Pharmaceutical Regulataory Affairs

1. INDUSTRY AND FDA LIAISON &
ICH – Q GUIDELINES
K. Bhanu Sri Chandana
2020MPH40A023
M. PHARMACY
Dept. of Pharmaceutics
Under the guidance of
Dr. K. Sai Sruthi
M. Pharmacy, Ph. D

2.  FDA and Industrial Liaison
 FDA and its responsibilities
 Missions of FDA
 FDA Organizations and contacts
 FDA initiatives for speed drug approval
 ICH
 Introduction to ICH
 Working groups of ICH
 ICH – Q guidelines
 References
CONTENTS

3. Industry and FDA Liaison

4. Introduction
 Liaison means Communication or Co-operation.
 Every Pharmaceutical industry must follow some of the regulations held by its
higher authorities.
 FDA also lays some of the regulations in order to maintain the quality and safety of
drugs and pharmaceutical products.
 Effective communication should be maintained between Pharmaceutical Industries
and FDA .

5. Food and Drug Administration
 FDA is one of the United States oldest consumer protection agencies.
 It is a federal agency of the Department of Health and Human Services,
formed on June 30, 1906.
 Its Headquarters is the White Oak Campus which is located at Maryland.
 It is led by the ‘Commissioner of Food and Drugs’ who as appointed by the
President along with the consent of the Senate.
 Currently, Janet Wood Cook is acting as the commissioner of FDA since
January 20, 2021.
 FDA is charged with protecting American consumers by enforcing the
Federal Food, Drug and Cosmetic Act and some of the public related health
laws and has 223 field offices and 13 laboratories located throughout 50 states.

6. Responsibilities of FDA
FDA is responsible for protecting and promoting public health through
control and supervision of the following categories :
 Food safety and Dietary supplements
 Animal foods and feeds
 Tobacco products
 Prescription and other OTC drugs
 Vaccines and Biopharmaceuticals
 Blood transfusions
 Medical devices
 Cosmetics
 Veterinary products

7. Missions of FDA
1. Inspections and legal sanctions
2. Scientific expertise
3. Product safety
To ensure the safety and effectiveness of the products
under its jurisdiction, FDA sets the following missions:

8. 1. Inspections and Legal sanctions
 The investigators and inspectors visit more than 16,000 facilities a year,
for ensuring the product safety and label truthfulness.
 As a part of investigation, FDA scientists collect about 80,000 domestic
and imported samples for the examination of label checks.
 Any company found violating the laws, FDA suggests to correct the
problem voluntarily or asks to recall the product from the market.
 If the company does not obey FDA, it has all the rights to enforce legal
actions and proceed to the court to stop the product selling.
 Criminal penalties and prison sentences can be imposed against
manufacturers and distributors.

9. 2. Scientific expertise
 Scientific evidence needed for filing a case against any
company can be prepared by nearly 2,100 scientists including
900 chemists and 300 microbiologists.
 Among all these scientists, some look after analyzing samples
and others review the test results which are submitted by the
companies seeking approval for drugs, vaccines, food
additives, coloring agents.
 This agency determines the benefits of the new drug products
over its side effects.

10. 3. Product Safety
 To protect the safety and wholesomeness of product, the
samples are tested for any pesticidal residues that are
unacceptable.
 If contaminants are identified, FDA takes corrective action
and also sets labelling standards for consumers knowledge.
 FDA is also responsible for nations blood supply.
Investigators routinely examine the blood banks and records
the contaminants
 FDA ensures the purity and effectiveness of cosmetics,
medical devices vaccines and insulin.

11. FDA’s Organizations
National Center for Toxicological Research Center for Food Safety and Applied Nutrition
Center for Tobacco Products Center for Veterinary Medicine Office of Women’s Health

12. Center for Biologics Evaluation and
Research
Office of Regulatory Affairs
Office of International Programes
Center for Drug Evaluation and Research
Center for Devices and
Radiological Health

13. Center Area of Responsibility
Center for Drug Evaluation and Research Safety and effectiveness of Prescription and OTC drugs
Center for Biologics Evaluation and Research Safety and effectiveness of vaccines, nation’s blood
supply, Biologics
Center for Devices and Radiological Health Safety and effectiveness of Medical devices, diagnostic
tests, Radiation emitting devices
Center for Food Safety and Applied Nutrition Safety of domestic and imported food supply, cosmetics
and dietary supplements
Center for Veterinary Medicine Safety and effectiveness of veterinary drugs
Center for Tobacco Products Implementation of the Family Smoking Prevention and
Tobacco Control Act
National Center for Toxicological Research Research to support regulatory decisions and reduce risks
associated with FDA regulated products
Office of Regulatory Affairs Enforcement of Laws and regulations
Table

14. FDA initiatives to speed drug approval
Subpart E in Section 312 of the Code of Federal
Regulations, FDA establishes some procedures to speedup the process
of development, evaluation, and marketing of new therapies to treat
people with life-threatening and severely debilitating illnesses,
especially where no satisfactory alternatives exist.
A. Accelerated development or Review Program
B. Treatment IND
C. FDA guidelines

15. ICH – Q Guidelines

16. ICH
 International Council for Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH)
 It is a joint initiative involving both the regulatory authorities and research based
pharmaceutical industries of the European Union, Japan and the United states.
 It is an international non-profitable association that involves the scientific and technical
discussions of the testing procedures required to assess and ensure the safety, quality,
efficacy and other multidisciplinary activities of medicines.
 ICH is formed in April 1990, with an objective of coordinating the regulatory authorities
and pharmaceutical industries for better harmonisation.

