical Development)
Q9 (Quality Risk Management)
Q9 (Quality Risk Management)
Q10 (Pharmaceutical Quality System)
Q11 (Development and Manufacture of Drug Substances)
Q12 (Lifecycle Management)
Q13(Continuous Manufacturing of Drug Substances and Drug
Products)
Q14 (ANALYTICAL PROCEDURE DEVELOPMENT)
SAFETY GUIDELINES
ICH has produced a comprehensive set of safety Guidelines to
uncover potential risks like carcinogenicity, genotoxicity. A
recent breakthrough has been a non-clinical testing strategy for
assessing the QT interval prolongation liability (the single
most important cause of drug withdrawals in recent years)
S SERIES GUIDELINES
S1A-S1C (Carcinogenicity Studies)
S2 (Genotoxicity Studies)
S3A-S3B (Toxicokinetic and Pharmacokinetics)
S4 (Toxicity Testing)
S5 (Reproductive Toxicology)
S6 (Biotechnological Products)
S7A-S7B (Pharmacology Studies)
S8 (Immunotoxicology Studies)
S9 (Nonclinical Evaluation for Anticancer Pharmaceuticals)
S10 (Photosafety Evaluation)
S11 (Nonclinical Paediatric Safety)
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 processes and the use of
pharmacogenetics /genomics techniques to produce better
targeted medicines.
E SERIES GUIDELINES
E1 (Clinical Safety for Drugs used in Long-Term Treatment)
E2A-E2F (Pharmacovigilance)
E3 (Clinical Study Reports)
E4 (Dose-Response Studies)
E5 (Ethnic Factors)
E6 (Good Clinical Practice)
E7 (Clinical Trials in Geriatric Population)
E8 (General Considerations for Clinical Trials)
E9 (Statistical Principles for Clinical Trials)
E10 (Choice of Control Group in Clinical Trials)
MULTIDICIPLINARY 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)
M SERIES GUIDELINES
M1 (MedDRA Terminology)
M2 (Electronic Standards)
M3 (Nonclinical Safety Studies)
M4 (Common Technical Document)
M5 (Data Elements and Standards for Drug Dictionaries)
M6 (Gene Therapy)
M7 (Mutagenic impurities)
M8 (Electronic Common Technical Document i.e., eCTD)
M9 (Biopharmaceutics Classification System-basedBiowaivers)
M10 (Bioanalytical Method Validation)
M11 (Clinical electronic Structured Harmonised Protocol i.e., CeSHarP)
M12 (Drug Interaction Studies)
REFERENCE
MANOHAR A. POTDAR (NIRALI PRAKASHAN )
PHARMACEUTICAL QUALITY ASSURANCE
(PAGE NO - 12.1 )
THANK YOU

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