Understand 14 ICH guidelines in the pharmaceutical in an easy way

ICH full formInternational Council on Harmonisation of a technical requirement for registration of pharmaceutical for human use.

 ICH is a joint initiative of three different regulatory bodies (USA, Europe, and Japan) as per their region to discuss scientific and technical aspects for the registration of a product. ICH is formed to harmonize global pharmaceutical manufacturing practices.

  ICH having four guidance category Quality, Safety, Efficacy, and Multidisciplinary.

 Today here out of four you will get a brief idea about what is ICH Quality Guideline.

  In ICH categories, the first category is ICH Quality Guideline, it includes 14 guidelines. Each guideline having codes. Here we go to discuss one by one.

Table of Contents

ICH Quality Guidelines:

1. Stability (Q1) 

Stability ich quality guideline explains the stability testing, photostability, evaluation of drug substance, and drug product.

 Stability guideline having 6 codes as,

Q1A(R2): Stability testing of new drug substance and drug product

  This code represents the stability testing of new drug substance and drug products, which includes protocol study, temperature, humidity, and trial duration of climatic zones.

Q1B: Photostability testing of new drug substance and drug product

This code explains about the photostability of the drug substance and drug product.

This is required to evaluate the light sensitivity of the drug substance and drug product. This forms an annex to the stability guideline.

Q1C: Stability testing of New dosage form

This code is a guideline for new drug formulations which is already approved and defines the circumstances under which reduced stability data can be accepted.

Q1D: Bracketing and matrixing design for stability testing of new drug substance and drug product

This code is described about the Bracketing and matrixing design for stability testing of new drug substance and drug product. It is generally used to reduced the testing frequency of the analysis.

Q1E: Evaluation of stability data

This code is to explain the evaluation of stability data. The possible situation where extrapolation of retest period or shelf life lives beyond the real-time data may be appropriate.

It provides an example of statistical approaches to stability data analysis.

Q1F: Stability data package for registration and application for climatic zone III and IV

This ich code defines a data package for Registration application in climatic zone III and IV. ICH committee decided to leave the definition of storage conditions in climatic zone III and IV to the respective zones and WHO.


This ich code is withdrawn in June 2008.

2. Analytical Validation (Q2)

This guideline describes to the analytical method development and analytical method validation.

Q2(R2)/ Q14: Analytical procedure development and revision of Q2(R1) analytical validation

Q2(R2) is a revision of Q2(R1) which explains the analytical procedure development and procedure validation for simplification and clarity.

Q2(R1): Validation of analytical procedure: Text and methodology

This code describes the need of varieties of analytical methods and experimental data required along with statistical interpretation for the validation of analytical procedure.

ICH Q2 Guideline
ICH Q2 Guideline

3. Impurities (Q3)

This ich quality guideline addresses the impurity profile and it’s acceptance criteria.

Q3A(R2): Impurities in new drug substance

This code describes the chemistry and safety aspects of impurities. It defines the listing of impurity in specification and threshold of reporting, identification, and qualification.

Q3B(R2): Impurities in new drug product

This code is dealing with impurities arise from degradation product of drug substance or arise due to interaction between drug substance and excipient or components of primary packaging material, and set rationale for reporting threshold, identification and qualification of such impurities.

Q3C(R7): Guideline for residual solvents

This code describes to use of less toxic solvents in the manufacturing of drug substance and dosage form and set Acceptance criteria for residual solvents for the manufacturing of drug products.

Q3D(R1): Guideline for Elemental Impurities

This Code describes about to control and establish the limit for Elemental Impurities by studying various route of Administration.

Q3D(R2): Revision of Q3D(R1) for cutaneous and transdermal product

This code is describe about to take consideration of the cutaneous and transdermal route of administration.

4. Pharmacopeias (Q4)  

Q4A: Pharmacopoeial harmonization

This code is details about to harmonization of the ICH region for pharmaceuticals.

Q4B: Evaluation and Recommendation of Pharmacopoeial text for use in the region of ICH

This code describes a process for evaluation and recommendation of selected Pharmacopoeial texts to facilitate their recognition by a regulatory authority.Q4B having different annex for different tests.

