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Available online at ajdhs.com 

Asian Journal of Dental and Health Sciences 
Open Access to Pharmaceutical and Medical Research 

Copyright  © 2022 The  Author(s): This is an open-access article distributed under the terms of the CC BY-NC 4.0 
which permits unrestricted use, distribution, and reproduction in any medium for non-commercial use provided the 

original author and source are credited 
 

 

 

Compressive Review on Role of ICH Guidelines in Registration of 
Pharmaceutical Products 

Paramlal Ahirwar, Basant Khare*, Prateek Kumar Jain, Anushree Jain, Rubeena Khan, Bhupendra Thakur 

Adina College of Pharmacy, ADINA Campus Rd, Lahdara, Sagar, MP, 470001 

Article Info: 
_______________________________________
Article History: 

Received 03 July 2022      
Reviewed 21 Aug 2022 
Accepted 27 Aug 2022 
Published 15 Sep 2022 

_______________________________________ 
Cite this article as:  

Ahirwar P, Khare B, Jain PK, Jain A, Khan R, 
Thakur B, Compressive Review on Role of ICH 
Guidelines in Registration of Pharmaceutical 
Products, Asian Journal of Dental and Health 
Sciences. 2022; 2(3):1-8 

DOI: http://dx.doi.org/10.22270/ajdhs.v2i3.16                                    

_______________________________________
*Address for Correspondence:   
Mr .  Basant Khare, Adina College Of Pharmacy,  
ADINA Campus Rd, Lahdara, Sagar, MP, 470001 

Abstract 
___________________________________________________________________________________________________________________ 

The International Conference On Harmonization (ICH) Of Technical Requirements Is A Unique Project 
For Registration Of Pharmaceutical Products Which Are Intended For Human Use. This Brings Together 
The Regulatory Authorities Of Europe, Japan And United States And Experts From The Pharmaceutical 
Industry In The Three Regions To Discuss Scientific And Technical Aspects Of Product Registration.The 
Purpose Is To Make Recommendations On Ways To Achieve Greater Harmonization In The 
Interpretation And Application Of Technical Guidelines And Requirements For Product Registration In 
Order To Reduce Or Obviate The Need To Duplicate The Testing Carried Out During The Research And 
Development Of New Medicines.The Objective Of Such Harmonization Is A More Economical Use Of 
Human, Animal And Material Resources And The Elimination Of Unnecessary Delay In The Global 
Development And Availability Of New Medicines Whilst Maintaining Safe Guards On Quality, Safety And 
Efficacy And Regulatory Obligations To Protect Public Health. It Creates A Venue That Allows All Key 
Pharmaceutical Regulatory Authorities And Industry Stakeholders The Opportunity To Be More Actively 
Involved In Pharmaceutical Harmonization Work. It Aimed At The Standardization Of Requirements 
And Format Along With The Content Of Regulatory Documentation And Brings Down The Pressure On 
The Price Of Medicines By Enabling Greater Economies Of Scale And A Labelled Regulatory Playing 
Field. This Paper Is An Effort To Provide The Detailed Information About ICH Guidelines. 

Keywords: International Conference On Harmonization, Product Registration, Medicines, 
Pharmaceutical 