17. Mission
Harmonisation for Better Health
ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and
high quality medicines are developed and registered in the most resource-efficient manner.
 Harmonisation is achieved through the development of ICH Guidelines via a process of scientific
consensus with regulatory and industry experts working side-by-side.
 Reason for the success of this process is the commitment of the ICH regulators to implement the final
Guidelines.
 ICH is an international non-profit Association which is under Swiss law on October 23, 2015.

18. Organisation of ICH

19. Auditors
 The Auditors are responsible to audit the financial statements of the Association upon conclusion of
each Fiscal Year.
 They should ensure that the accounting of the Association complies with Swiss law and generally
accepted Swiss accounting principles.
 The Auditors are appointed for a period of two years

20. Assembly
 The ICH Assembly brings together all Members and Observers of the ICH Association as the
overarching governing body of ICH.
 It makes decisions on matters such as on the Articles of Association, admission of new Members
& Observers and adoption of ICH Guidelines.
 The Assembly meets biannually and the reports are made available on the ICH website
summarizing the main decisions taken at each meeting

21. Members
1. European Union (EU)
2. European Federation of Pharmaceutical Industries and Associations (EFPIA)
3. Ministry of Health , Labour and Welfare (MHLW)
4. Japan Pharmaceutical Manufacturers Association (JPMA)
5. Food and Drug Administration (FDA)
6. Pharmaceutical Research and Manufacturers of America (PhRMA)
Observers
1. World Health Organization (WHO)
2. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

22. Management Committee
 The ICH Management Committee (MC) is the body that oversees operational aspects of ICH on behalf of
all Members, including administrative and financial matters and oversight of the Working Groups (WGs).
 The MC is responsible for submitting recommendations or proposals to the Assembly in preparation of
Assembly discussions.
MedDRA Management Committee
 The MedDRA Management Committee (MC) has responsibility for direction of MedDRA.
 It is a ICH standardised dictionary of medical terminology.
 The MedDRA MC is composed of the EC, EFPIA - Europe; ; MHLW, JPMA - Japan; ; FDA, PhRMA -
United States; Health Canada - Canada; and WHO

23. Working Groups

24. Quality Guidelines
Harmonisation achievements in the Quality area includes 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.
Safety Guidelines
ICH has produced a comprehensive set of safety Guidelines to
uncover potential risks like carcinogenicity and genotoxicity.

25. Efficacy Guidelines
The work carried out by ICH under the Efficacy 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.
Multidisciplinary Guidelines
These 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)

26. ICH – Q Guidelines

27. Q1A – Q1F Stability
Q2 Analytical Validation
Q3A – Q3E Impurities
Q4A – Q4B Pharmacopoeias
Q5A – Q5E Biotechnological Products
Q6A – Q6B Specifications
Q7 Good Manufacturing Practices
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of drug substances
Q12 Lifecycle Management
Q13 Continuous Manufacture of drug substances and Drug Products

28. Sub – parts of ICH – Q Guidelines
 Q1A (R2) - Stability Testing of New Drug Substances and Products
This guideline provides recommendations on stability testing protocols including temperature, humidity
and trail duration for different climatic zones in order to minimize the difference storage conditions for
global submission.
 Q1B - Stability Testing : Photostability Testing of New Drug Substances and Products
This Guideline gives basic testing protocols required to evaluate the light sensitivity and stability of
new drugs and products.
 Q1C - Stability Testing For New Dosage Forms
It extends the main stability guideline for new formulations of already approved medicines.