Total 14 annexes available in Q4B code

Q4B Annex 1R1: Dedicated for Residue on Ignition or Sulfated Ash General chapter
Q4B Annex 2R1: Dedicated for test for extractable volume of parenteral preparation.
Q4B Annex 3R1: Dedicated for Tests for particulate contamination.
Q4B Annex 4AR1: Dedicated for microbial enumeration test for Non-sterile products.
Q4B Annex 4BR1: Dedicated to the test of specified microorganisms for Non-sterile products.
Q4B Annex 4C1: Dedicated to Acceptance criteria for pharmaceutical preparation and substance for pharmaceutical use of Non-sterile products.
Q4B Annex 5R1: Dedicated for Disintegration test general chapter
Q4B Annex 6: Uniformity of dosage unit test general chapter
Q4B Annex 7R2: Dedicated for Dissolution test general chapter
Q4B Annex 8R1: Dedicated for sterility test general chapter
Q4B Annex 9R1: Dedicated for Tablet Friability general chapter
Q4B Annex 10R1: Dedicated for polyacrylamide gel electrophoresis general chapter.

Q4B Q4 Annex11: Dedicated for Capillary electrophoresis general chapter
Q4B Annex 12: Analytical sieving general chapter
Q4B Annex 13: Dedicated for Bulk density and tap density of powders general chapter.
Q4B Annex 14: Dedicated to Bacterial endotoxin test general chapter.

Also Read:

Data Integrity and ALCOA Plus in pharmaceutical industry

Current Good Manufacturing Practices (cGMP) in Pharmaceutical industry

5. Quality Biotechnological product (Q5)

 This ich quality guideline is for Biotechnological products. In this having 5 codes

Q5A(R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.

This code is described about the viral testing experiment for evaluation of viral clearance and the design of viral test and clearance evaluation studies.

Q5B: Analysis of expression construct in the cell used for the production of r-DNA derived protein product.

This code is about Assessing the structure of the expression constructs used to produce recombinant DNA derived protein.

Q5C:  Stability Testing of Biotechnological/biological product.

This code Is deals with the particular aspect of the Stability test procedure needed to take account of the special characteristics of the product in which the active component is typically protein and/or polypeptide.

Q5D: Derivation and characterization of cell substrates used for the production of Biotechnological and biological products.

This code provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbes used to prepare Biotechnological/ biological products.

Q5E: Comparability of Biotechnological/biological products subjects to change in their manufacturing process

This code describes the Comparability of drug substance and product and collected information gives evidence of changes in the manufacturing process will not have any adverse impact on the Quality, safety, and Efficacy of the product.

6. Specification (Q6)

 This ICH Quality Guideline deals with procedure and acceptance criteria for drug substance, drug product, biological/ Biotechnological product.

Q6A: Test procedure and Acceptance criteria for new drug substance and new drug product

This code addresses a selection of test and method and setting a specification for drug substance and drug product.

Q6B: Test procedure and Acceptance Criteria for Biotechnological/biological product

This code provides a guidance for setting up a specification of protein and polypeptide which are derived from cell culture.

7. Good Manufacturing Practices (Q7)

This Quality Guideline demonstrates the good Manufacturing Practices throughout the ICH region for uniform practices.

8. Pharmaceutical Development (Q8)

The aim of pharmaceutical development is to design a quality product and it’s a manufacturing process to consistently deliver the intended performance of the drug product.

9. Quality Risk Management (Q9)

This ich guideline provides a risk-based approach applied to all aspects of pharmaceutical quality including manufacturing, development, distribution, and inspection. Also applied for Biotechnological and biological aspects.

ICH
ICH Q9 Guideline

10. Pharmaceutical Quality System (Q10)

This guideline is introduced for pharmaceutical manufacturers to implement an effective quality system in the pharmaceutical industry.

11. Development and manufacturing of drug substance (Q11)

This guideline describes the harmonization of active pharmaceutical ingredients (APIs) in a scientific and technical manner for the development and manufacturing process. The drug substance includes both chemical entities and biological/Biotechnological entities.

12. Lifecycle Management (Q12)

This guideline describes about the framework to facilitate the management of post-approval chemistry, manufacturing, and control changes in a more predictable and efficient manner across the product lifecycle.

13. Continuous manufacturing of drug substance and drug product (Q13)

This guideline provides guidance to industry and regulatory agencies regarding regulatory expectations on development, implementation, and assessment of continuous manufacturing technologies used in the manufacturing of drug substance and drug products.

 14. Analytical Procedure Development (Q14)

This guideline is intended to improve a regulatory communication between regulator and industry and facilitate more efficient, sound scientific and risk-based approval and post-approval change management of analytical procedure.

ICH is formed in April 1990.
The purpose of the ICH is to Harmonize the manufacturing process and to get uniform output with respect to Safety, Quality, and Efficacy throughout the world.

ICH Organogram
ICH Organogram

Read More:

What is Drug Master File (DMF)

Contamination, Cross-contamination and Mix-ups in pharmaceutical

Leave a Comment

11 + eleven =

x