E-Mail: Basant.Khare08@Gmail.Com 

Introduction 

The International Council For Harmonisation Of Technical 
Requirements For Pharmaceuticals For Human Use (ICH) 1 Is 
A Unique Project In Bringing Together The Regulatory 
Authorities And Pharmaceutical Industry To Discuss Scientific 
And Technical Aspects Of Drug Registration. Since Its 
Inception In 1990, ICH Has Gradually Evolved, To Respond To 
The Increasingly Global Face Of Drug Development. 
Harmonisation Leads To A More Sensible Use Of Human, 
Animal And Other Resources, The Elimination Of Unnecessary 
Delay In The Global Development, And Availability Of New 
Medicines While Maintaining Safeguards On Calibre, Welfare, 
Efficacy, And Regulatory Obligations To Protect Public Health. 
Harmonisation Can Be Achieved Through The Development Of 
ICH Guidelines Via A Process Of Scientific Consensus With 
Regulatory And Industry Experts Working Side-By-Side. The 
Basic Key To The Success Of This Process Is The Commitment 
Of The ICH Regulators To Implement The Final Guidelines. The 
Mission Of ICH Is To Make Recommendations Towards 
Achieving Greater Harmonisation In The Interpretation And 
Application Of Technical Guidelines And Requirements For 
Pharmaceutical Product Registration And The Maintenance Of 
Such Registrations. It Also Monitors And Update Harmonised 
Technical Requirements Leading To A Greater Mutual 
Acceptance Of Research And Development Data. ICH Helps To 
Facilitate The Adoption Of New Or Improved Technical 
Research And Development Approaches Which Update Or 
Replace Current Practices. It Helps To Develop Policy For The 
ICH Medical Dictionary For Regulatory Activities Terminology 
(Meddra) 2 Whilst Ensuring The Scientific And Technical 

Maintenance, Development And Dissemination Of Meddra As 
A Standardised Dictionary Which Facilitates The Sharing Of 
Regulatory Information Internationally For Medicinal 
Products Used By Humans. Its Objectives Are, Thus, As 
Follows: 

 More Efficient And Effective Use Of Human, Animal And 
Material Resources 

 Reduce The Development Times And Unwanted Delays Of 
Drugs 

 End Duplicate Clinical Trials 

 Facilitate The Concurrent Launch Of New Drug In Different 
Countries, Across All Three ICH Members 

 Create Guidelines To Ensure That The Highest Level Of 
Safety, Quality And Efficacy Is Applied To Drug 
Development, With An Eye Towards Globalization.  

Structure of ICH 3 

 ICH Assembly 

 ICH Management Committee 

 Meddra Management Committee 

 ICH Secretariat 

The ICH Assembly Works In Bringing Together All Members 
And Observers Of The ICH Association As The Overarching 
Governing Body Of ICH. It Takes Decisions On Particular 
Matters Such As On The Adoption Of ICH Guidelines, 

                       Open Access                                                                                                                                                                                                          Review Article                                                                           

http://jddtonline.info/
http://dx.doi.org/10.22270/ajdhs.v2i3.16


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Admission Of New Members And Observers, And The ICH 
Association’s Work Plans And Budget. Member 
Representatives Appointed By The Assembly Are Supported 
By ICH Coordinators Who Represent Each Member To The ICH 
Secretariat On A Daily Basis. The ICH Management Committee 
(MC) Is That Body Which Supervises The Operational Aspects 
Of ICH On Behalf Of All Members, Including Administrative 
And Financial Matters And Oversight Of The Working Groups 
(Wgs).The Meddra Management Committee (MC) Has 
Responsibility For Providing Direction Of Meddra, ICH’s 
Standardised Medical Terminology. The Meddra MC Is 
Responsible For Managing, Supporting, And Facilitating The 
Maintenance, Development, And Dissemination Of Meddra.  
The ICH Secretariat Is Responsible For Day-To-Day 
Management Of ICH, Coordinating ICH Activities As Well As 
Providing Support To The Assembly, The MC And Working 
Groups. The ICH Secretariat Also Provides Support To The 
Meddra MC. The ICH Secretariat Is Located In Geneva, The 
Development Of A New Harmonised Guideline And Its 
Implementation (The Formal ICH Procedure) Involves 5 Steps 
4 (Figure1). 

ICH Guidelines 

Objective Of ICH Is To Increase International Harmonization 
Of Technical Requirements To Ensure That Safe, Effective, And 
Higher Quality Medicines Are Developed And Registered In 
The Most Efficient And Cost Effective Manner. ICH Has 
Developed Over 45 Harmonized Guidelines.There Are Four 

Major Categories Into Which The ICH Guidelines Are Divided. 
Quality Those Relating To Chemical And Pharmaceutical 
Quality Assurance. Safety Those Relating To In Vitro And In 
Vivo Preclinical Studies. Efficacy Those Relating To Clinical 
Studies In Human Subject 5. 

 

Figure 1: Flow Chart Showing ICH Harmonization Process 

 

 



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Guidelines 

The Present Study Is An Attempt To Provide Detailed 
Information About ICH On The Basis Of Literature. 