29.  Q1D - Bracketing and Matrixing Designs For Stability Testing of New Drug Substances and Products
This is intended to address recommendations on the application of Bracketing and Matrixing to
stability studies.
 Q1E - Evaluation of Stability Data
 Q1F - Stability Data Package For registration Applications in Climatic Zones III and IV
 Q2 (R1) - Validation of Analytical Procedures : Text and Methodology
 Q2 (R2) - Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
 Q3A (R2) - Impurities in New Drug Substances
This guideline Addresses the chemistry and safety aspects of impurities and identification and
qualification of the drug products

30.  Q3B (R2) - Impurities in New Drug Products
• This guideline focuses on impurities in new drug substances and provides advice in regard to impurities in
products containing new, chemically synthesized drug substances .
• It deals with the impurities that arises by degradations, interactions between drug substance and excipients.
 Q3C (R8) - Maintenance of The Guideline For Residual Solvents
• It provides recommendations on the use of less toxic solvents in the manufacture of drug substances and dosage
forms.
• It sets the pharmaceutical limits for residual solvents in drug products.
 Q3D (R1) - Guidelines for Elemental Impurities
• This guideline is implemented for the control of elemental impurities in new drug products

31.  Q3D (R2) - Revision of Q3D (R1) cutaneous and transdermal products
 Q3D Training - Implementation of Guideline For Elemental Impurities
 Q3E - Impurity : Assessment and Control of Extractables and Leachables For Pharmaceutical and Biologics
 Q4A - Pharmacopoeial Harmonisation
• The pharmacopoeial authorities works together through the Pharmacopoeial Discussion Group
 Q4B - Evaluation and Recommendation of Pharmacopoeial Texts for Use in The ICH Regions
 Q5A - Viral Safety Evaluation of Biotechnology Products Derived form Cell Lines of Human or Animal Origin
 Q5B - Analysis of The Expression Construct in cells Used for Production of r - DNA Derived Protein Products
This document is intended to describe the types of information that are considered valuable in assessing the
structure of expression construct used to produce r - DNA derived proteins

32.  Q5C - Quality of Biotechnological Products : Stability Testing of Biological Products
• This document augments the stability Guideline (Q1A) and deals with the particular aspects of stability
test procedures needed to take account of the special characteristics of products in which the active
components are typically proteins and/or polypeptides.
 Q5D - Derivation and Characterization of Cell Substrates Used for Production of Biological Products
• This document provides broad guidance on appropriate standards for the derivation of human and animal
cell lines and microbial cells used to prepare biotechnological/biological products, and for the preparation
and characterization of cell banks to be used for production.
 Q5E - Comparability of Biological Products Subject to Changes in their Manufacturing Process
• The objective of this document is to provide principles for assessing the comparability of
biotechnological/biological products before and after changes are made in the manufacturing process for
the drug substance or drug product.

33.  Q6A - Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
• This document provides guidance on the setting and justification of acceptance criteria and the selection of
test procedures for new drug substances of synthetic chemical origin, and new drug products produced
from them, which have not been registered previously in the ICH regions.
 Q6B - Specifications : Test Procedures and Acceptance Criteria for Biological Products
• This document provides general principles on the setting and justification of a uniform set of international
specifications for proteins and polypeptides which are produced from recombinant or non-recombinant
cell-culture expression systems.
 Q7 - Good Manufacturing practice for active Pharmaceutical Ingredients
• This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the
manufacturing of Active Pharmaceutical Ingredients (APIs) under an appropriate system for managing
quality.

34. • It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport
or are represented to possess.
• This Guideline applies to the manufacture of APIs for use in human drug (medicinal) products.
• It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being
rendered sterile.
• The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be
performed in accordance with GMP guidelines for drug (medicinal) products as defined by local
authorities.

35.  Q8 (R2) - Pharmaceutical Development
• This Guideline is intended to provide guidance on the contents for drug products as defined the Common
Technical Document
 Q9 - Quality Risk Management
• This Guideline provides principles and examples of tools for quality risk management that can be applied
to different aspects of pharmaceutical quality.
• These aspects include development, manufacturing, distribution, and the inspection and
submission/review processes throughout the lifecycle of drug substances, drug products, biological and
biotechnological products.
 Q10 - Pharmaceutical Quality System
• This Guideline applies to the systems supporting the development and manufacture of pharmaceutical drug
substances and drug products, including biotechnology and biological products, throughout the product
lifecycle.

36.  Q11 - Development and Manufacture of Drug Substances
 Q12 - Technical and Regulatory considerations for Pharmaceutical Product Lifecycle Management
• This new Guideline is proposed to provide 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.
 Q13 - Continuous Manufacturing of Drug substances and Drug Products
• Capture key technical and regulatory considerations that promote harmonisation, including certain Current
Good Manufacturing Practices (CGMP) elements specific to Continuous Manufacturing (CM),
• Allow drug manufacturers to employ flexible approaches to develop, implement, or integrate CM for the
Manufacture – drug substances and drug products – of small molecules and therapeutic proteins for new and
existing products.

37.  Q14 – Analytical procedure Development and Revision of Q2 (R1) Analytical Validation
• This new guideline is proposed to harmonise the scientific approaches of Analytical Procedure
Development, and to provide the principles relating to the description of Analytical Procedure
Development process.
• This new guideline is intended to improve regulatory communication between industry and regulators
and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change
management of analytical procedures.

38. References
 New Drug Approval Process – Fourth edition Accelerating Global
Regulations, Edited by Richard A. Guarino, M.D.
 www.fda.gov
 www.ich.org