Quality 

Stability Testing 

The Objective Of Stability Study 6 Is To Provide Proof On How 
The Quality Of Drug Substance Or Drug Product Changes With 
Time Under The Effect Of A Variety Of Environmental Factors 
Such As Temperature, Humidity And Light And Recommended 
Storage Conditions, Re-Test Periods And Shelf-Life To Be 
Established. The Choice Of Test Conditions Depends On 
Climatic Conditions In The Areas Of EU, JAPAN And USA. 

Drug Substance 

Information On The Stability Of The Drug Substance Is An 
Integral Part Of The Systematic Approach To Stability 
Evaluation. Stress Study Of The Drug Substance Can Help 
Identify The Degradation Products Which Can In Turn Help 
Establish The Degradation Pathways And Validate The 
Stability Indicating Power Of The Analytical Procedures Used 
7. The Nature Of The Stress Study Will Depend On The 
Individual Drug Substance And The Type Of Drug Product 
Used. Stress Study Is To Be Carried Out On A Single Batch Of 
The Substance. It Should Include The Effect Of Temperature, 
Humidity. The Study Should Also Evaluate The Susceptibility 
Of The Drug Substance To Hydrolysis Across A Wide Range Of 
Ph Values When In Solution Or Suspension. Photostability 
Study Should Be An Integral Part Of Stress Testing 8. The 
Standard Conditions For Photo Stability Studies Are Described 
In ICH Q1B 9. Data From Formal Stability Studies Should Be 
Provided On At Least Three Batches. The Batches Should Be 
Manufactured To A Pilot Scale By The Same Route As Used 
Earlier And Using A Method Of Manufacture And Procedure 
That Simulates The Final Process For Production Batches. The 
Stability Studies Should Be Conducted On The Drug Substance 
Packed In Final Packing. Specification Is A List Of Tests, 
Reference To Analytical Procedures And Proposed Acceptance 
Criteria, Which Are Addressed In ICH Guideline Q6A And Q6B. 
Additionally, Specification For Degradation Of Products In A 
Drug Substance Is Discussed In Q3A. Stability Studies Include 
Study Of Those Of Attributes Of The Drug Substance That Are 
Susceptible To Change During Storage And Are Likely To 
Affect Quality, Safety And Efficacy. The Study Should Cover, As 
Appropriate, The Physical, Chemical, Biological And 
Microbiological Attributes. Validated Stability-Indicating 
Analytical Procedures Should Be Applied Whether And To 
What Extent Replication Should Be Performed Will Depend On 
The Results From Validation Studies 10.  

Study Frequency 

For Long-Term Studies, Frequency Of Testing Should Be 
Sufficient To Establish The Stability Profile Of The Active 
Pharmaceutical Product (API). For Apis With A Proposed Re-
Test Period Or Shelf-Life Of At Least 12 Months, The 
Frequency Of Testing At The Long-Term Storage Condition 

Should Normally Be In Every Three Months Over The First 
Year, In Every Six Months Over The Second Year, And Annually 
Thereafter Throughout The Proposed Re-Test Period Or Shelf-
Life.At The Accelerated Storage Condition, A Minimum Of At 
Least Three Time Points, Including The Initial And Final Time 
Points (E.G. 0, 3 And 6 Months), From A Six Months Study Is 
Recommended. When A Testing At The Intermediate Storage 
Condition Is Required As A Result Of Significant Change At The 
Accelerated Storage Condition, A Minimum Of Four Time 
Points, Including The Initial And Final Time Points (E.G. 0, 6, 9 
And 12 Months), From A 12-Month Study Is Recommended. 

Storage Conditions 

In General, An API Should Be Evaluated Under Storage 
Conditions (With Appropriate Tolerances) That Test Its 
Thermal Stability And, If Applicable, Its 91 Sensitivity To 
Moisture. The Storage Conditions And The Lengths Of Studies 
Chosen Should Be Sufficient To Cover Storage And Shipment. 
Storage Condition Tolerances Are Defined As The Acceptable 
Variations In Temperature And Relative Humidity Of Storage 
Facilities For Stability Studies. In The Rare Case Of Any API Of 
Non-Biological Origin Being Intended For Storage In A Freezer, 
The Re-Test Period Or Shelf-Life Should Be Based On The 
Long-Term Data Obtained At The Long-Term Storage 
Condition. In The Absence Of An Accelerated Storage 
Condition For Apis Intended To Be Stored In A Freezer, 
Testing On A Single Batch At An Elevated Temperature (E.G. 
5°C± 3°C Or 25°C ±2°C Or 30°C ± 2°C) For An Appropriate 
Time Period Should Be Conducted To Address The Effect Of 
Short-Term Excursions Outside The Proposed Label Storage 
Condition, E.G. During Shipping Or Handling. Apis Intended 
For Storage Below -20 °C Should Be Treated On A Case-By-
Case Basis. 

Evaluation 

The Purpose Of The Stability Study Is To Establish And 
Evaluating The Stability Information Including, As 
Appropriate, Results Of The Physical, Chemical, Biological And 
Microbiological Tests, A Re-Test Period Applicable To The 
Other Batches Of The API Manufactured Under Similar 
Circumstances. The Degree Of Discrepancy Of An Individual 
Batch Affects The Conviction That A Future Production Batch 
Will Remain Within Specification Throughout The Assigned 
Re-Test Period. 

On-going Stability Studies 

The Stability Of The API Should Be Monitored On The Basis Of 
Continuous And Appropriate Programme That Will Permit The 
Detection Of Any Stability Issue (E.G. Changes In Levels Of 
Degradation Products). The On-going Stability Programme Is 
Required To Monitor The API And To Determine That The API 
Remains, And Can Be Expected To Remain, Within 
Specifications Under The Storage Conditions Indicated On The 
Label, Within The Re-Test Period In All Future Batches. The 
Ongoing Stability Programme Should Be Described In A 
Written Protocol And The Results Are Presented In A Formal 
Report.

 



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The Protocol For An On-going Stability Programme Should 
Extend To The End Of The Re-Test Period And Shelf-Life And 
Should Include The Following Parameters: 

 Number Of Batches And Batch Sizes, If Applicable; 

 Relevant Physical, Chemical, Microbiological And 
Biological Test Methods; 

 Acceptance Criteria; 

 Reference To Test Methods; 

 Description Of The Container Closure System(S); 

 Testing Frequency; 

Description Of The Storage Conditions (Standardized 
Conditions For Long-Term Testing As Described In These 
Guidelines, And Consistent With The API Labelling, Should Be 
Used); Other Applicable Parameters Specific To The API. 

Validation 

Validation Of An Analytical Procedure Is The Process By Which 
It Is Established, By Laboratory Studies So That The 
Performance Characteristics Of The Procedure Meet The 
Requirements For The Intended Analytical Applications. 
Method Validation Provides An Assurance Of Reliability 
During Normal Use, And Is Sometime Referred To As The 
Process For Providing Documented Evidence That The Method 
Does What It Is Intended To Do 11.  



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Repeatability 

Repeatability Is Termed As The Use Of The Analytical 
Procedure Within A Laboratory Over A Hort Period Of Time 
Using The Same Analyst With The Same Equipment. It Should 
Be Evaluated Using A Minimum Of Nine Determinations 
Covering The Specified Range For The Procedure (I.E., Three 
Concentrations And Three Replicates Of Each Concentration 
Or Using A Minimum Of Six Determinations At 100% Of The 
Test Concentration) 

Reproducibility 

Reproducibility Indicates The Precision Between Laboratories 
(Collaborative Studies, Usually Applied To Standardisation Of 
Methodology). It Is Usually Demonstrated By Means Of An 
Inter-Laboratory Trial 12, 13.  

• Specificity: Specificity Is The Ability To Measure Accurately 
And Specifically The Analyte Of Interest In The Presence Of 
Other Components That May Be Expected To Be Present In 
The.  

• Linearity: It Is A Mathematical Relationship Or Function 
Which Means That It Can Be Graphically Represented As A 
Straight Line. It Can Be Established Initially By Visual 
Examination Of A Plot Of Signals As A Function Of Analyte 
Concentration Of Content. It Is Suggested To Have A Minimum 
Of Five Concentration Levels, Along With Certain Minimum 
Specified Ranges. For Performing The Assay, The Minimum 
Specified Range Is From 80% -120% Of The Target 
Concentration. 

• Detection Limit And Quantitation Limit: The Detection Limit 
Refers To The Lowest Concentration Of An Analyte In A 
Sample That Can Be Detected But Cannot Quantify. The 
Quantitation Limit Refers To The Lowest Concentration Of An 
Analyte In A Sample That Can Be Determined With Acceptable 
Precision And Accuracy Under The Stated Operational 
Conditions Of The Analytical Procedures. 

 

 

Good Manufacturing Practices 

Good Manufacturing Practices (GMP) Is A Part Of Quality 
Assurance (QA) Which Ensures That Products Are 
Consistently Produced And Controlled In Accordance With The 
Quality Standards That Are Appropriate For Their Intended 
Use And As Required By The Marketing Authorization 14. GMP 
Guidelines Provide Minimum Requirements For 
Pharmaceutical Or A Food Product Manufacturer To Assure 
That The Products Are Of High Quality And Do Not Pose Any 
Risk To The Consumer. Additionally, GMP Has Issued 
Guidelines For The Achievement Of Consistent Product 
Quality, With Interpretation And Individual Variations Being 
Accepted. GMP Implemented In The United States By The US 
FDA, Under Section 501(B) Of The 1938 Food, Drug, And 
Cosmetic Act (21 USCS § 351). The Regulations Use The Phrase 
“Current Good Manufacturing Practices” (Cgmp) And It 
Describes The Guidelines 15.  

Pharmacopoeia 

A Pharmacopoeia Is A Legally Binding Collection Of Standards 
And Quality Specifications For Medicines Used In A Country Or 
Region 16. Within The Pharmacopoeia, A Quality Specification 
Is A Set Of Appropriate Tests That Will Confirm The Identity 
And Purity Of The Product, Ascertain The Strength (Or 
Amount) Of The Active Substance And, When Needed, The 
Performance Characteristics. Reference Substances That Are 
Used In Testing Help To Ensure The Quality, Strength And 
Purity Of The Drugs. A Pharmacopoeia Covers The Information 
Regarding The Pharmaceutical Starting Materials, Excipients, 
Intermediates And Finished Pharmaceutical Products (Fpps). 
Details Of General Requirements May Also Be Provided On 
Important Subjects Related To Drugs Quality, Such As 
Analytical Methods, Microbiological Purity, Dissolution 
Testing, Or Stability. The Modern Pharmacopoeia Points Out 
Certain Quality Specifications For Active Pharmaceutical 
Ingredients (Apis), Fpps And General Requirements. The 
Existence Of Such Specifications And Requirements Is 
Necessary For The Proper Functioning Or Regulatory Control 
Of Medicines Production 17. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



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Quality Guidelines 

 



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Conclusion 

The ICH Is A Major Global Undertaking To Affect The 
Harmonization Of Regulatory Requirements In The 3 Major 
Regions Involved. The Creation Of The ICH – The International 
Conference Of Harmonization, Was Fuelled By Trade Reasons, 
To Even Out The Competition Between Markets And End The 
Aforementioned Stagnation. ICH Was Created To Deliver 
Health Care Technology Providers A  Common, Almost Global 
Regulatory Framework For Them To Develop Their Products. 
The ICH’s Work Is Far From Over, As More And More 
Regulatory Scrutiny Is Demanded From Manufacturers And 
Investigators And More Pressure Is Applied To Pharmaceutical 
Companies To Increase Data Transparency, Who Look Up For 
ICH’s Guidance. 

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https://doi.org/10.22270/ijdra.v7i4.365
https://doi.org/10.1007/978-1-4614-5950-7
https://doi.org/10.22270/jddt.v8i2.1564
https://doi.org/10.7897/2230-8407.04904
https://doi.org/10.1255/tosf.61
https://doi.org/10.22270/jddt.v6i2.1201

